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PulmonologyRandomized Clinical Trial3 min read

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

Blinded outcome assessments were conducted at baseline, posttreatment (6 weeks), and 3-month follow-up.

Published in American Journal of Respiratory and Critical Care MedicineRandomized controlled trial
5/5 Gold Standard
Evidence Meter · 5/5

Gold-Standard Human Evidence

Backed by randomized controlled human trials or a formal meta-analysis pooling multiple clinical studies.

Source

Study Duration

6 weeks

Clinician-guided D-CBT-I improved insomnia and OSA severity, and enhanced cognitive function in COMISA patients.

What Changes?

Pulmonology · Randomized Clinical Trial

Current Standard

Conventional pulmonology practice relies on standard-of-care monitoring and existing regimens prior to this .

New Finding

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.

3 Key Takeaways

Plain English Summary
  1. 01Core Finding

    Primary outcomes were Insomnia Severity Index (ISI) and Pittsburgh Sleep Quality Index (PSQI) scores at posttreatment and 3-month follow-up.

  2. 02Study Evidence

    Tested in a (n = 88) at the randomized clinical trial stage.

  3. 03Practical Meaning

    Controlled trial findings show causal benefit under protocol rules; real-world effectiveness can vary across patients.

What This Means for You

Clinician-guided D-CBT-I improved insomnia and OSA severity, and enhanced cognitive function in COMISA patients.

The Discovery

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.

How It Works, Simply

This pulmonology research focuses on airway remodeling & alveolar gas-exchange pathway. Researchers evaluated it using a randomized controlled trial (n = 88) at the randomized clinical trial stage of medical research.

3 Key Takeaways

Clinical Takeaways
  1. 01Core Finding

    Primary outcomes were Insomnia Severity Index (ISI) and Pittsburgh Sleep Quality Index (PSQI) scores at posttreatment and 3-month follow-up.

  2. 02Study Evidence

    Tested in a (n = 88) at the randomized clinical trial stage.

  3. 03Practical Meaning

    Controlled trial findings show causal benefit under protocol rules; real-world effectiveness can vary across patients.

Key Numbers

Quantitative Study Readout
3-month
Study Duration
n = 88
Study Cohort
01

Biological Mechanism & Study Design

Study Design & Cohort

Randomized controlled trial

Randomized controlled trial (n = 88) · Randomized Clinical Trial

Biological Pathway & Modality

Airway remodeling & alveolar gas-exchange pathway

Intervention: Clinician-guided digital CBT-I

02

Experimental Findings & Endpoints

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.

03

Clinical Translation & Practice Context

Clinician-guided D-CBT-I improved insomnia and OSA severity, and enhanced cognitive function in COMISA patients.

03

The Bottom Line · Clinical Pearl

“Clinician-guided D-CBT-I improved insomnia and OSA severity, and enhanced cognitive function in COMISA patients.”

Published in American Journal of Respiratory and Critical Care Medicine · Current Stage: Randomized Clinical Trial

Pulmonology · Randomized Clinical Trial
Study Type
Randomized controlled trial

Randomized controlled trial (n = 88)

Evidence Score
5/5 · Gold-Standard Human Evidence
Evidence Meter · 5/5

Gold-Standard Human Evidence

Backed by randomized controlled human trials or a formal meta-analysis pooling multiple clinical studies.

Backed by randomized controlled human trials or a formal meta-analysis pooling multiple clinical studies.

Who It Applies To
Patients with co-morbid insomnia and OSA: A Double-Blind
Intervention & Mechanism
Clinician-guided digital CBT-I

Airway remodeling & alveolar gas-exchange pathway

Key Limitation
Controlled trial findings show causal benefit under protocol rules; real-world effectiveness can vary across patients.

Translational Stage

LEVEL 1 · Randomized Clinical Trial

Classified as Randomized controlled trial along the clinical evidence continuum

  1. Lab & Discovery
  2. Early Trials
  3. 3Randomized Clinical TrialActive
  4. 4Meta & Practice

Original Publication & AMA Citation

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. American Journal of Respiratory and Critical Care Medicine. Published 2026;Oct 29. Accessed November 15, 2026. https://pubmed.ncbi.nlm.nih.gov/42958645/

American Journal of Respiratory and Critical Care Medicine

https://pubmed.ncbi.nlm.nih.gov/42958645/

Read Original Paper

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