Clinician-guided digital CBT-I improves sleep quality and apnea severity in patients with co-morbid insomnia and OSA: A Double-Blind, Randomized Clinical Trial.

Authors

Yuan Shi, Xujun Feng, Zhaohua Chen, Siqi Guan, Yihui Zhang, Fei Lei, Xiaomin Zhang, Yuting Jiang, Yanyan Wang, Michael V Vitiello, Xiangdong Tang

Published in

American journal of respiratory and critical care medicine. Oct 29, 2026. Epub Oct 29, 2026.

Abstract

Cognitive behavioral therapy for insomnia (CBT-I) is the accepted first-line treatment for insomnia, but its scalability and safety in patients with co-morbid insomnia and obstructive sleep apnea (COMISA) remain unclear. Clinician-guided digital CBT-I (D-CBT-I) is a potential treatment option that may address these limitations in COMISA.
To evaluate the effectiveness of clinician-guided D-CBT-I versus sleep hygiene education (SHE) in patients with COMISA.
This randomized trial (n = 88) compared clinician-guided D-CBT-I (6 weekly online sessions: sleep restriction, sleep hygiene, stimulus control, cognitive restructuring, relapse prevention) with SHE alone. Blinded outcome assessments were conducted at baseline, posttreatment (6 weeks), and 3-month follow-up. Primary outcomes were Insomnia Severity Index (ISI) and Pittsburgh Sleep Quality Index (PSQI) scores at posttreatment and 3-month follow-up. Secondary outcomes included daytime sleepiness, sleep parameters, OSA severity, neurocognitive function, and adverse events.
At 3-month follow-up, intention-to-treat analysis showed significantly greater improvements with D-CBT-I versus SHE on ISI (-9.5 vs. -4.0 points; d = -1.18, P = 0.001) and PSQI (-4.9 vs. -1.8 points; d = -0.87, P = 0.001); D-CBT-I also reduced subjective sleepiness (Epworth Sleepiness Scale; -3.4 vs. -1.0 points; d = -0.68, P < 0.001). At posttreatment, D-CBT-I reduced the apnea-hypopnea index (attended in-laboratory polysomnography; -6.0 vs. +2.0 events/h; d = -0.64, P = 0.019). Although transient increases in ESS occurred at weeks 2-4, no functional impairment or sleepiness-related adverse events were reported. Additional benefits were observed in metacognition and executive function.
Clinician-guided D-CBT-I improved insomnia and OSA severity, and enhanced cognitive function in COMISA patients.
Chinese Clinical Trial Registry; NO.: ChiCTR2500099854; URL: https://www.chictr.org.cn/showproj.html?proj=267457.

PMID:
42958645
Bibliographic data and abstract were imported from PubMed on 30 Oct 2026.

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