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

NCT07838870 | Not Yet Recruiting FDA Device

• 1 other identifier: STUDY25070167
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Obstructive Sleep Apnea; Comorbid Insomnia and Sleep Apnea; Insomnia

Keywords

obstructive sleep apnea; apnea; insomnia; comorbid insomnia and sleep apnea; upper airway stimulation; hypoglossal nerve stimulation; Noctem; University of Pittsburgh; compliance; cognitive behavioral therapy for insomnia; CBT-i; COAST

Outcome Measures

Primary Outcomes (2)

• UAS adherence

  UAS adherence will be measured by average hours of use per night

  1 month, 3 months, and 6 months post-UAS activation

• Change in Insomnia Severity Index (ISI)

  The Insomnia Severity Index (ISI) is a patient's subjective assessment of their ability to fall and stay asleep. The ISI is a 7 item measure. Answers per item range from 0-4 (0 meaning none/very satisfied-4 meaning very severe/very dissatisfied). Scoring totals range from 0-28. Lower score is better. Higher score suggests worse insomnia.

  Change from Baseline at Activation, 1 month, 3 months and 6 months

Secondary Outcomes (3)

• UAS adherence-overall usage

  1 month, 3 months, and 6 months post-UAS activation

• UAS adherence- % nights with >= 4 hours of usage

  1 month post activation, 3 months post activation, and 6 months post activation.

• UAS average number of pauses per night

  1 month post activation, 3 months post activation, and 6 months post activation.

Study Arms (2)

Upfront Digital CBT-i Arm

ACTIVE COMPARATOR

Digital CBT-i will be delivered prior to Upper Airway Stimulation activation in patients with comorbid insomnia and obstructive sleep apnea

Device: Digital Cognitive Behavioral Therapy (CBT-i)-COAST

Delayed Digital CBT-i Arm

ACTIVE COMPARATOR

Digital CBT-i will be delivered approximately 3 months after Upper Airway Stimulation activation in patients with comorbid insomnia and obstructive sleep apnea

Device: Digital Cognitive Behavioral Therapy (CBT-i)-COAST

Interventions

Digital Cognitive Behavioral Therapy (CBT-i)-COAST DEVICE

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.

Delayed Digital CBT-i Arm; Upfront Digital CBT-i Arm

Eligibility Criteria

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

You may qualify if:

• being seen and treated at the designated study locations for OSA with:
• a diagnosis of insomnia (defined as ISI ≥10, or prescribed hypnotic medication (trazadone, zolpidem, eszopiclone, doxepin), or a diagnosis of insomnia \[International Classification of Sleep Disorders 3 criteria\]).
• internet-capable device (e.g., smartphone, tablet, or computer)
• able to download and use the COAST app for administration of the intervention
• able to download and Inspire smartphone app utilized for clinical compliance information collection
• Included patients must meet FDA indications for UAS (qualifying apnea-hypopnea index score (AHI), body mass index (AHI) and appropriate anatomical airway collapse pattern as evaluated through clinically required drug induced sleep endoscopy DISE) and be scheduled for UAS implantation in typical clinical care settings at UPMC.

You may not qualify if:

• engaged in CBT-I in past 6 months
• does not have access to or unable to use internet capable device (smartphone, tablet or computer)

Sponsors & Collaborators

• Thomas Kaffenberger: lead
• Inspire Medical Systems, Inc.: collaborator
• Noctem, LLC: collaborator

Study Sites (1)

UPMC Mercy Hospital

Pittsburgh, Pennsylvania, 15219, United States

Location

Related Publications (6)

• Lettieri CJ, Shah AA, Holley AB, Kelly WF, Chang AS, Roop SA; CPAP Promotion and Prognosis-The Army Sleep Apnea Program Trial. Effects of a short course of eszopiclone on continuous positive airway pressure adherence: a randomized trial. Ann Intern Med. 2009 Nov 17;151(10):696-702. doi: 10.7326/0003-4819-151-10-200911170-00006.

  PMID: 19920270 BACKGROUND

• Sweetman A, Lack L, Catcheside PG, Antic NA, Smith S, Chai-Coetzer CL, Douglas J, O'grady A, Dunn N, Robinson J, Paul D, Williamson P, McEvoy RD. Cognitive and behavioral therapy for insomnia increases the use of continuous positive airway pressure therapy in obstructive sleep apnea participants with comorbid insomnia: a randomized clinical trial. Sleep. 2019 Dec 24;42(12):zsz178. doi: 10.1093/sleep/zsz178.

  PMID: 31403168 BACKGROUND

• Kaffenberger TM, Chandna M, Kaki P, Corr AM, Plawecki A, Doghramji K, Boon M, Huntley C. Reduced usage of upper airway stimulation therapy in patients with comorbid insomnia and obstructive sleep apnea. J Clin Sleep Med. 2023 Dec 1;19(12):1997-2004. doi: 10.5664/jcsm.10752.

  PMID: 37589148 BACKGROUND

• Dhanda Patil R, Hong MP, Ishman SL. Hypoglossal Nerve Stimulation in Veterans With Comorbid Insomnia and Sleep Apnea. Otolaryngol Head Neck Surg. 2021 Jun;164(6):1345-1353. doi: 10.1177/0194599820982638. Epub 2021 Jan 5.

  PMID: 33399502 BACKGROUND

• Soose RJ, Faber K, Greenberg H, Boon M, Woodson T, Strollo P. Post-implant care pathway: lessons learned and recommendations after 5 years of clinical implementation of hypoglossal nerve stimulation therapy. Sleep. 2021 Apr 27;44(Supplement_1):S4-S10. doi: 10.1093/sleep/zsaa279.

  PMID: 33313900 BACKGROUND

• Trauer JM, Qian MY, Doyle JS, Rajaratnam SM, Cunnington D. Cognitive Behavioral Therapy for Chronic Insomnia: A Systematic Review and Meta-analysis. Ann Intern Med. 2015 Aug 4;163(3):191-204. doi: 10.7326/M14-2841.

  PMID: 26054060 BACKGROUND

MeSH Terms

Conditions

Sleep Apnea, Obstructive; Sleep Apnea Syndromes; Sleep Initiation and Maintenance Disorders; Apnea; Patient Compliance

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior

Study Officials

• Thomas Kaffenberger

  University of Pittsburgh

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Tina Harrison

CONTACT

412-232-3282; Harrisonta@upmc.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant Professor, University of Pittsburgh, Department of Otolaryngology, Division of Sleep Medicine

Study Record Dates

• First Submitted: September 18, 2026
• First Posted: September 24, 2026
• Study Start (Estimated): November 5, 2026
• Primary Completion (Estimated): April 30, 2028
• Study Completion (Estimated): November 30, 2028
• Last Updated: September 24, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will share

Locations

US (1)