Home-based Under Mattress Monitor for OSA

This study is looking at how well an under-mattress monitor, called Sleeptracker AI, can help adjust a special mouthguard (Mandibular Advancement Device or MAD) for people with Obstructive Sleep Apnea (OSA). OSA is a condition where breathing repeatedly stops and starts during sleep. The study will also see if the under-mattress monitor can tell the difference between people who respond well to the MAD and those who don't. You can join if you are between 18 and 80 years old, have a diagnosed case of OSA, and are willing to visit the clinic every two weeks while your MAD is being adjusted. The main goal is to see how much your apnea-hypopnea index (AHI), a measure of breathing disruptions during sleep, and your lowest oxygen levels change after about 12 weeks.

Study design
This is an interventional study planning to enroll 70 participants. It is not specified if it is randomized or blinded.
What's involved
You will use an under-mattress monitor daily and a home sleep apnea test at the beginning and end of the study. You will also need to visit the Orofacial Pain (OFP) clinic every two weeks to adjust your Mandibular Advancement Device (MAD).
Compensation
Not stated in the trial record.
Follow-up
Your progress will be measured at baseline and again approximately 12 weeks after the intervention begins.

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NCT07186725

Home-based Under Mattress Monitor for OSA

Recruiting
NAAges 18–80InterventionalDiagnostic
Isabel Moreno Hay
~70 participants
Updated 2026-02-03 on ClinicalTrials.gov
What's tested:Under-mattress monitorlevel 3 Home Sleep Apnea TestMandibular Advancement Device (MAD)

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Change in apnea-hypopnea index (AHI).
Measured over Baseline and post-intervention (approximately 12 weeks)
+1 more outcome measured
Obstructive Sleep Apnea (OSAS)
Obstructive Sleep Apnea (SAOS)
1 sites across 1 states
Kentucky1
  • Isabel Moreno Hay, DDS, PhD · PRINCIPAL_INVESTIGATOR · University of Kentucky

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Eligibility criteria

Inclusion

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

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

  • Change in minimum oxygen desaturation levelBaseline and post-intervention (approximately 12 weeks)

    The minimum O2 level percentage during treatment