Back to Trials
NCT07186725NARecruiting

Home-based Under Mattress Monitor for OSA

Isabel Moreno Hay

Start Date

1/7/2026

Completion Date

3/1/2027

Summary

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.

Eligibility Criteria

Age Range: 18 years to 80 years

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).

Interventions

DEVICE

Under-mattress monitor

DEVICE

level 3 Home Sleep Apnea Test

DEVICE

Mandibular Advancement Device (MAD)

Interested in This Trial?

Contact the trial locations directly using the information below to learn more about enrollment.

Expressing interest lets you review the study and consent before we connect you with the research site.

Conditions

Obstructive Sleep Apnea (OSAS)Obstructive Sleep Apnea (SAOS)

Locations

University of Kentucky

Lexington, Kentucky 40506

United States