Trial Outcomes & Findings for Internet-based Cognitive-behavioral Treatment for Insomnia in COPD Patients Undergoing Pulmonary Rehabilitation (NCT NCT04700098)
NCT ID: NCT04700098
Last Updated: 2026-04-17
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
13 participants
Primary outcome timeframe
Baseline to 3-months post-treatment
Results posted on
2026-04-17
Participant Flow
Participant milestones
| Measure |
Internet-based Behavioral Treatment for Insomnia
Internet version of cognitive-behavioral treatment for insomnia
|
Online Insomnia Patient Education
Online insomnia patient education
|
|---|---|---|
|
Overall Study
STARTED
|
8
|
5
|
|
Overall Study
COMPLETED
|
3
|
5
|
|
Overall Study
NOT COMPLETED
|
5
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Internet-based Cognitive-behavioral Treatment for Insomnia in COPD Patients Undergoing Pulmonary Rehabilitation
Baseline characteristics by cohort
| Measure |
Internet-based Behavioral Treatment for Insomnia
n=8 Participants
Internet version of cognitive-behavioral treatment for insomnia
|
Online Insomnia Patient Education
n=5 Participants
Online insomnia patient education
|
Total
n=13 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
71.0 years
STANDARD_DEVIATION 7.2 • n=130 Participants
|
70.2 years
STANDARD_DEVIATION 7.4 • n=132 Participants
|
70.6 years
STANDARD_DEVIATION 6.7 • n=130 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=130 Participants
|
0 Participants
n=132 Participants
|
0 Participants
n=130 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=130 Participants
|
5 Participants
n=132 Participants
|
13 Participants
n=130 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=130 Participants
|
0 Participants
n=132 Participants
|
0 Participants
n=130 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=130 Participants
|
0 Participants
n=132 Participants
|
0 Participants
n=130 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=130 Participants
|
0 Participants
n=132 Participants
|
0 Participants
n=130 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=130 Participants
|
1 Participants
n=132 Participants
|
2 Participants
n=130 Participants
|
|
Race (NIH/OMB)
White
|
6 Participants
n=130 Participants
|
4 Participants
n=132 Participants
|
10 Participants
n=130 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=130 Participants
|
0 Participants
n=132 Participants
|
1 Participants
n=130 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=130 Participants
|
0 Participants
n=132 Participants
|
0 Participants
n=130 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=130 Participants
|
0 Participants
n=132 Participants
|
0 Participants
n=130 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
4 Participants
n=130 Participants
|
5 Participants
n=132 Participants
|
9 Participants
n=130 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
4 Participants
n=130 Participants
|
0 Participants
n=132 Participants
|
4 Participants
n=130 Participants
|
|
Insomnia Severity Index
|
14.4 score on a scale
STANDARD_DEVIATION 4.6 • n=130 Participants
|
17.0 score on a scale
STANDARD_DEVIATION 4.1 • n=132 Participants
|
15.5 score on a scale
STANDARD_DEVIATION 4.2 • n=130 Participants
|
|
St. George's Respiratory Questionnaire
|
52.2 score on a scale
STANDARD_DEVIATION 17.5 • n=130 Participants
|
45.4 score on a scale
STANDARD_DEVIATION 19.4 • n=132 Participants
|
49.6 score on a scale
STANDARD_DEVIATION 16.5 • n=130 Participants
|
PRIMARY outcome
Timeframe: Baseline to 3-months post-treatmentThe 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.
Outcome measures
| Measure |
Internet-based Behavioral Treatment for Insomnia
n=8 Participants
Internet version of cognitive-behavioral treatment for insomnia
|
Online Insomnia Patient Education
n=5 Participants
Online insomnia patient education
|
|---|---|---|
|
Insomnia Severity Index (ISI)
|
-2.67 score on a scale
Standard Deviation 4.62
|
0.40 score on a scale
Standard Deviation 0.55
|
PRIMARY outcome
Timeframe: Baseline to 3-months post-treatmentThe 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.
Outcome measures
| Measure |
Internet-based Behavioral Treatment for Insomnia
n=8 Participants
Internet version of cognitive-behavioral treatment for insomnia
|
Online Insomnia Patient Education
n=5 Participants
Online insomnia patient education
|
|---|---|---|
|
St. George's Respiratory Questionnaire (SGRQ)
|
17.15 score on a scale
Standard Deviation 3.42
|
1.57 score on a scale
Standard Deviation 15.56
|
Adverse Events
Internet-based Behavioral Treatment for Insomnia
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Online Insomnia Patient Education
Serious events: 1 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Internet-based Behavioral Treatment for Insomnia
n=8 participants at risk
Internet version of cognitive-behavioral treatment for insomnia
|
Online Insomnia Patient Education
n=5 participants at risk
Online insomnia patient education
|
|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
severe asthma attack requiring hospitalization
|
0.00%
0/8 • From baseline to end of follow-up at 3 months
|
20.0%
1/5 • From baseline to end of follow-up at 3 months
|
Other adverse events
| Measure |
Internet-based Behavioral Treatment for Insomnia
n=8 participants at risk
Internet version of cognitive-behavioral treatment for insomnia
|
Online Insomnia Patient Education
n=5 participants at risk
Online insomnia patient education
|
|---|---|---|
|
General disorders
fall
|
12.5%
1/8 • From baseline to end of follow-up at 3 months
|
0.00%
0/5 • From baseline to end of follow-up at 3 months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place