N/A
Completed N=13
Internet-based Cognitive-behavioral Treatment for Insomnia in COPD Patients Undergoing Pulmonary Rehabilitation
Source: ClinicalTrials.gov NCT04700098 ↗Enrolled (actual)
13
Serious AEs
7.7%
Results posted
Apr 2026
Primary outcomePrimary: Insomnia Severity Index (ISI) — -2.67; 0.40 score on a scale — p=0.121
Summary
This study is a randomized controlled trial (RCT) to compare sleep and health-related functioning in Veterans with chronic obstructive pulmonary disease (COPD) and insomnia receiving an Internet-based behavioral treatment for insomnia versus online insomnia patient education. Participants will undergo a sleep and health assessment that will be performed at baseline, post-treatment, and 3-months later. Participants will be randomly assigned to either Internet-based behavioral treatment for insomnia or online insomnia patient education.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Insomnia Severity Index (ISI) |
-2.67; 0.40 | 0.121 |
| PRIMARY St. George's Respiratory Questionnaire (SGRQ) |
17.15; 1.57 | 0.3545 |
Eligibility Criteria
Inclusion Criteria
- Age 40 years and older
- Primary diagnosis of COPD defined by GOLD
- Meets criteria for Insomnia Disorder
- At least moderate insomnia severity based on Insomnia Severity Index score >7
- Stable psychiatric and medical conditions
- Must have telephone, email, and reliable Internet access via computer, smartphone, or tablet
Exclusion Criteria
- Untreated current major depression
- Serious suicidal risk
- Substance abuse disorder within past 3 months
- History of bipolar or psychosis
- Untreated restless legs syndrome, delayed sleep phase syndrome, irregular sleep schedules
- Very severe untreated obstructive sleep apnea
- Severe excessive daytime sleepiness based on Epworth Sleepiness Scale score > 16
- Restrictive lung disease (FEV1/FVC 70 and FEV1 < 80% predicted) or asthma
- Plans to move during the following 6 months
- Non-English speaking or sensory deficits
Data sourced from ClinicalTrials.gov (NCT04700098). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.