Obstructive Sleep ApneaCBT-i and UASNCT07838870
Does the Timing of Insomnia Therapy (CBT-i) Impact the Usage and Compliance of Upper Airway Stimulation (UAS) Treatment of Obstructive Sleep Apnea (OSA)
A study testing Digital Cognitive Behavioral Therapy (CBT-i)-COAST in people with Obstructive Sleep Apnea and Comorbid Insomnia and Sleep Apnea, run by Thomas Kaffenberger at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Obstructive Sleep Apnea, Comorbid Insomnia and Sleep Apnea, Insomnia
- What is being tested?
- Digital Cognitive Behavioral Therapy (CBT-i)-COAST
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Nov 2026to 30 Nov 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- -engaged in CBT-I in past 6 months
- does not have access to or unable to use internet capable device (smartphone, tablet or computer)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
UPMC Mercy Hospital
Pittsburgh, Pennsylvania, 15219
Tina Harrison, 412-232-3282, harrisonta@upmc.edu
About this study
Official title: Cognitive Behavioral Therapy for Insomnia to Improve Upper Airway Stimulation Adherence in Comorbid Insomnia and Obstructive Sleep Apnea
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.
- Being tested
- Digital Cognitive Behavioral Therapy (CBT-i)-COAST
- 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
- Medical subject headings
- Sleep Apnea, Obstructive, Sleep Apnea Syndromes, Sleep Initiation and Maintenance Disorders, Apnea, Patient Compliance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Digital Cognitive Behavioral Therapy (CBT-i)-COASTDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Device: Digital Cognitive Behavioral Therapy (CBT-i)-COAST |
What is being measured
The primary outcome is the main question the study is designed to answer.
UAS adherence
UAS adherence will be measured by average hours of use per night
Measured: 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.
Measured: Change from Baseline at Activation, 1 month, 3 months and 6 months
Secondary outcomes (3)
UAS adherence-overall usage
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)
Measured: 1 month, 3 months, and 6 months post-UAS activation
UAS adherence- % nights with >= 4 hours of usage
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.
Measured: 1 month post activation, 3 months post activation, and 6 months post activation.
UAS average number of pauses per night
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.
Measured: 1 month post activation, 3 months post activation, and 6 months post activation.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2026
- Study start5 Nov 2026 (estimated)
- Primary completion30 Apr 2028 (estimated)
- Study completion30 Nov 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Obstructive Sleep ApneaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Thomas Kaffenberger
- Sponsor type
- University, hospital or other
- Collaborators
- Inspire Medical Systems, Inc., Noctem, LLC
- Responsible party
- Sponsor-investigator, Thomas Kaffenberger, University of Pittsburgh
- Investigators
- Thomas Kaffenberger, Principal investigator, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07838870
- Sponsor's protocol ID
- STUDY25070167
- Acronym
- CBT-i and UAS
- Status last verified
- Sep 2026
- First submitted
- 18 Sep 2026
- Last updated
- 24 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: De-identified IPD may be shared with the study sponsor Inspire Medical as a condition of funding and verification of study milestones achieved. Additionally, enrollment details will be shared with Noctem as part of the study conduct.
Publications
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.
PubMed 19920270Sweetman 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.
PubMed 31403168Kaffenberger 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.
PubMed 37589148Dhanda 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.
PubMed 33399502Soose 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.
PubMed 33313900Trauer 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.
PubMed 26054060
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cognitive Behavioral Therapy for Insomnia to Improve Upper Airway Stimulation Adherence in Comorbid Insomnia and Obstructive Sleep Apnea
- ClinicalTrials.gov ID
- NCT07838870
- Acronym / sponsor ID
- CBT-i and UAS / STUDY25070167
- Keywords
- obstructive sleep apnea, apnea, insomnia, comorbid insomnia and sleep apnea, upper airway stimulation, hypoglossal nerve stimulation, Noctem, University of Pittsburgh
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Thomas KaffenbergerUniversity, hospital or other
- Collaborators
- Inspire Medical Systems, Inc., Noctem, LLC
- Study start
- 5 Nov 2026 (estimated)
- Primary completion
- 30 Apr 2028 (estimated)
- Study completion
- 30 Nov 2028 (estimated)
- First posted
- 24 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Upfront Digital CBT-i Arm | Active comparator | Device: Digital Cognitive Behavioral Therapy (CBT-i)-COASTDigital CBT-i will be delivered prior to Upper Airway Stimulation activation in patients with comorbid insomnia and obstructive sleep apnea |
| Delayed Digital CBT-i Arm | Active comparator | Device: Digital Cognitive Behavioral Therapy (CBT-i)-COASTDigital CBT-i will be delivered approximately 3 months after Upper Airway Stimulation activation in patients with comorbid insomnia and obstructive sleep apnea |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (2 listed)
- -engaged in CBT-I in past 6 months
- does not have access to or unable to use internet capable device (smartphone, tablet or computer)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Digital Cognitive Behavioral Therapy (CBT-i)-COASTThe 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. | Device | Delayed Digital CBT-i Arm, Upfront Digital CBT-i Arm |
Primary outcome
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
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.
3 secondary outcomes
UAS adherence-overall usage
Time frame: 1 month, 3 months, and 6 months post-UAS activation
UAS adherence- % nights with >= 4 hours of usage
Time frame: 1 month post activation, 3 months post activation, and 6 months post activation.
UAS average number of pauses per night
Time frame: 1 month post activation, 3 months post activation, and 6 months post activation.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Sep 2026.
- Background: PubMed 19920270Lettieri 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.
- Background: PubMed 31403168Sweetman 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.
- Background: PubMed 37589148Kaffenberger 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.
- Background: PubMed 33399502Dhanda 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.
- Background: PubMed 33313900Soose 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.
- Background: PubMed 26054060Trauer 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.
- Individual participant dataSharing planned: Yes. De-identified IPD may be shared with the study sponsor Inspire Medical as a condition of funding and verification of study milestones achieved. Additionally, enrollment details will be shared with Noctem as part of the study conduct.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Thomas Kaffenberger principal investigator
University of Pittsburgh
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Digital Cognitive Behavioral Therapy (CBT-i)-COAST in people with Obstructive Sleep Apnea and Comorbid Insomnia and Sleep Apnea, run by Thomas Kaffenberger at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 24 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Tina Harrison (412-232-3282, Harrisonta@upmc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
UAS adherence (time frame: 1 month, 3 months, and 6 months post-UAS activation). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07838870, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Sep 2026.