RECRUITINGINTERVENTIONAL

Home-based Under Mattress Monitor for OSA

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

About This Trial

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.

Who May Be Eligible (Plain English)

Who May Qualify: - 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. Who Should NOT Join This Trial: - 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). Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language

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).

Treatments Being Tested

DEVICE

Under-mattress monitor

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

DEVICE

level 3 Home Sleep Apnea Test

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.

DEVICE

Mandibular Advancement Device (MAD)

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

Locations (1)

University of Kentucky

Lexington, Kentucky, United States