An interventional study of Digital Cognitive Behavioral Therapy (CBT-i)-COAST in Obstructive Sleep Apnea, Comorbid Insomnia and Sleep Apnea and Insomnia, sponsored by Thomas Kaffenberger. Not yet recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-24.
Sponsored by Thomas Kaffenberger · Not applicable, Interventional, and Other
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.
2,240 studies on the registry are indexed under Sleep Apnea, Obstructive; 475 are open to participants now.
This study's planned enrollment of 100 is above the median of 52 across 1,472 interventional studies indexed under Sleep Apnea, Obstructive.
Browse Sleep Apnea, Obstructive studies →This is the only study on the registry with Thomas Kaffenberger as lead sponsor.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
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
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.
UAS adherence
UAS adherence will be measured by average hours of use per night
Time frame: 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.
Time frame: Change from Baseline at Activation, 1 month, 3 months and 6 months
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)
Time frame: 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.
Time frame: 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.
Time frame: 1 month post activation, 3 months post activation, and 6 months post activation.
Plan to share: 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.
This study is not yet recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
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