Actively Recruiting
Home-based Under Mattress Monitor for OSA
Led by Isabel Moreno Hay · Updated on 2026-02-03
70
Participants Needed
1
Research Sites
59 weeks
Total Duration
On this page
Sponsors
I
Isabel Moreno Hay
Lead Sponsor
A
American Academy of Dental Sleep Medicine
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
Home-based Under Mattress Monitor for OSA
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosis of obstructive sleep apnea confirmed by a sleep study scored by a sleep physician
- Willingness to attend the Orofacial Pain clinic every two weeks during MAD titration
- Consent to participate in the study
You will not qualify if you...
- Diagnosis of central or mixed sleep apnea
- Neurocognitive disease
- Current treatment with positive airway pressure (PAP) therapy
- Allergy to the mandibular advancement device material (Polyamide 12)
- Active dental decay, ill-fitting dental restorations, or unfavorable crown to root ratio
- Inadequate English language understanding
- Difficulty inserting or removing the MAD
- Unable to tolerate digital dental impressions
- Other diagnosed sleep disorders such as narcolepsy, restless leg syndrome, or REM sleep behavior disorder
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
University of Kentucky
Lexington, Kentucky, United States, 40506
Actively Recruiting
Research Team
S
Sumia Alyousef, BDS
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
DIAGNOSTIC
Number of Arms
1
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