An interventional study of Online Cognitive Behavioral Therapy (OCBT) and Therapist-directed Cognitive Behavioral Therapy (TCBT) in Insomnia, Primary and Sleep Apnea, Obstructive, sponsored by National Jewish Health. Active, not recruiting at 2 sites in United States. Open to participants aged 21 Years and older. Per ClinicalTrials.gov, last updated 2025-02-21.
Sponsored by National Jewish Health · Not applicable, Interventional, and Treatment
This two-site randomized clinical trial will investigate and compare three treatments for insomnia in patients who have been diagnosed with and treated for sleep apnea: online cognitive behavioral therapy (OCBT), therapist-directed cognitive behavioral therapy (TCBT), and standard clinical care. 384 patients will be recruited and will attend up to 15 visits over 10 months. Visits will include baseline assessment, treatment visits, and post-treatment follow-up visits. Visits will involve completion of questionnaires, meeting with therapists, and a physical exam.
This dual-site randomized clinical trial will use a "SMART" design to test a stepped care model relative to standard positive airway pressure (PAP) therapy and determine if (1) augmentation of PAP therapy with online Cognitive Behavioral Therapy improves short-term outcomes of comorbid obstructive sleep apnea(OSA)/insomnia; and (2) providing a higher intensity 2nd-stage cognitive behavioral therapy (CBT) to patients who show sub-optimal short-term outcomes with OCBT+PAP improves short and longer-term outcomes. After completing baseline assessment, the 384 comorbid OSA\insomnia patients enrolled will be randomized to a 1st-stage therapy that includes usual care PAP + OCBT (n=288) or UC (usual care PAP + sleep hygiene education; n=96). Insomnia and OSA will be reassessed after 8 weeks. OCBT recipients who meet "remission" criteria will continue PAP but be offered no additional insomnia intervention and will complete study outcome measures again after an additional 8-weeks and at 3 and 6 month follow-ups. OCBT recipients classified as "unremitted" after 8 weeks of treatment will be re-randomized to a 2nd-stage treatment consisting of continued, expanded engagement in OCBT or a switch to therapist-directed CBT (TCBT). Those receiving the 2nd-stage intervention as well as the UC group will be reassessed after another 8 weeks and at 3- and 6-month follow-up time points.
1,423 studies on the registry are indexed under Apnea; 160 are open to participants now.
This study's planned enrollment of 384 is above the median of 51 across 966 interventional studies indexed under Apnea.
Browse Apnea studies →National Jewish Health is the lead sponsor of 108 studies on the registry; 14 are open to participants now.
Counted across the registry records on this site, refreshed daily.
To be included participants must > 21 years old and:
Exclusion Criteria:
Participants randomized to standard care will receive normal follow-up care with their health care provider. This will include routine assessment and adjustment of PAP therapy, and instruction in proper sleep hygiene.
In addition to standard care procedures, participants randomized to the intervention arm will receive up to two sequential treatments. First, participants will receive Online Cognitive Behavioral Therapy (OCBT). Those who meet criteria for remission after this first treatment will continue through follow-up without further treatment. Those who do not will be randomized again to either extended OCBT, or Therapist-directed Cognitive Behavioral Therapy (TCBT).
Behavioral: Online Cognitive Behavioral Therapy (OCBT) · Behavioral: Therapist-directed Cognitive Behavioral Therapy (TCBT)
Cognitive behavioral therapy delivered via commercial online software.
Also known as: OCBT
Cognitive Behavioral Therapy delivered via traditional, in-person interaction with a licensed mental health professional.
Also known as: TCBT
Insomnia Severity Index (ISI) score change
Change in participants' score on the ISI will be measured over baseline, post-treatment, and follow-up visits.
Time frame: Symptom remission will be measured at post-treatment visits one and two, approximately 18 and 28 weeks following enrollment.
Quebec Sleep Questionnaire (QSQ) score change
Change in participants' score on the QSQ will be measured over baseline, post-treatment, and follow-up visits.
Time frame: Participants will be asked to complete the QSQ at baseline, post-treatment, and follow-up visits, at approximately weeks 1, 18, and 28.
Change in subjective measurement of total sleep time
Participants will be asked to fill out a sleep diary throughout the study. Study personnel will use these diaries to calculate subjective assessment of total sleep time.
Time frame: Participants will be asked to complete two weeks of sleep diaries at baseline (week 1), post-treatment (weeks 8 and 18), and follow-up visits (months 9 and 12) to measure change in these assessments over time.
Change in subjective measurement of sleep efficiency
Participants will be asked to fill out a sleep diary throughout the study. Study personnel will use these diaries to calculate subjective assessment of sleep efficiency.
Time frame: Participants will be asked to complete two weeks of sleep diaries at baseline (week 1), post-treatment (weeks 8 and 18), and follow-up visits (months 9 and 12) to measure change in these assessments over time.
Positive Airway Pressure (PAP) Therapy Adherence
Participants' adherence to PAP therapy will be passively monitored during their participation in the study.
Time frame: Adherence data will be collected through study completion, an average of one year.
Plan to share: No
This study is active, not recruiting, as verified in Feb 2025. You cannot join it, but the record below documents what was studied.
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