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NCT Number: NCT06786117

Swallowing in OSA & CPAP Intolerance

This study has two parts: an observational part and an interventional part.

The goal of the observational part of the study is to look for variations in swallowing in adults with obstructive sleep apnea (OSA) and in adults who don't snore. The main questions it aims to answer are:

* Are there differences in swallowing between people with OSA and people who don't snore? * Are there differences in swallowing between people with OSA who do well with continuous positive airway pressure (CPAP) therapy and those who struggle with CPAP?

This may help us better understand what causes OSA, which may help us develop alternate ways to treat or even prevent OSA. It may also help us improve care for people with OSA who struggle with CPAP. Participants will be aged 40-60 years, except women up to the age of 70 will be included in the healthy control (non-snorer) group.

Participants will:

* Undergo a type of x-ray study called a modified barium swallow study (MBS) * Come to MetroHealth Medical Center for a measurement visit to:

* assess the strength of their tongue, lips, and cheeks * assess the strength of their breathing muscles * assess for restrictions in tongue mobility (tongue ties) * observe their resting breathing * take photos of their mouth and posture * take videos of them drinking and eating * Complete some questionnaires * For successful CPAP users: we will download data from the chip in their CPAP device * Do a home sleep test (except for successful CPAP users who have had a recent in-lab sleep test)

The goal of the interventional part of the study is to test swallowing exercises in people ages 40-60 years with OSA who struggle with CPAP. The main question it aims to answer is:

• Can swallowing exercises help people who struggle with CPAP sleep better with CPAP?

Participants will:

* Try to use CPAP for 2 weeks with individualized support * Do all the investigations listed in the observational part of the study * Do one or two courses of swallowing exercises, each of which would last 7 weeks. Participants will be asked to do daily exercises; exercises will take 20-30 minutes to perform. * Try to use CPAP for 2 weeks after the course of exercises * Repeat the investigations listed in the observational part of the study to see if changes occurred with the swallowing exercise intervention.

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Key information

Conditions

Sleep Apnea, Obstructive Apnea Dyssomnias Healthy Nervous System Diseases Respiration Disorders Respiratory Tract Diseases Sleep Apnea Syndromes Sleep Disorders, Intrinsic Sleep Wake Disorders

Age range

40 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

MetroHealth Medical Center

Cleveland, Ohio, 44109, United States

About this study

Obstructive sleep apnea (OSA) is a common disorder in which the throat narrows abnormally or even collapses fully during sleep. The narrowing leads to sleep disruption and increases the risk of many chronic health conditions. We do not understand why the throat narrows in some people during sleep but not in others. While being overweight or obese increases a person's risk of OSA, it is only one part of the problem. Some thin adults and children have OSA, and many overweight or obese people do not have OSA. In addition, many people with OSA struggle to benefit from current OSA treatments like continuous positive airway pressure (CPAP), which uses air pressure to hold the airway open during sleep. We need improved understanding of OSA in order to improve treatment of it.

The throat is used for swallowing as well as for breathing. Hence it should not be surprising if a throat that has trouble staying open during sleep might also have some abnormalities during swallowing. Indeed, some research has shown subtle abnormalities in swallowing in people who have snoring or OSA compared to people who don't snore at all. We would like to further develop this line of research.

This study has two arms: an observational arm to look for differences in swallowing, and an interventional arm to see if swallowing exercises can improve people's ability to use CPAP.

The purpose of the observational arm is to look for differences in swallowing between healthy people and people who have obstructive sleep apnea (OSA) using a variety of measurement techniques, some of which have not been done in the past. Understanding the differences in swallowing may help us to develop new treatments for OSA. It may also help us to figure out how to prevent OSA from developing in the first place. We are also looking to see if there are swallowing differences between people with OSA who don't tolerate CPAP compared to people who do well with CPAP. If there are differences, these differences may help us better understand why some people do not tolerate CPAP, and may lead to the development of novel treatments such as exercise therapies to help them do better with CPAP.

The interventional arm will test exercise therapies to see if they will help people who struggle with CPAP. The goal is not to cure OSA, but to help people be able to use CPAP better so that they can sleep better. Participants who have abnormalities in their swallowing study will get exercises from speech language pathologists (SLP, also known as speech therapists) aimed at trying to correct those abnormalities. Participants will then try to use CPAP again. Participants who still can't sleep well with CPAP after those exercises, or who don't have abnormalities on the swallowing study, will get another type of exercise therapy based on an exercise technique called orofacial myofunctional therapy (OMT). This therapy aims to train exclusive nasal breathing and correct variations in the swallow. This sort of exercise technique has had some success in improving CPAP use as well as in reducing the severity of OSA. We have created a streamlined exercise protocol based on these techniques that we hope will provide better results in a shorter period of time. At the end of the exercise interventions, the participants will repeat the investigations that were done at the beginning of the study.

Investigations will include home sleep testing, CPAP trials (only for participants with OSA and CPAP intolerance), a modified barium swallow study (MBS), a measurement visit, and questionnaires. During the measurement visit, there will be assessments of the strength of the tongue, lips, and cheeks, assessment of nasal airflow, respiratory muscle strength, restrictions in tongue mobility (tongue tie), posture, dental and facial form, and eating and drinking. The modified barium swallow study uses x-rays; the amount of radiation from the procedure is about what a person would receive from about 4.5 months of background radiation. It is a little bit more radiation than what a person would receive from a mammogram, but much less than what a person would receive from a CT scan.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

for healthy airways participants:

  • Naturally ideal dental occlusion without orthodontic intervention, including successful eruption of wisdom teeth (without significant dental crowding, though minor rotation of less than 4 teeth will be acceptable)
  • No sleep-related complaints
  • No snoring.
  • They should be missing no more than 4 of their natural teeth, and these should have been lost to decay or accident rather than due to crowding. A person whose wisdom teeth came in successfully but were extracted "preventatively" will be eligible for the study.
  • Should be getting at least 6 hours of sleep nightly.
  • BMI between 18.5 and 35

Inclusion criteria

for participants with OSA who are successful CPAP users:

  • Participant will have experienced significant benefits from therapy and have had such benefit since the first night of use. Participant should have no significant sleep complaints when using CPAP.
  • Uses CPAP > 6 hours of nightly use on > 90% of nights using a nasal mask.
  • Residual device AHI < 5 events/hour.
  • Has used CPAP for at least 12 months.
  • Symptomatic at diagnosis, with polysomnography (PSG) showing AASM AHI 5-60 and symptoms attributable to OSA, with greater than 75% of the apneas and hypopneas being obstructive in nature. Home sleep apnea testing (HSAT) will also be accepted, with RDI 5-60, with greater than 75% of the apneas and hypopneas being obstructive in nature.
  • Should be getting at least 6 hours of sleep nightly.
  • BMI between 18.5 and 35

Inclusion criteria

for participants with OSA who have CPAP intolerance:

  • Symptomatic, with polysomnography (PSG) showing AASM AHI 5-60 and symptoms attributable to OSA, with greater than 75% of the apneas and hypopneas being obstructive in nature. Home sleep apnea testing (HSAT) will also be accepted, with RDI 5-60, with greater than 75% of the apneas and hypopneas being obstructive in nature.
  • Attempted nightly use for at least 2 weeks (at least 12/14 nights), with average use < 4 hours, and difficulty tolerating PAP during a titration study, with complaints of difficulty breathing with CPAP or other difficulties that are not clearly related to identifiable causes (claustrophobia, mask discomfort, untreated RLS, untreated mouth leak, poor sleep hygiene, drug use, etc.).
  • Must be able to breathe through their noses comfortably while awake.
  • Able and willing to do daily swallowing exercises (15-30 minutes per day) for a total of 14 weeks.
  • Able and willing to use a positional therapy device to avoid supine sleep and to adjust their CPAP device settings (instructions will be provided).
  • BMI between 18.5 and 35
  • Not actively undergoing bariatric treatment or planning to start bariatric treatment within the next 6 months.

Exclusion criteria

for all participants:

  • Presence of symptomatic swallowing disorders, neuromuscular disorders affecting the upper airway, or neurodegenerative disorders.
  • Co-existing sleep disorders such as narcolepsy, untreated restless legs syndrome, circadian rhythm disorders, or behavioral insomnia/poor sleep hygiene.
  • Clinically significant congenital or acquired anomalies or history of surgery on the head and neck, excluding adenotonsillectomy, turbinate reduction, and septoplasty. Participants who had a tongue tie release outside of the newborn period will be excluded, but those who had tongue tie release in the newborn period will be eligible.
  • Known complex sleep apnea or a history of conditions that are associated with the development of complex sleep apnea, such as heart failure, atrial fibrillation, a history of stroke, or opioid use.
  • Prescription or nonprescription stimulant use (excluding caffeine).
  • Substance use disorder or nightly alcohol consumption, as these significantly interfere with normal sleep.
  • Current unstable illness (such as asthma, hypertension, cancer, etc.), kidney failure with restrictions on fluid consumption, or unplanned hospitalization in the past year for an ongoing condition.
  • Risk factors for harm from expiratory strength testing and training: history of spontaneous pneumothorax, presence of CSF drain, recent trauma involving head, neck, or chest, history of recurrent epistaxis, history of esophageal surgery, active or recent hemoptysis, history of lung transplant or lung resection, eardrum rupture or any other condition of the ear, uncontrolled gastroesophageal reflux, abdominal hernia or recent hernia repair, urinary or fecal incontinence, presence of aneurysm (such as cerebral or aortic).
  • Participants with CPAP intolerance only: Latex allergy in themselves or household members (due to balloon use in exercises).
  • Allergy to Micropore paper tape (used in home sleep testing and for participants with CPAP intolerance during 2-week CPAP trial and exercise intervention).
  • Pregnancy, actively trying to get pregnant, or sexually active and not using birth control (for people of child-bearing potential).
  • Has a condition that increases the risk of developing cancer, such as BRCA1/2.
  • Does not speak English fluently.

Treatment and study plan

SLP swallowing exercises

Other

Clinical speech language pathologists will provide standard exercises based on the abnormalities seen on the modified barium swallow. Exercises are expected to include the effortful swallow, the Mendelsohn maneuver, expiratory muscle strength training with the EMST-150, supraglottic swallow, super supraglottic swallow, chin tuck against resistance isokinetic exercise, chin tuck against resistance isometric exercise, Masako maneuver, Shaker isometric head lift exercise, Shaker isokinetic head lift exercise, Falsetto high pitch glide exercise, tongue press exercise

Other names: speech language pathology exercises, SLP exercises

myofunctional exercises

Other

Participants will get a variety of exercises aimed at improving bolus formation, strengthening the seal of the soft palate with the tongue, and habituating nasal breathing. There will also be exercises aimed at stabilizing the epiglottis and strengthening the muscles supporting the lateral pharyngeal walls. Expiratory muscle strength training with the EMST-150 will also be done.

Other names: orofacial myofunctional therapy (OMT), OMT exercises

Primary outcomes

  1. Prevalence of premature spillage in participants with OSA who are CPAP intolerant vs participants who are successful nasal CPAP users or who have healthy airways

    Time frame: at the time of MBS (within 2-4 weeks of study enrollment)

    MBS images will be evaluated for premature spillage during oral bolus formation. Comparison of prevalence of premature spillage will be made between study groups.

  2. Effect of swallowing exercise intervention for CPAP intolerance

    Time frame: 3-7 months after enrollment

    The effect of a swallowing exercise intervention on CPAP intolerance will be assessed, as reflected by change in usage from the participants' own pre-treatment CPAP data.

    The results of the two exercise interventions will be pooled, as the goal is to see if swallowing exercises can improve CPAP tolerance rather than to compare therapies.

Secondary outcomes

  1. Baseline length of the oropharyngeal seal during bolus formation in the modified barium swallow study (MBS)

    Time frame: at the time of MBS (within 2-4 weeks of study enrollment)

    The length of the oropharyngeal seal during bolus formation will be measured to assess for differences between participants with healthy airways and those with OSA.

  2. Baseline breathing route during wakefulness as assessed by MBS

    Time frame: at the time of MBS (within 2-4 weeks of study enrollment)

    Breathing route (oral, oronasal, or nasal) will be determined by soft palate position during resting breathing under fluoroscopy in the modified barium swallow study. Comparison will be made between healthy airways, CPAP intolerant, and successful CPAP user groups.

  3. Baseline tongue position as observed during nasal breathing during MBS

    Time frame: at the time of MBS (within 2-4 weeks of study enrollment)

    A high or low tongue resting position during nasal breathing will be noted upon review of the MBS images. Tongue position will be compared between study groups.

  4. Baseline soft palate shape as observed during nasal breathing during MBS

    Time frame: at the time of MBS (within 2-4 weeks of study enrollment)

    Assessment of the angulation of the soft palate during nasal breathing will be performed. Results will be compared between healthy airways, CPAP intolerant, and successful CPAP user groups.

  5. Baseline assessment of Tipper- vs Dipper-type oral swallowing

    Time frame: at the time of MBS (within 2-4 weeks of study enrollment)

    The presence of Tipper-type vs Dipper-type oral swallowing will be assessed by MBS. The prevalence of the oral swallowing types in the study groups will be compared.

  6. Baseline assessment of anterior tongue strength

    Time frame: at the time of the measurement visit (within 2-4 weeks of study enrollment); participants with CPAP intolerance will have a second measurement visit at the end of the study

    Assessment of anterior tongue strength will be made using an IOPI (Iowa Oral Performance Index) system. Strength will be compared between groups.

  7. Baseline assessment of posterior tongue strength

    Time frame: at the time of the measurement visit (within 2-4 weeks of study enrollment)

    Assessment of posterior tongue strength will be made using an IOPI (Iowa Oral Performance Index) system. Strength will be compared between groups.

  8. Baseline assessment of combined lip/cheek strength

    Time frame: at the time of the measurement visit (within 2-4 weeks of study enrollment)

    Assessment of combined lip/cheek strength will be made using an IOPI (Iowa Oral Performance Index) system. Strength will be compared between groups.

  9. Baseline assessment of combined lip/cheek activation during swallowing

    Time frame: at the time of the measurement visit (within 2-4 weeks of study enrollment)

    Assessment of combined lip/cheek activation during swallowing will be made using an IOPI (Iowa Oral Performance Index) system. Extent of combined lip/cheek activation during swallowing will be compared between groups.

  10. Baseline maximum expiratory pressure

    Time frame: at the time of the measurement visit (within 2-4 weeks of study enrollment)

    Maximum expiratory pressure (MEP) will be assessed and compared between study groups.

  11. Baseline maximum inspiratory pressure via oral route

    Time frame: at the time of the measurement visit (within 2-4 weeks of study enrollment)

    Maximum inspiratory pressure by the oral route will be assessed and compared between study groups.

  12. Baseline sniff inspiratory pressure (SNIP) via nasal route

    Time frame: at the time of the measurement visit (within 2-4 weeks of study enrollment)

    Baseline maximum sniff inspiratory pressure (SNIP) by the nasal route will be assessed and compared between study groups.

  13. Baseline awake resting breathing route assessment by nasal pressure signal

    Time frame: at the time of the measurement visit (within 2-4 weeks of study enrollment)

    Awake breathing route (oral, oronasal, or nasal) will be inferred by nasal pressure signal during resting breathing. Comparison will be made between healthy airways, CPAP intolerant, and successful CPAP user groups.

  14. Baseline assessment of Mallampati score

    Time frame: at the time of the measurement visit (within 2-4 weeks of study enrollment)

    Mallampati score will be assessed by physical examination. Comparisons will be made between study groups.

  15. Baseline assessment of Friedman tongue position score

    Time frame: at the time of the measurement visit (within 2-4 weeks of study enrollment)

    Friedman tongue position score will be assessed by physical examination. Comparisons will be made between study groups.

  16. Baseline anterior tongue tie evaluation

    Time frame: at the time of the measurement visit (within 2-4 weeks of study enrollment)

    Anterior tongue tie evaluation will be made using the tongue tie assessment tool. Comparisons between groups will be made.

  17. Baseline posterior tongue tie evaluation

    Time frame: at the time of the measurement visit (within 2-4 weeks of study enrollment)

    Posterior tongue tie evaluation will be made using the tongue tie assessment tool. Comparisons between groups will be made.

  18. Baseline visual differences in swallowing

    Time frame: at the time of the measurement visit (within 2-4 weeks of study enrollment)

    Utilization of lip and cheek muscles during swallowing will be assessed visually (with videorecording). Comparisons will be made between the study groups.

  19. Baseline head tilt angle differences

    Time frame: at the time of the measurement visit (within 2-4 weeks of study enrollment)

    Head tilt angle will be measured by glasses with an attached digital level. Comparisons will be made between study groups.

  20. Baseline postural assessment

    Time frame: at the time of the measurement visit (within 2-4 weeks of study enrollment)

    Photographs will be taken with the participant standing next to a plumb line for postural assessment. Comparisons will be made between study groups.

  21. Baseline CPAP waveform differences between participants with CPAP intolerance and participants who are successful CPAP users (participants with OSA only)

    Time frame: At study enrollment (successful CPAP users) or after baseline 2-week CPAP trial (participants with CPAP intolerance), within 1 months of enrollment

    CPAP waveforms will be assessed for the presence of negative effort dependence or other differences in the airflow waveform shapes in participants with CPAP intolerance compared to participants who are successful nasal CPAP users.

  22. Baseline differences in nasal pressure signal during sleep between participants with CPAP intolerance and participants who are successful CPAP users (participants with OSA only)

    Time frame: At enrollment (if recent PSG is already available) or after completion of home sleep testing, within one month of enrollment

    Nasal pressure waveforms during sleep will be assessed for the presence of negative effort dependence or other features that may be different between participants with CPAP intolerance compared to participants who are successful nasal CPAP users, as seen in polysomnography or home sleep testing.

  23. Baseline Swallowing Disturbance Questionnaire

    Time frame: When baseline questionnaires are returned, within one month of enrollment.

    Participants will complete the Swallowing Disturbance Questionnaire. Responses will be compared between study groups.

  24. Baseline Epworth Sleepiness Scale (ESS)

    Time frame: When baseline questionnaires are returned, within one month of enrollment.

    Participants will complete the Epworth Sleepiness Scale (ESS) questionnaire. Comparisons will be made between study groups.

  25. Baseline Pittsburgh Sleep Quality Index (PSQI) questionnaire

    Time frame: When baseline questionnaires are returned, within one month of enrollment.

    Participants will complete the Pittsburgh Sleep Quality Index (PSQI) questionnaire. Comparisons will be made between study groups.

  26. Baseline Insomnia Severity Index (ISI) questionnaire

    Time frame: When baseline questionnaires are returned, within one month of enrollment.

    Participants will complete the Insomnia Severity Index (ISI) questionnaire. Comparisons will be made between study groups.

  27. Baseline Short Calgary Sleep Apnea Quality Of Life Index questionnaire

    Time frame: When baseline questionnaires are returned, within one month of enrollment.

    Participants will complete the Short Calgary Sleep Apnea Quality Of Life Index questionnaire. Comparisons will be made between study groups.

  28. Baseline Short Form Health Survey-36 questionnaire

    Time frame: When baseline questionnaires are returned, within one month of enrollment.

    Participants will complete the Short Form Health Survey-36 questionnaire. Comparisons will be made between study groups.

  29. Baseline PROMIS Sleep Disturbance short form 8b questionnaire

    Time frame: When baseline questionnaires are returned, within one month of enrollment.

    Participants will complete the PROMIS Sleep Disturbance short form 8b questionnaire. Comparisons will be made between study groups.

  30. Baseline PROMIS Sleep-related impairment short form 8a questionnaire

    Time frame: When baseline questionnaires are returned, within one month of enrollment.

    Participants will complete the PROMIS Sleep-related impairment short form 8a questionnaire. Comparisons will be made between study groups.

  31. Baseline sleep habits and swallowing and CPAP observations questionnaire

    Time frame: When baseline questionnaires are returned, within one month of enrollment.

    Participants will complete questionnaires on sleep habits and swallowing and CPAP observations. Responses will be compared between study groups.

  32. Post-intervention assessment of AHI by home sleep testing (participants with CPAP intolerance only)

    Time frame: Before the post-intervention CPAP trial or two weeks after the CPAP trial, which will be approximately 3-7 months after enrollment, depending on whether one or two courses of exercises is done

    Repeat home sleep testing will be performed after the final swallowing exercise intervention has been completed (before the CPAP trial or two weeks after the CPAP trial). Results will be compared with the participant's baseline home sleep test.

  33. Post-intervention changes in nasal airflow during sleep (participants with CPAP intolerance only)

    Time frame: Before the post-intervention CPAP trial or two weeks after the CPAP trial, which will be approximately 3-7 months after enrollment, depending on whether one or two courses of exercises is done

    Nasal pressure signal on home sleep testing will be assessed for changes in flow limitation and negative effort dependence after the intervention, and compared to the participant's pre-intervention waveforms.

  34. Post-intervention assessment of pulse oxygen nadir by home sleep testing (participants with CPAP intolerance only)

    Time frame: Before the post-intervention CPAP trial or two weeks after the CPAP trial, which will be approximately 3-7 months after enrollment, depending on whether one or two courses of exercises is done

    Repeat home sleep testing will be performed after the final swallowing exercise intervention has been completed (before the CPAP trial or two weeks after the CPAP trial). Pulse oxygen nadir will be determined and compared with the participant's baseline home sleep test.

  35. Post-intervention assessment of time with oxygen saturation less than 90% during home sleep testing (participants with CPAP intolerance only)

    Time frame: Before the post-intervention CPAP trial or two weeks after the CPAP trial, which will be approximately 3-7 months after enrollment, depending on whether one or two courses of exercises is done

    Repeat home sleep testing will be performed after the final swallowing exercise intervention has been completed (before the CPAP trial or two weeks after the CPAP trial). The time spent with oxygen saturation less than 90% will be determined and compared with the participant's baseline home sleep study.

  36. Post-intervention differences in nasal pressure signal during home sleep testing (participants with CPAP intolerance only)

    Time frame: After the post-intervention 2-week CPAP trial, 3-7 months after study enrollment

    Post-intervention nasal pressure waveforms during home sleep testing will be assessed for the presence of negative effort dependence or other changes. Results will be compared to participant's baseline results and to those of participants who are successful nasal CPAP users, as seen in polysomnography or home sleep testing.

  37. Post-intervention assessment of oral bolus formation during MBS (participants with CPAP intolerance only)

    Time frame: Within 2-4 weeks of the completion of the final swallowing exercise intervention, which will be 3-7 months after enrollment

    Repeat MBS after the swallowing exercise intervention will be done to assess for any changes in oral bolus formation/premature spillage.

  38. Post-intervention length of oropharyngeal seal during bolus formation in modified barium swallow study (MBS) (participants with CPAP intolerance only)

    Time frame: at the time of the post-intervention MBS, approximately 3-7 months after enrollment, depending on whether one or two courses of exercises is done

    The length of the oropharyngeal seal during oral bolus formation will be measured on MBS. Results will be compared to the participant's baseline MBS.

  39. Post-intervention breathing route during wakefulness by MBS (participants with CPAP intolerance only)

    Time frame: at the time of the post-intervention MBS, approximately 3-7 months after enrollment, depending on whether one or two courses of exercises is done

    Breathing route (oral, oronasal, or nasal) will be determined by soft palate position during resting breathing under fluoroscopy in the repeat modified barium swallow study, to be done after completion of the final exercise intervention. Comparison will be made to the participant's baseline results.

  40. Post-intervention tongue position as observed during nasal breathing during MBS (participants with CPAP intolerance only)

    Time frame: at the time of the post-intervention MBS, approximately 3-7 months after enrollment, depending on whether one or two courses of exercises is done

    A high or low tongue resting position during nasal breathing will be noted upon review of the MBS images. Tongue position will be compared to participant's baseline results.

  41. Post-intervention soft palate shape as observed during nasal breathing during MBS (participants with CPAP intolerance only)

    Time frame: at time of the post-intervention MBS, approximately 3-7 months after enrollment, depending on whether one or two courses of exercises is done

    Assessment of the angulation of the soft palate during nasal breathing will be performed. Results will be compared to the participant's baseline.

  42. Post-intervention assessment of Tipper- vs Dipper-type swallowing (participants with CPAP intolerance only)

    Time frame: at the time of the post-intervention MBS, approximately 3-7 months after enrollment, depending on whether one or two courses of exercises is done

    The presence of Tipper-type vs Dipper-type oral swallowing will be assessed by repeat MBS. The results will be compared to the participant's baseline.

  43. Post-intervention assessment of anterior tongue strength (participants with CPAP intolerance only)

    Time frame: at the time of the post-intervention measurement visit, approximately 3-7 months after enrollment, depending on whether one or two courses of exercises is done

    Assessment of anterior tongue strength will be made using an IOPI (Iowa Oral Performance Index) system during the post-intervention measurement visit. Strength will be compared to participant's baseline and to baseline results for the other study groups.

  44. Post-intervention assessment of posterior tongue strength (participants with CPAP intolerance only)

    Time frame: at the time of the post-intervention measurement visit, approximately 3-7 months after enrollment, depending on whether one or two courses of exercises is done

    Assessment of posterior tongue strength will be made using an IOPI (Iowa Oral Performance Index) system during the post-intervention measurement visit. Strength will be compared to participant's baseline and to baseline results for the other study groups.

  45. Post-intervention assessment of combined lip/cheek strength (participants with CPAP intolerance only)

    Time frame: at the time of the post-intervention measurement visit, approximately 3-7 months after enrollment, depending on whether one or two courses of exercises is done

    Assessment of combined lip/cheek strength will be made using an IOPI (Iowa Oral Performance Index) system during the post-intervention measurement visit. Strength will be compared to participant's baseline and to baseline results for the other study groups.

  46. Post-intervention assessment of combined lip/cheek activation during swallowing (participants with CPAP intolerance only)

    Time frame: at the time of the post-intervention measurement visit, approximately 3-7 months after enrollment, depending on whether one or two courses of exercises is done

    Repeat assessment of combined lip/cheek activation during swallowing will be made using an IOPI (Iowa Oral Performance Index) system. Extent of lip/cheek activation during swallowing will be compared to participant's baseline results and also to the baseline results of the other study groups.

  47. Post-intervention maximum expiratory pressure (participants with CPAP intolerance only)

    Time frame: at the time of the post-intervention measurement visit, approximately 3-7 months after enrollment, depending on whether one or two courses of exercises is done

    Maximum expiratory pressure (MEP) will be assessed post-intervention and compared to participant's baseline and the baseline results of the other study groups.

  48. Post-intervention maximum inspiratory pressure via oral route (participants with CPAP intolerance only)

    Time frame: at the time of the post-intervention measurement visit, approximately 3-7 months after enrollment, depending on whether one or two courses of exercises is done

    Maximum inspiratory pressure by the oral route will be assessed post-intervention. Results will be compared to participant's baseline results and to baseline results of other study groups.

  49. Post-intervention sniff inspiratory pressure (SNIP) via nasal route (participants with CPAP intolerance only)

    Time frame: at the time of the post-intervention measurement visit, approximately 3-7 months after enrollment, depending on whether one or two courses of exercises is done

    Post-intervention maximum sniff inspiratory pressure (SNIP) by the nasal route will be assessed. Results will be compared to participant's baseline values and between those of the other study groups.

  50. Post-intervention awake resting breathing route assessment by nasal pressure signal (participants with CPAP intolerance only)

    Time frame: at the time of the post-intervention measurement visit, approximately 3-7 months after enrollment, depending on whether one or two courses of exercises is done

    Post-intervention awake breathing route (oral, oronasal, or nasal) will be determined by nasal pressure signal during resting breathing. Comparison will be made to participant's baseline results and to those of the other study groups.

  51. Post-intervention assessment of Mallampati score (participants with CPAP intolerance only)

    Time frame: at the time of the post-intervention measurement visit, approximately 3-7 months after enrollment, depending on whether one or two courses of exercises is done

    Post-intervention Mallampati score will be assessed by physical examination. Comparisons will be made to participant's baseline value and to the Mallampati scores of the other study groups.

  52. Post-intervention assessment of Friedman tongue position score (participants with CPAP intolerance only)

    Time frame: at the time of the post-intervention measurement visit, approximately 3-7 months after enrollment, depending on whether one or two courses of exercises is done

    Post-intervention Friedman tongue position score will be assessed by physical examination. Comparisons will be made to participant's baseline score and also to scores of the other study groups.

  53. Post-intervention anterior tongue tie evaluation (participants with CPAP intolerance only)

    Time frame: at the time of the post-intervention measurement visit, approximately 3-7 months after enrollment, depending on whether one or two courses of exercises is done

    Repeat anterior tongue tie evaluation will be made using the tongue tie assessment tool. Comparisons to participant's baseline results and the results of other study groups will be made.

  54. Post-intervention posterior tongue tie evaluation (participants with CPAP intolerance only)

    Time frame: at the time of the post-intervention measurement visit, approximately 3-7 months after enrollment, depending on whether one or two courses of exercises is done

    Post-intervention posterior tongue tie evaluation will be made using the tongue tie assessment tool. Result will be compared to participant's baseline result and to the results of the other study groups.

  55. Post-intervention visual differences in swallowing (participants with CPAP intolerance only)

    Time frame: at the time of the post-intervention measurement visit, approximately 3-7 months after enrollment, depending on whether one or two courses of exercises is done

    Post-intervention utilization of lip and cheek muscles during swallowing will be assessed visually (with videorecording). Comparisons will be made to the participant's baseline results and to the results of the other study groups.

  56. Post-intervention head tilt angle differences (participants with CPAP intolerance only)

    Time frame: at the time of the post-intervention measurement visit, approximately 3-7 months after enrollment, depending on whether one or two courses of exercises is done

    Post-intervention head tilt angle will be measured by glasses with an attached digital level. Comparisons will be made to participant's baseline value and to those of the other study groups.

  57. Post-intervention postural assessment (participants with CPAP intolerance only)

    Time frame: at the time of the post-intervention measurement visit, approximately 3-7 months after enrollment, depending on whether one or two courses of exercises is done

    Post-intervention photographs will be taken with the participant standing next to a plumb line for postural assessment. Comparisons will be made to participant's baseline results and to those of the other study groups.

  58. Post-intervention CPAP waveform differences (participants with CPAP intolerance only)

    Time frame: After the post-intervention 2-week CPAP trial, 3-7 months after study enrollment.

    After the final 2-week CPAP trial, CPAP waveforms will be obtained from the CPAP data chip and assessed for the presence of negative effort dependence or other differences in the airflow waveform shapes. Results will be compared to participant's pre-intervention results and those of participants who are successful nasal CPAP users.

  59. Post-intervention CPAP residual AHI (participants with CPAP intolerance only)

    Time frame: After the post-intervention 2-week CPAP trial, 3-7 months after study enrollment.

    Residual AHI will be collected from the CPAP data chip after 2-week CPAP trial at the end of the swallowing exercise intervention. Results will be compared to participant's pre-intervention results and those of participants who are successful nasal CPAP users.

  60. Post-intervention number of nightly CPAP mask removals (participants with CPAP intolerance only)

    Time frame: After the post-intervention 2-week CPAP trial, 3-7 months after study enrollment.

    The number of nightly CPAP mask removals will be collected from the CPAP data chip after 2-week CPAP trial at the end of the swallowing exercise intervention. Results will be compared to participant's pre-intervention results and those of participants who are successful nasal CPAP users.

  61. Post-intervention Swallowing Disturbance Questionnaire (participants with CPAP intolerance only)

    Time frame: When the post-intervention questionnaires are returned, which will be approximately 3-7 months after enrollment, depending on whether one or two courses of exercises is done

    Participants will complete a second Swallowing Disturbance Questionnaire after completing the final exercise intervention. Responses will be compared to their baseline questionnaire.

  62. Post-intervention Epworth Sleepiness Scale (ESS) (participants with CPAP intolerance only)

    Time frame: When the post-intervention questionnaires are returned, which will be approximately 3-7 months after enrollment, depending on whether one or two courses of exercises is done

    Participants will complete a second Epworth Sleepiness Scale (ESS) questionnaire after completing the final exercise intervention. Comparison will be made to the participant's baseline results.

  63. Post-intervention Pittsburgh Sleep Quality Index (PSQI) questionnaire (participants with CPAP intolerance only)

    Time frame: When the post-intervention questionnaires are returned, which will be approximately 3-7 months after enrollment, depending on whether one or two courses of exercises is done

    Participants will complete a second Pittsburgh Sleep Quality Index (PSQI) questionnaire after completing the final exercise intervention. Comparison will be made to participant's baseline results.

  64. Post-intervention Insomnia Severity Index (ISI) questionnaire (participants with CPAP intolerance only)

    Time frame: When the post-intervention questionnaires are returned, which will be approximately 3-7 months after enrollment, depending on whether one or two courses of exercises is done

    Participants will complete a second Insomnia Severity Index (ISI) questionnaire after completing the final exercise intervention. Comparison will be made to participant's baseline results.

  65. Post-intervention Short Calgary Sleep Apnea Quality Of Life Index questionnaire (participants with CPAP intolerance only)

    Time frame: When the post-intervention questionnaires are returned, which will be approximately 3-7 months after enrollment, depending on whether one or two courses of exercises is done

    Participants will complete a second Short Calgary Sleep Apnea Quality Of Life Index questionnaire after completing the final exercise intervention. Comparison will be made to participant's baseline results.

  66. Post-intervention Short Form Health Survey-36 questionnaire (participants with CPAP intolerance only)

    Time frame: When the post-intervention questionnaires are returned, which will be approximately 3-7 months after enrollment, depending on whether one or two courses of exercises is done

    Participants with CPAP intolerance will complete a second Short Form Health Survey-36 questionnaire after completion of the exercise intervention(s). Comparisons will be made to their responses on the baseline questionnaire.

  67. Post-intervention PROMIS Sleep Disturbance short form 8b questionnaire (participants with CPAP intolerance only)

    Time frame: When the post-intervention questionnaires are returned, which will be approximately 3-7 months after enrollment, depending on whether one or two courses of exercises is done

    Participants will complete a second PROMIS Sleep Disturbance short form 8b questionnaire after completing the final exercise intervention. Comparison will be made to participant's baseline results.

  68. Post-intervention PROMIS Sleep-related impairment short form 8a questionnaire (participants with CPAP intolerance only)

    Time frame: When the post-intervention questionnaires are returned, which will be approximately 3-7 months after enrollment, depending on whether one or two courses of exercises is done

    Participants will complete a second PROMIS Sleep-related impairment short form 8a after completing the final exercise intervention. Comparison will be made to participant's baseline results.

  69. Post-intervention sleep habits and swallowing and CPAP observations questionnaire (participants with CPAP intolerance only)

    Time frame: When the post-intervention questionnaires are returned, which will be approximately 3-7 months after enrollment, depending on whether one or two courses of exercises is done

    Participants will complete repeat questionnaires on sleep habits and swallowing and CPAP observations after completing the final exercise intervention. Comparison will be made to participant's baseline results.

Other outcomes

  1. Long term outcome of swallowing exercise intervention on average nightly hours of CPAP use (participants with CPAP intolerance only)

    Time frame: 3-15 months after completion of the final exercise intervention (depending on whether participant will need a CPAP device)

    Assess long-term impact of goal-oriented oromuscular rehabilitation in OSA participants with CPAP intolerance by following up on average nightly hours of CPAP use with CPAP compliance downloads and phone follow-up, to be done 3, 6, and 12 months after the end of the final CPAP trial.

Sponsors and collaborators

Lead sponsor

Denise Dewald

Other

Collaborators

  • American Academy of Sleep Medicine
  • Case Western Reserve University
  • MetroHealth Medical Center

Registry information

Official study title

Swallowing in Obstructive Sleep Apnea (OSA) & Continuous Positive Airway Pressure (CPAP) Intolerance

Acronym: SLP-PAP

Important dates

Study start
2025
Primary completion
2026
Study completion
2028
First posted
Jan 22, 2025
Registry last updated
Mar 11, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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