RecruitingNot ApplicableNCT07186725

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

Sponsor

Isabel Moreno Hay

Enrollment

70 participants

Start Date

Jan 7, 2026

Study Type

INTERVENTIONAL

Conditions

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

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

Min Age: 18 YearsMax Age: 80 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying Mandibular Advancement Device (MAD), a medical device called Under-mattress monitor, and others for people with obstructive sleep apnea (osas) and obstructive sleep apnea (saos). The study is currently recruiting participants at 1 location. People eligible for this study include aged 18 Years to 80 Years.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEUnder-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

DEVICElevel 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.

DEVICEMandibular 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

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NCT07186725

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