Home-based Under Mattress Monitor for OSA
Eligible age
18–80 yrs
Accepts
All genders
Locations
1 state
Healthy volunteers
No
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About this study
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.
Sponsor: Isabel Moreno Hay
You may qualify if…
- ✓ 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.
You may not qualify if…
- ✕ 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.
Where it's recruiting
Lexington
Source: ClinicalTrials.gov · NCT07186725 · last updated 2026-02-03