Home-Based Under-Mattress Monitoring Device to Estimate Mandibular Advancement in Oral Appliance Therapy for Obstructive Sleep Apnea

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 80
Healthy Volunteers: f
View:

• 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.

Locations
United States
Kentucky
University of Kentucky
RECRUITING
Lexington
Contact Information
Primary
Sumia Alyousef, BDS
Sumia.Alyousef@uky.edu
(859) 323-3440
Time Frame
Start Date: 2026-01-07
Estimated Completion Date: 2027-03
Participants
Target number of participants: 70
Treatments
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.
Related Therapeutic Areas
Sponsors
Collaborators: American Academy of Dental Sleep Medicine
Leads: Isabel Moreno Hay

This content was sourced from clinicaltrials.gov