Service des pathologies du sommeil, Pitié-Salpêtrière hospital
Paris, 75013, France
Not Yet Recruiting
NCT Number: NCT05911971
Upper Airway Reeducation in Moderate Obstructive Sleep Apnea Syndrome
The aim of this study is to evaluate the effectiveness of a specific reeducation performed by speech therapists in moderate obstructive sleep apnea syndrome, as an alternative to the continuous Positive Anyway Pressure (CPAP) and the mandibular advancement device.
Not Yet Recruiting
Trial opening soon.
Get NotifiedKey information
Conditions
Age range
18 year and older
Sex eligibility
All sexes
Study type
Interventional
Phase
Phase 3
Primary location
About this study
Patients will be recruited in the sleep pathology department, following a sleep consultation and/or a polysomnography. They will be randomized between 2 reeducation groups (specific reeducation or sham reeducation) and will have to perform their respective exercises during 3 months. Only one of the 2 reeducations is expected to be effective. To limit performance and measure bias, patients will not be aware of the content of the reeducation in the other group (participants partially blinded of study hypothesis) and therefore these are not described in detail here. The initial clinical assessment will be repeated at 3 and 6 months, by assessors blinded to the reeducation arm, in order to evaluate the short and medium term effectiveness on the the Apnea-Hypopnea Index (AHI) and other outcomes.
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
- Male or female, 18 years old minimum
- Diagnosis of moderate OSAS: AHI ≥ 15 events/h and < 30 events/h at PSG M0
- BMI < 35 kg/m2
Exclusion criteria
- MoCA < 26 (Montreal Cognitive Assessment)
- Craniofacial malformations
- Regular use of hypnotic medications
- Untreated hypothyroidism
- Stroke history
- Cardiac insufficiency
- Severe uncontrolled coronary heart disease
- Severe obstructive nasal disease
- Patients with indication for CPAP in first intention
- Pregnant or breastfeeding woman
- Current participation in another interventional research in OSA
- No affiliation to a social security system or legal beneficiary (except AME,Aide médicale d'état)
- Absence of free, informed, written consent
- Contraindications for TMS: intracranial metallic implant, pacemaker and/or recent or severe cardiac disease, epilepsy, vascular, traumatic, tumor, infectious or metabolic brain lesions, severe alcoholism
- Protected adult under guardianship or curatorship
Treatment and study plan
Experimental
Otherspecific reeducation (not detailed to maintain blinding of participants)
Sham Comparator
Othersham reeducation (not detailed to maintain blinding of participants)
Primary outcomes
-
Change in apnea-hypopnea index (AHI)
Time frame: between 0 and 3 months after randomization
Apnea-hypopnea index (AHI) is the number of apnoeas or hypopnoeas per hour of sleep, measured by polysomnography during a minimum 6-hour night of inpatient sleep. Polysomnograms will be interpreted by a blinded somnologist.
Secondary outcomes
-
Change of the Apnea-Hypopnea Index (AHI)
Time frame: between 0 and 6 months after randomization
Apnea-hypopnea index (AHI) is the number of apnoeas or hypopnoeas per hour of sleep, measured by polysomnography during a minimum 6-hour night of inpatient sleep. Polysomnograms will be interpreted by a blinded somnologist.
-
Change of the MBLF(Bucco-Linguo-Facial Motor Function) score
Time frame: between 0 and 3 months and between 0 and 6 months after randomization
Quantitative evaluation of the patient's lingual mobility by the speech therapist. The test consists of the execution of 13 lingual praxias rated from 0 (no contraction) to 3 (normal contraction), with a total score from 0 to 39
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Change of the lingual strength
Time frame: between 0 and 3 months and between 0 and 6 months after randomization
measured by collecting the maximum pressure in kPa with an tongueometer.
-
Change of lingual endurance
Time frame: between 0 and 3 months and between 0 and 6 months after randomization
Following the same principle as lingual strength, lingual endurance (inversely proportional to fatigability) is measured with a tongueometer by quantifying the duration during which the patient can maintain 50% of his maximum pressure. The target value is then set to 50% of the patient's maximum pressure and the duration (in seconds)
-
Change of the size of the genioglossus representation in cm² within the motor cortex
Time frame: between 0 and 3 months after randomization
by collecting motor evoked potentials of the genioglossus in response to transcranial magnetic stimulation (TMS) applied to the anterolateral region of the right vertex between 0 and 3 months.
-
Change of quality of life on the SF-36
Time frame: between 0 and 3 months and between 0 and 6 months after randomization
Quality of life will be studied by the SF-36 generalist questionnaire completed by the patient. 36 items divided into 9 dimensions: physical activity, limitations due to physical condition, physical pain, perceived health, vitality, life and relationships with others, psychological health, limitations due to psychological condition, evolution of perceived health. Score from 0 (minimum subjective health) to 100 (maximum subjective health).
-
Change of sleep quality on the Pittsburgh Sleep Quality Index
Time frame: between 0 and 3 months and between 0 and 6 months after randomization
Sleep quality will be studied by the Pittsburgh Sleep Quality Index completed by the patient.19 questions are divided into 7 composite scores (subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, medication use, daytime dysfunctions) ranging from 0 (no difficulty) to 3 (severe difficulty). The global score is calculated by adding the 7 composite scores, the score obtained ranging from 0 to 21. The quality of sleep is investigated over the previous month.
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Change of daytime drowsiness on the Epworth Drowsiness Scale
Time frame: between 0 and 3 months and between 0 and 6 months after randomization
Daytime drowsiness will be studied by the Epworth Drowsiness Scale completed by the patient. 8 items rated from 0 (no chance of drowsiness) to 3 (systematic drowsiness), total score from 0 to 24. A score greater than or equal to 11 corresponds to daytime sleepiness.
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Presence of subjective symptoms , each taken independently
Time frame: At 3 months and 6 months after randomization
subjective evaluation by the patient following questions:snoring every night or so (yes/no), high intensity of snoring (heard through a door or complaint from the entourage (yes/no),nocturia (yes/no) if yes frequency of episodes, morning headaches (yes/no),dry mouth at night or upon waking (yes/no),impression of non-restorative sleep (yes/no),bad sleep (yes/no), if yes, number of awakenings per nigh, fatigue (yes/no), daytime sleepiness (yes/no),impatience in the legs (yes/no),nightmares (yes/no), other symptoms (yes/no)
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Change of the cervical circumference measurement (at the level of the cricoid)
Time frame: between 0 and 3 months and between 0 and 6 months after randomization
in cm, using a tape measure
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Change of the respiratory sensation sitting at rest
Time frame: between 0 and 3 months and between 0 and 6 months after randomization
Using a visual analogue scale, consisting of a 10 cm plastic ruler graduated in mm presented horizontally. The side presented to the patient has a straight non graduated line, the left end of which corresponds to "no respiratory discomfort" and the right end to "intolerable respiratory discomfort".On the other side, there are millimetre graduations only visible to speech therapist. The position of the cursor chosen by the patient allows to read the intensity of the respiratory discomfort, which is measured in mm
-
Change of change in respiratory sensation between sitting and full decubitus
Time frame: between 0 and 3 months and between 0 and 6 months after randomization
after the measurement of the respiratory sensation while sitting at rest, the patient is put in complete decubitus and the change of his respiratory discomfort between these 2 positions is measured. This change is collected using a visual analog scale, consisting of a 10 cm plastic ruler graduated in mm presented horizontally. The side presented to the patient has a straight, non-scaled line with "maximum aggravation" at the left end to "maximum improvement" at the right end, with a central marker to indicate "no change". On the other side, there are millimeter graduations only visible to speech therapist. The position of the cursor chosen by the patient allows to read the intensity of the respiratory discomfort, the results are expressed as a percentage of the full scale, the latter being defined as the distance between the central marker and one of the extremities, with a "+" sign for improvement and a "-" sign for worsening which is measured in mm.
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Change of sleep latency
Time frame: between 0 and 3 months and between 0 and 6 months after randomization
measured in minutes, during polysomnography in a minimum 6-hour night of inpatient sleep
-
Change of N3 latency
Time frame: between 0 and 3 months and between 0 and 6 months after randomization
measured in minutes, during polysomnography in a minimum 6-hour night of inpatient sleep
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Change of the paradoxical sleep latency
Time frame: between 0 and 3 months and between 0 and 6 months after randomization
measured in minutes, during polysomnography in a minimum 6-hour night of inpatient sleep
-
change of sleep efficiency
Time frame: between 0 and 3 months and between 0 and 6 months after randomization
calculated as total sleep time (TST) versus time from sleep to wakefulness (TWA), during polysomnography in a minimum 6-hour night of inpatient sleep
-
Change of the total sleep time (TST)
Time frame: between 0 and 3 months and between 0 and 6 months after randomization
measured in minutes, during polysomnography in a minimum 6-hour night of inpatient sleep
-
Change of the length of the N1
Time frame: between 0 and 3 months and between 0 and 6 months after randomization
measured in minutes, during polysomnography in a minimum 6-hour night of inpatient sleep
-
Change of the percentage (related to the TST) of the N1
Time frame: between 0 and 3 months and between 0 and 6 months after randomization
measured in percentage of TST, during polysomnography in a minimum 6-hour night of inpatient sleep
-
Change of the length of the N2
Time frame: between 0 and 3 months and between 0 and 6 months after randomization
measured in minutes, during polysomnography in a minimum 6-hour night of inpatient sleep
-
Change of the percentage (related to the TST) of the N2
Time frame: between 0 and 3 months and between 0 and 6 months after randomization
measured in percentage of TST, during polysomnography in a minimum 6-hour night of inpatient sleep
-
Change of the length of the N3
Time frame: between 0 and 3 months and between 0 and 6 months after randomization
measured in minutes, during polysomnography in a minimum 6-hour night of inpatient sleep
-
Change of the percentage (related to the TST) of the N3
Time frame: between 0 and 3 months and between 0 and 6 months after randomization
measured in percentage of TST, during polysomnography in a minimum 6-hour night of inpatient sleep
-
Change of the length of paradoxical sleep
Time frame: between 0 and 3 months and between 0 and 6 months after randomization
measured in minutes, during polysomnography in a minimum 6-hour night of inpatient sleep
-
Change of the percentage (related to the TST) of paradoxical sleep
Time frame: between 0 and 3 months and between 0 and 6 months after randomization
measured in percentage of TST, during polysomnography in a minimum 6-hour night of inpatient sleep
-
Change of the length of intrasleep vigil
Time frame: between 0 and 3 months and between 0 and 6 months after randomization
measured in minutes, during polysomnography in a minimum 6-hour night of inpatient sleep
-
Change of the percentage (related to the TST) of intrasleep vigil
Time frame: between 0 and 3 months and between 0 and 6 months after randomization
measured in percentage of TST, during polysomnography in a minimum 6-hour night of inpatient sleep
-
Change of the index of micro-awakenings
Time frame: between 0 and 3 months and between 0 and 6 months after randomization
Is the number of micro-awakenings per hour of sleep, measured by polysomnography during a minimum 6-hour night of inpatient sleep.
-
Change of the index of micro-awakenings of respiratory origin
Time frame: between 0 and 3 months and between 0 and 6 months after randomization
Is the number of micro-awakenings of respiratory origin per hour of sleep, measured by polysomnography during a minimum 6-hour night of inpatient sleep.
-
Change of the number of periodic leg movements
Time frame: between 0 and 3 months and between 0 and 6 months after randomization
Is the number of periodic leg movements per hour of sleep, measured by polysomnography during a minimum 6-hour night of inpatient sleep.
-
Change of number of sleep cycles
Time frame: between 0 and 3 months and between 0 and 6 months after randomization
Is the number of sleep cycle, measured by polysomnography during a minimum 6-hour night of inpatient sleep.
-
Compliance with treatment
Time frame: at 3 months
declared by the patient via the logbook given to the patient at the initial assessment. After each exercises session, the patient will have to complete the day, indicate the time spent and any difficulties encountered. Telephone follow-up of compliance will be carried out by the speech therapist or the clinical study technician every month. Compliance will be evaluated by the percentage of days when the patient will have declared to have carried out exercises for a duration higher than 50% of the theoretical duration of the exercises session
Study contacts
Contact information is provided by the study sponsor or research team.
Sponsors and collaborators
Lead sponsor
Assistance Publique - Hôpitaux de Paris
Other
Registry information
Official study title
Specific Upper Airway Reeducation in Moderate Obstructive Sleep Apnea Syndrome: a Randomized Controlled Trial
Acronym: SAOSGENIO
Important dates
- Study start
- 2023
- Primary completion
- 2026
- Study completion
- 2026
- First posted
- Jun 22, 2023
- Registry last updated
- Jun 22, 2023
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.