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NCT Number: NCT07186725

Home-based Under Mattress Monitor for OSA

The aim of the study is to evaluate the effectiveness of the under-mattress monitoring device to aid in the titration process of a mandibular advancement device (MAD) for the management of obstructive sleep apnea (OSA). A secondary aim is to evaluate changes in subjective OSA symptoms and patient's satisfaction with MAD. A third aim is to analyze if there are differences between the sleep parameters recorded by the under-mattress monitor between responders and non-responders to MAD therapy.

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Key information

Conditions

Obstructive Sleep Apnea (OSAS) Apnea Dyssomnias Nervous System Diseases Obstructive Sleep Apnea (SAOS) Respiration Disorders Respiratory Tract Diseases Sleep Apnea Syndromes Sleep Apnea, Obstructive Sleep Disorders, Intrinsic Sleep Wake Disorders

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Kentucky

Lexington, Kentucky, 40506, United States

Location status: Recruiting

Location contact

Sumia Alyousef, BDS

CONTACT

[email protected]

8593235500

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Diagnosis of Obstructive Sleep Apnea demonstrated with a sleep study polysomnography or home sleep study (PSG or HSAT), manually scored by a sleep physician according to the 2017 American Academy of Sleep medicine scoring guidelines.
  • Willingness to commute to the OFP clinic every 2 weeks during MAD titration period.
  • Consent to partake in the study.

Exclusion criteria

  • Diagnosis of central or mixed sleep apnea.
  • Neurocognitive disease.
  • Concomitant therapy with PAP therapy.
  • Allergic to the appliance material (Polyamide 12).
  • Presence of active dental decay, ill-fitting dental restorations, or crown to root ratio unfavorable.
  • Inadequate English language comprehension.
  • Lack of coordination or dexterity to insert/remove the MAD intraorally.
  • Inability to tolerate digital dental impressions.
  • Patients with concomitant diagnosed sleep disorders, including narcolepsy, restless leg syndrome, rapid eye movement sleep behavior disorder).

Treatment and study plan

Under-mattress monitor

Device

the under-mattress monitor will be used in conjunction with the Alice NightOne at the beginning and end of the study, in addition, the under-mattress monitor will be used daily during sleep with the intraoral device in situ

Other names: Sleeptracker-AI

level 3 Home Sleep Apnea Test

Device

Home sleep apnea test with Alice NightOne will be used for one day during sleep at the beginning and end of the study in conjunction with the Sleeptracker AI and the intraoral device.

Other names: Alice NightOne

Mandibular advancement device (MAD)

Device

CAD-CAM, US Food and Drug Administration (FDA)-approved MAD, duo-bloc, customized, titratable sleep appliance. Participants will return every 2 weeks to the Orofacial Pain (OFP) clinic to progressively titrate the MAD advancement as needed until the under-mattress monitor scores an AHI < 5

Other names: D-SADTM Panthera Dental

Primary outcomes

  1. Change in apnea-hypopnea index (AHI).

    Time frame: Baseline and post-intervention (approximately 12 weeks)

    Number of apneas and hypopneas per hour of sleep which is an indicator of severity of sleep apnea, (5< normal, 5-15 Mild, 15-30 moderate, <30 severe)

  2. Change in minimum oxygen desaturation level

    Time frame: Baseline and post-intervention (approximately 12 weeks)

    The minimum O2 level percentage during treatment

Secondary outcomes

  1. Change in Epworth Sleepiness Scale

    Time frame: Baseline and post-intervention (approximately 12 weeks)

    This scale measures daytime sleepiness. Scores range from 0-24. Higher scores indicate more severe daytime sleepiness.

  2. Change in Quality of Life Scale

    Time frame: Baseline and post-intervention (approximately 12 weeks)

    Quality of life (15D questionnaire) with 15 question items with 5 alternatives in each. The scores range between 15 to 75 with 15 the best and 75 the worst quality of life.

  3. Change in Fatigue Assessment Scale

    Time frame: Baseline and post-intervention (approximately 12 weeks)

    The scale consists of 10 questions about the characteristics of fatigue in the current daily routine. The scale scores range from 10-50, with higher score indicating higher level of fatigue.

  4. Change in Pittsburgh Sleep Quality Index (PSQI)

    Time frame: Baseline and post-intervention (approximately 12 weeks)

    The PSQI is a 19-item questionnaire that includes seven areas of sleep quality and patterns in adults over the last month including the following components: subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, SDs, use of sleeping medications, and daytime dysfunction. Each item in the scale is scored from 0 to 3 scale (0 = no difficulty; 3 = severe difficulty). The scores are added to yield a global score ranging from 0 to 21 (0 = no difficulty; 21 = severe difficulties in all areas). A high total scale score indicates poor sleep quality.

  5. Change in Snore Outcomes Survey (SOS)

    Time frame: Baseline and post-intervention (approximately 12 weeks)

    SOS consists of eight items related to the frequency, duration, severity, and consequences associated with sleep-disordered breathing and specifically snoring. Respondents use several Likert-type scales to answer questions regarding their snoring, with lower scores indicating more acute problems with SDB. Scores are normalized on a scale from 0 to 100.

  6. Short Assessment of Patient Satisfaction

    Time frame: Post Intervention, approximately week 12

    Patient satisfaction with MAD will be measured by a 7-item questionnaire scored on a Likert type scale. Scores range from 7 to 35. Higher scores equate to greater satisfaction.

Study contacts

Contact information is provided by the study sponsor or research team.

Sumia Alyousef, BDS

CONTACT

[email protected]

(859) 323-3440

Sponsors and collaborators

Lead sponsor

Isabel Moreno Hay

Other

Collaborators

  • American Academy of Dental Sleep Medicine

Registry information

Official study title

Home-Based Under-Mattress Monitoring Device to Estimate Mandibular Advancement in Oral Appliance Therapy for Obstructive Sleep Apnea

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Sep 22, 2025
Registry last updated
Feb 3, 2026

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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