Home-based Under Mattress Monitor for OSA

Official title

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

Overview

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.

Interventions

• 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
• 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.
• 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 measures

• 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)]

Secondary outcome measures (6)

• Change in Epworth Sleepiness Scale [Time frame: Baseline and post-intervention (approximately 12 weeks)]
• Change in Quality of Life Scale [Time frame: Baseline and post-intervention (approximately 12 weeks)]
• Change in Fatigue Assessment Scale [Time frame: Baseline and post-intervention (approximately 12 weeks)]
• Change in Pittsburgh Sleep Quality Index (PSQI) [Time frame: Baseline and post-intervention (approximately 12 weeks)]
• Change in Snore Outcomes Survey (SOS) [Time frame: Baseline and post-intervention (approximately 12 weeks)]
• Short Assessment of Patient Satisfaction [Time frame: Post Intervention, approximately week 12]

Eligibility criteria

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).

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

N/A

Model

Single group

Masking

Open label

Primary purpose

Diagnostic

Study locations

United States · 1 center

• University of Kentucky — Lexington

Identifiers

NCT: NCT07186725 · 97445

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗