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NOT YET RECRUITING
NCT07838870
NA

Does the Timing of Insomnia Therapy (CBT-i) Impact the Usage and Compliance of Upper Airway Stimulation (UAS) Treatment of Obstructive Sleep Apnea (OSA)

Sponsor: Thomas Kaffenberger

View on ClinicalTrials.gov

Summary

Obstructive sleep apnea, or OSA, affects over 1 billion adults worldwide. OSA is one of many sleep disorders. Individuals can suffer from more than one sleep disorder at a time. Insomnia (difficulty falling or staying asleep) is a separate sleep disorder that is very often seen in OSA patients. Depending on reports, insomnia can be present in 30%-60% of patients diagnosed with OSA. This research is being conducted to determine whether treating insomnia can help patients with OSA to have better outcomes when treating their OSA.

Official title: Cognitive Behavioral Therapy for Insomnia to Improve Upper Airway Stimulation Adherence in Comorbid Insomnia and Obstructive Sleep Apnea

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

100

Start Date

2026-11-05

Completion Date

2028-11-30

Last Updated

2026-09-24

Healthy Volunteers

No

Interventions

DEVICE

Digital Cognitive Behavioral Therapy (CBT-i)-COAST

The COAST application will generate treatment recommendations after approximately one week of participant data entry. COAST's treatment recommendations are based on the core components of CBT-I-stimulus control, sleep restriction, cognitive therapy, and relaxation-with additional strategies targeting nightmares and daytime fatigue as needed. Weekly assessments and daily sleep diaries help the COAST algorithms make recommendations. The study clinician must review and approve, or change, all recommendations before they are sent to the participant. This tailored approach allows for modification of COAST's recommendations based on clinician expertise and knowledge of the participant. To further enhance the treatment process, the clinician is available by secure message to provide rapid support and/or schedule an appointment as needed. These features offer personalization for each participant, consistent with case-conceptualization based on individual sleep needs.

Locations (1)

UPMC Mercy Hospital

Pittsburgh, Pennsylvania, United States