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Purpose

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

Eligibility

Eligible Ages
Between 18 Years and 80 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

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).

Study Design

Phase
N/A
Study Type
Interventional
Allocation
N/A
Intervention Model
Single Group Assignment
Primary Purpose
Diagnostic
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
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.
  • Device: Under-mattress monitor
    the under-mattress monitor will be used in conjunction with the Alice NightOne at the beginning and end of the study, in addition, the under-mattress monitor will be used daily during sleep with the intraoral device in situ
    Other names:
    • Sleeptracker-AI
  • Device: level 3 Home Sleep Apnea Test
    Home sleep apnea test with Alice NightOne will be used for one day during sleep at the beginning and end of the study in conjunction with the Sleeptracker AI and the intraoral device.
    Other names:
    • Alice NightOne
  • Device: Mandibular Advancement Device (MAD)
    CAD-CAM, US Food and Drug Administration (FDA)-approved MAD, duo-bloc, customized, titratable sleep appliance. Participants will return every 2 weeks to the Orofacial Pain (OFP) clinic to progressively titrate the MAD advancement as needed until the under-mattress monitor scores an AHI < 5
    Other names:
    • D-SADTM Panthera Dental

Recruiting Locations

UK Center for Clinical and Translational Science and nearby locations

University of Kentucky
Lexington 4297983, Kentucky 6254925 40506
Contact:
Sumia Alyousef, BDS
8593235500
Sumia.Alyousef@uky.edu

More Details

NCT ID
NCT07186725
Status
Recruiting
Sponsor
Isabel Moreno Hay

Study Contact

Sumia Alyousef, BDS
(859) 323-3440
Sumia.Alyousef@uky.edu

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.