Trial results for an internet-based cognitive-behavioral treatment for insomnia in patients with Chronic Obstructive Pulmonary Disease (COPD) were posted on ClinicalTrials.gov on 2026-04-17. The study found that participants receiving the internet-based treatment had a mean reduction of -3.07 in their Insomnia Severity Index (ISI) score compared to those receiving online insomnia patient education, though this difference was not statistically significant (p-value 0.121).
Background
Chronic Obstructive Pulmonary Disease (COPD) is a progressive lung disease that causes obstructed airflow from the lungs, leading to symptoms such as shortness of breath, cough, and wheezing. Patients with COPD often experience comorbidities, with insomnia being a common and impactful one. Insomnia can significantly worsen the quality of life for COPD patients, affecting their physical activity, mood, and overall health. Addressing insomnia in this population is therefore an important aspect of comprehensive care, potentially improving patient well-being and symptom management.
Trial design
This completed randomized controlled trial (NCT04700098) enrolled 13 participants to compare sleep and health-related functioning in Veterans with Chronic Obstructive Pulmonary Disease and Insomnia. The study design involved two arms: an Internet-based behavioral treatment for insomnia and online insomnia patient education. Participants underwent sleep and health assessments at baseline, post-treatment, and 3-months later. The trial did not list specific primary outcomes in its registration.
Key results
The study measured changes in the Insomnia Severity Index (ISI) and the St. George's Respiratory Questionnaire (SGRQ).
- For the Insomnia Severity Index (ISI), the Internet-based Behavioral Treatment for Insomnia group showed a mean change of -2.67 (Standard Deviation 4.62) on a score scale. The Online Insomnia Patient Education group showed a mean change of 0.40 (Standard Deviation 0.55). The Wilcoxon (Mann-Whitney) analysis indicated a Mean Difference (Final Values) of -3.07, with a p-value of 0.121.
- For the St. George's Respiratory Questionnaire (SGRQ), the Internet-based Behavioral Treatment for Insomnia group showed a mean change of 17.15 (Standard Deviation 3.42) on a score scale. The Online Insomnia Patient Education group showed a mean change of 1.57 (Standard Deviation 15.56). The Wilcoxon (Mann-Whitney) analysis indicated a Mean Difference (Final Values) of 15.58, with a p-value of 0.3545.
What this means
While the internet-based behavioral treatment for insomnia showed a numerical improvement in Insomnia Severity Index scores compared to online patient education, this difference did not reach statistical significance. Similarly, no statistically significant difference was observed for the St. George's Respiratory Questionnaire. The small enrollment of 13 participants may have limited the power of the study to detect statistically significant differences. These findings suggest a potential trend towards benefit for internet-based CBT in managing insomnia in COPD patients, but larger studies are needed to confirm these preliminary observations and determine their clinical significance.
Source
The information regarding these trial results was obtained from ClinicalTrials.gov, a public database of clinical studies. The results for study NCT04700098, titled "Internet-based Cognitive-behavioral Treatment for Insomnia in COPD Patients Undergoing Pulmonary Rehabilitation," were posted on 2026-04-17 on clinicaltrials.gov.