Home-based Under Mattress Monitor for OSA

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.

Conditions

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

Interventions

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

Sponsors & Collaborators

• American Academy of Dental Sleep Medicine

  collaborator UNKNOWN

• Isabel Moreno Hay

  lead OTHER

Principal Investigators

• Isabel Moreno Hay, DDS, PhD · University of Kentucky

Study Design

Allocation

NA

Purpose

DIAGNOSTIC

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Max Age

80 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2026-01-07

Primary Completion

2027-03-31

Completion

2027-03-31

FDA Device

Yes

Countries

• United States

Study Locations