Recruiting

Mandibular Advancement Device

Sponsor:

Isabel Moreno Hay

Code:

NCT07186725

Conditions

Obstructive Sleep Apnea (OSAS)

Obstructive Sleep Apnea (SAOS)

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Under-mattress monitor

level 3 Home Sleep Apnea Test

Mandibular Advancement Device (MAD)

Study Details

Brief 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.

Conditions

Obstructive Sleep Apnea (OSAS)

Obstructive Sleep Apnea (SAOS)

Study ID

NCT07186725

Start date

Jan 7, 2026

Status verified date

Feb, 2026

Completion date

Mar, 2027

Anticipated

Primary completion date

Mar, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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

Enrollment

70 participants

Anticipated

Intervention Model

Single group

Primary purpose

Diagnostic

Interventions and Outcome Measures

Arms

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.

Interventions

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

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.

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

Primary outcome measure

  • Change in apnea-hypopnea index (AHI). [ Time Frame: Baseline and post-intervention (approximately 12 weeks) ]
  • Change in minimum oxygen desaturation level [ Time Frame: Baseline and post-intervention (approximately 12 weeks) ]

Central Contacts and Locations

Central contacts

Sumia Alyousef, BDS

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

Locations

University of Kentucky

Recruiting

Lexington, Kentucky, United States, 40506

Contacts

Sumia Alyousef, BDS

8593235500Sumia.Alyousef@uky.edu

More Information

Sponsor

Isabel Moreno Hay

Last update posted

Feb 3, 2026

Last verified

Feb, 2026

Keywords

  • Mandibular Advancement
  • Sleep Apnea
  • Oral Appliance
  • Home-based
  • Obstructive Sleep Apnea
  • Home-based device

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Isabel Moreno Hay on 2026-02-03.