NCT07186725NARecruiting
Home-based Under Mattress Monitor for OSA
Isabel Moreno Hay
Start Date
1/7/2026
Completion Date
3/1/2027
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.
Eligibility Criteria
Age Range: 18 years to 80 years
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).
Interventions
DEVICE
Under-mattress monitor
DEVICE
level 3 Home Sleep Apnea Test
DEVICE
Mandibular Advancement Device (MAD)
Conditions
Obstructive Sleep Apnea (OSAS)Obstructive Sleep Apnea (SAOS)
Locations
University of Kentucky
Lexington, Kentucky 40506
United States