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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

Who can join

Ages 18 to 80 · All sexes

Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.
* Patients with concomitant diagnosed sleep disorders, including narcolepsy, restless leg syndrome, rapid eye movement sleep behavior disorder).

About the 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.

What is being tested

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

Sponsor: Isabel Moreno Hay · Participants: 70 · Started: Jan 7, 2026

Contact the study team

• Sumia Alyousef, BDS · Phone: (859) 323-3440

Official record on ClinicalTrials.gov — NCT07186725

Locations in the U.S.

Conditions

• Obstructive Sleep Apnea
• Sleep Apnea

From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.