Home under-mattress monitor to guide mandibular advancement therapy for sleep apnea
Home-Based Under-Mattress Monitoring Device to Estimate Mandibular Advancement in Oral Appliance Therapy for Obstructive Sleep Apnea
This study will test whether a home under-mattress monitor can help set and fine-tune a mandibular advancement device for people with obstructive sleep apnea.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 70 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | University of Kentucky Academic / other |
| Locations | 1 site (Lexington, Kentucky) |
| Trial ID | NCT07186725 on ClinicalTrials.gov |
What this trial studies
This interventional study uses an under-mattress monitoring device alongside level 3 home sleep apnea testing to guide titration of a mandibular advancement device (MAD). Participants diagnosed with obstructive sleep apnea will attend biweekly clinic visits during the MAD titration period while home devices collect sleep parameters. The study will compare symptom changes, patient satisfaction, and objective sleep measures between responders and non-responders to MAD therapy. Data will be collected at a single center (University of Kentucky) and analyzed to determine whether the under-mattress monitor improves titration and outcomes.
Who should consider this trial
Good fit: Ideal candidates are adults with a prior PSG or HSAT diagnosis of obstructive sleep apnea who can attend biweekly clinic visits, tolerate a MAD and digital dental impressions, and are not using PAP therapy.
Not a fit: Patients with central or mixed sleep apnea, active dental problems or allergies to the appliance material, those already on PAP therapy, or those unable to use the MAD are unlikely to benefit.
Why it matters
Potential benefit: If successful, the device could provide objective home feedback to optimize MAD settings and improve apnea control and comfort.
How similar studies have performed: Mandibular advancement devices and home sleep testing have prior evidence for mild-to-moderate OSA, but using an under-mattress monitor specifically to guide MAD titration is relatively novel with limited direct prior data.
Eligibility criteria
Show full inclusion / exclusion criteria
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).
Where this trial is running
Lexington, Kentucky
- University of Kentucky — Lexington, Kentucky, United States (Recruiting)
Study contacts
- Principal investigator: Isabel Moreno Hay, DDS, PhD — University of Kentucky
- Study coordinator: Sumia Alyousef, BDS
- Email: Sumia.Alyousef@uky.edu
- Phone: (859) 323-3440
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.