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Internet-based Cognitive-behavioral Treatment for Insomnia in COPD Patients Undergoing Pulmonary Rehabilitation
NA trial testing Internet-based behavioral treatment for insomnia in Chronic Obstructive Pulmonary Disease in 13 participants. Completed in 30 June 2025.
| Lead sponsor | VA Office of Research and Development |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | single |
| Primary purpose | treatment |
| Enrollment | 13 |
| Start date | 14 February 2022 |
| Primary completion | 31 March 2025 |
| Estimated completion | 30 June 2025 |
| Sites | 2 locations across United States |
VA Office of Research and Development — full company profile →
40 and older, any sex, with Chronic Obstructive Pulmonary Disease or Insomnia. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
The ISI is a 7-item self-report questionnaire assessing nature, severity and impact of insomnia symptoms. The total score ranges from 0 to 28, with higher scores indicating worse insomnia severity.
| Group | Value | 95% CI |
|---|---|---|
| Internet-based Behavioral Treatment for Insomnia | -2.67 | ± 4.62 |
| Online Insomnia Patient Education | 0.40 | ± 0.55 |
The SGRQ is a 50-item measure assessing disease-specific quality of life. The total SGRQ score, which reflects the overall impact of the disease on quality of life, ranges from 0 to 100, with higher scores indicating greater impairment.
| Group | Value | 95% CI |
|---|---|---|
| Internet-based Behavioral Treatment for Insomnia | 17.15 | ± 3.42 |
| Online Insomnia Patient Education | 1.57 | ± 15.56 |
Time frame: From baseline to end of follow-up at 3 months. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
| Reaction | System | Internet-based Behavioral … | Online Insomnia Patient Ed… |
|---|---|---|---|
| severe asthma attack requiring hospitalization | Respiratory, thoracic and mediastinal disorders | — | — |
| Reaction | System | Internet-based Behavioral … | Online Insomnia Patient Ed… |
|---|---|---|---|
| fall | General disorders | — | — |
Most-reported serious reactions: severe asthma attack requiring hospitalization.
Data from ClinicalTrials.gov NCT04700098 adverse events section.
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.
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
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Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing