Home under-mattress monitor to guide mandibular advancement therapy for sleep apnea

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.