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Clinical trial

Pulmonology · 4 h ago

Clinician-Guided Digital CBT-I Improves Insomnia Outcomes in COMISA Trial

In a randomized trial of 88 patients with comorbid insomnia and obstructive sleep apnea, clinician-guided digital CBT-I was compared with sleep hygiene education. At three months, CBT-I produced greater improvements in insomnia severity, sleep quality and subjective sleepiness; apnea severity also improved at post-treatment.

This randomized trial enrolled 88 patients with comorbid insomnia and obstructive sleep apnea (COMISA) and compared six weekly clinician-guided online cognitive behavioral therapy for insomnia (CBT-I) sessions with sleep hygiene education alone. Assessments were conducted at baseline, after treatment and at three-month follow-up. Primary outcomes were Insomnia Severity Index (ISI) and Pittsburgh Sleep Quality Index (PSQI) scores; secondary outcomes included sleepiness, apnea severity, cognition and adverse events.

At three months, intention-to-treat analyses found larger reductions with digital CBT-I than with sleep hygiene education in ISI scores (−9.5 vs. −4.0 points; effect size d=−1.18; P=0.001) and PSQI scores (−4.9 vs. −1.8; d=−0.87; P=0.001). Subjective sleepiness also decreased more (Epworth Sleepiness Scale −3.4 vs. −1.0; P<0.001). At post-treatment, the apnea–hypopnea index fell by 6.0 events/hour with CBT-I and rose by 2.0 with control (P=0.019). Transient sleepiness increases occurred during weeks 2–4, with no reported functional impairment or sleepiness-related adverse events. The findings support further evaluation of clinician-guided digital CBT-I in COMISA; the 88-person trial does not establish that it should replace existing care.

In practice

For adults with comorbid insomnia and obstructive sleep apnea, this randomized trial suggests clinician-guided digital CBT-I can improve insomnia severity, sleep quality and subjective sleepiness compared with sleep hygiene education, with a short-term reduction in apnea–hypopnea index. These results are promising but come from 88 participants and do not establish that the intervention should replace or alter established insomnia or OSA care. Sleepiness rose transiently during weeks 2–4, although no related functional impairment or adverse events were reported.

AI-generated clinical interpretation · Not editor-reviewed

AI summary · Not yet editor-reviewed

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