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NCT Number: NCT07838870

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

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.

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Key information

Conditions

Obstructive Sleep Apnea Apnea Behavior Comorbid Insomnia and Sleep Apnea Dyssomnias Health Behavior Insomnia Mental Disorders Nervous System Diseases Pathological Conditions, Signs and Symptoms Patient Acceptance of Health Care Patient Compliance Respiration Disorders Respiratory Tract Diseases Signs and Symptoms Signs and Symptoms, Respiratory Sleep Apnea Syndromes Sleep Apnea, Obstructive Sleep Disorders, Intrinsic Sleep Initiation and Maintenance Disorders Sleep Wake Disorders Treatment Adherence and Compliance

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

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

Treatment and study plan

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.

Primary outcomes

  1. UAS adherence

    Time frame: 1 month, 3 months, and 6 months post-UAS activation

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

  2. Change in Insomnia Severity Index (ISI)

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

    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.

Secondary outcomes

  1. UAS adherence-overall usage

    Time frame: 1 month, 3 months, and 6 months post-UAS activation

    UAS adherence measured by % days used. This will be calculated dividing the number of days the UAS was turned on by the number of days since last timepoint which will yield a percentage. The higher the percentage, the better the compliance. (1 month~30 days; 3 months~90 days; 6 months~180 days)

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

    Time frame: 1 month post activation, 3 months post activation, and 6 months post activation.

    4 hours of nightly usage is an historical OSA treatment benchmark for compliance. This outcome measure will be calculated by identifying the number of nights the UAS system was used for 4+ hours and dividing it by the overall number of nights used to achieve a percentage. This will be calculated for each timepoint in the study. Higher percentage suggests better compliance.

  3. UAS average number of pauses per night

    Time frame: 1 month post activation, 3 months post activation, and 6 months post activation.

    UAS systems have the ability to be paused during usage. Common reasons for "pausing" are for comfort (so they can more easily fall back to sleep), to use the restroom, to take a drink/or take medication. Increased pausing can be associated with discomfort (the UAS system being too strong) or associated with sleep disorders (such as incomplete control of OSA or low arousal threshold). Pause events will be tallied and divided by the total number of nights the UAS system was used. Lower number of average pauses leads to higher overall usage of the UAS system and is preferred. This information can also be used to direct clinicians to readjust UAS settings or reeducate patients.

Study contacts

Contact information is provided by the study sponsor or research team.

Tina Harrison

CONTACT

[email protected]

412-232-3282

Sponsors and collaborators

Lead sponsor

Thomas Kaffenberger

Other

Collaborators

  • Inspire Medical Systems, Inc.
  • Noctem, LLC

Registry information

Official study title

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

Acronym: CBT-i and UAS

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Sep 24, 2026
Registry last updated
Sep 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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