Home-based Under Mattress Monitor for OSA

NCT07186725 | Recruiting FDA Device

• 1 other identifier: 97445
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

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)

Keywords

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

Outcome Measures

Primary Outcomes (2)

• Change in apnea-hypopnea index (AHI).

  Number of apneas and hypopneas per hour of sleep which is an indicator of severity of sleep apnea, (5\< normal, 5-15 Mild, 15-30 moderate, \<30 severe)

  Baseline and post-intervention (approximately 12 weeks)

• Change in minimum oxygen desaturation level

  The minimum O2 level percentage during treatment

  Baseline and post-intervention (approximately 12 weeks)

Secondary Outcomes (6)

• Change in Epworth Sleepiness Scale

  Baseline and post-intervention (approximately 12 weeks)

• Change in Quality of Life Scale

  Baseline and post-intervention (approximately 12 weeks)

• Change in Fatigue Assessment Scale

  Baseline and post-intervention (approximately 12 weeks)

• Change in Pittsburgh Sleep Quality Index (PSQI)

  Baseline and post-intervention (approximately 12 weeks)

• Change in Snore Outcomes Survey (SOS)

  Baseline and post-intervention (approximately 12 weeks)

Study Arms (1)

Panthera DSAD mandibular advancement device users

EXPERIMENTAL

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; Device: level 3 Home Sleep Apnea Test; Device: Mandibular Advancement Device (MAD)

Interventions

Under-mattress monitor DEVICE

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

Also known as: Sleeptracker-AI

Panthera DSAD mandibular advancement device users

level 3 Home Sleep Apnea Test DEVICE

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.

Also known as: Alice NightOne

Panthera DSAD mandibular advancement device users

Mandibular Advancement Device (MAD) DEVICE

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

Also known as: D-SADTM Panthera Dental

Panthera DSAD mandibular advancement device users

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Isabel Moreno Hay: lead
• American Academy of Dental Sleep Medicine: collaborator

Study Sites (1)

University of Kentucky

Lexington, Kentucky, 40506, United States

RECRUITING

MeSH Terms

Conditions

Sleep Apnea, Obstructive; Sleep Apnea Syndromes

Interventions

Occlusal Splints

Condition Hierarchy (Ancestors)

Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Orthotic Devices; Orthopedic Equipment; Surgical Equipment; Equipment and Supplies

Study Officials

• Isabel Moreno Hay, DDS, PhD

  University of Kentucky

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sumia Alyousef, BDS

CONTACT

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: September 15, 2025
• First Posted: September 22, 2025
• Study Start: January 7, 2026
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): March 1, 2027
• Last Updated: February 3, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)