Home-based Under Mattress Monitor for OSA

Conditions

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

Eligibility Criteria

Sex

ALL

Age

18 Years - 80 Years

Healthy Volunteers

Not accepted

Interventions

• Under-mattress monitor — DEVICE
  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
• level 3 Home Sleep Apnea Test — DEVICE
  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.
• Mandibular Advancement Device (MAD) — DEVICE
  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

Study Details

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.

Key Dates

Start date

Jan 7, 2026

Status verified

Feb 2026

Primary completion

Mar 31, 2027

Completion

Mar 31, 2027

Study Design

Enrollment

70 participants (estimated)

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

DIAGNOSTIC

Arms

• Experimental: Panthera DSAD mandibular advancement device users
  Participants of the study that have been referred to the Orofacial Pain Clinic by their sleep physician for the management of their obstructive sleep apnea with a mandibular advancement device.

Primary Outcome Measure

Change in apnea-hypopnea index (AHI). [ Time Frame: Baseline and post-intervention (approximately 12 weeks) ]

Central Contacts

• Sumia Alyousef, BDS
  (859) 323-3440
  [email protected]

Locations (1)

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