Chronic Obstructive Pulmonary DiseaseNCT04700098
Internet-based Cognitive-behavioral Treatment for Insomnia in COPD Patients Undergoing Pulmonary Rehabilitation
A study testing Internet-based behavioral treatment for insomnia and Online insomnia patient education in people with Chronic Obstructive Pulmonary Disease and Insomnia, run by VA Office of Research and Development at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease, Insomnia
- What is being tested?
- Internet-based behavioral treatment for insomnia and Online insomnia patient education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13 participants
- Where
- 2 sitesUnited States
- Study dates
- 14 Feb 2022to 30 Jun 2025
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 10Show fewer
- 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
Trial locations and contacts
2 sites in 1 country.
United States2 sites
John D. Dingell VA Medical Center, Detroit, MI
Detroit, Michigan, 48201-1916
VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA
Pittsburgh, Pennsylvania, 15240
About this study
Official title: Enhancing Pulmonary Rehabilitation in Veterans With Chronic Obstructive Pulmonary Disease Through Internet-based Cognitive-behavioral Treatment for Insomnia
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.
Read the detailed description
Veterans with chronic obstructive pulmonary disease (COPD) are a vulnerable group for developing insomnia. Insomnia has been found to be associated with limitations in activities of daily living (ADL), lower physical activity levels, poor quality of life, greater COPD symptom severity, and reduced exercise performance. Cognitive-behavioral therapy for insomnia (CBT-I) is an efficacious and durable non-pharmacological treatment for insomnia that provides guidance on changing unhealthy sleep-related beliefs and behaviors across a variety of illnesses. CBT-I not only improves sleep-specific symptoms of insomnia but also improves quality of life and daytime function, reduces ADL limitations, and improves condition-specific symptoms.
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. Veterans 40 years and older, who received care from the VA Pittsburgh Healthcare System, and who have COPD and insomnia will be recruited for this study. 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. Both the insomnia treatment and patient education will be provided remotely.
- Conditions
- Chronic Obstructive Pulmonary Disease, Insomnia
- Being tested
- Internet-based behavioral treatment for insomnia, Online insomnia patient education
- Keywords
- Chronic Obstructive Pulmonary Disease, Insomnia
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Internet-based behavioral treatment for insomniaBehavioural
Internet version of cognitive-behavioral treatment for insomnia
Online insomnia patient educationBehavioural
Online insomnia patient education
| Study group | Role | What they receive |
|---|---|---|
| Internet-based behavioral treatment for insomnia | Experimental | Internet version of cognitive-behavioral treatment for insomnia Receives: Behavioral: Internet-based behavioral treatment for insomnia |
| Online insomnia patient education | Experimental | Online insomnia patient education Receives: Behavioral: Online insomnia patient education |
What is being measured
The primary outcome is the main question the study is designed to answer.
Insomnia Severity Index (ISI)
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.
Measured: Baseline to 3-months post-treatment
St. George's Respiratory Questionnaire (SGRQ)
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.
Measured: Baseline to 3-months post-treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2021
- Study start14 Feb 2022
- Primary completion31 Mar 2025
- Study completion30 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Chronic Obstructive Pulmonary DiseaseStudies of the same condition, open and under way.
- More trials run by VA Office of Research and DevelopmentThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Individuals will be assigned to either an internet-based behavioral treatment for insomnia or online insomnia patient education.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Faith S Luyster, PhD, Principal investigator, VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04700098
- Sponsor's protocol ID
- F3513-R
- Status last verified
- Apr 2026
- First submitted
- 4 Jan 2021
- Last updated
- 17 Apr 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Enhancing Pulmonary Rehabilitation in Veterans With Chronic Obstructive Pulmonary Disease Through Internet-based Cognitive-behavioral Treatment for Insomnia
- ClinicalTrials.gov ID
- NCT04700098
- Acronym / sponsor ID
- F3513-R
- Conditions
- Chronic Obstructive Pulmonary Disease, Insomnia
- Keywords
- Chronic Obstructive Pulmonary Disease, Insomnia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Study start
- 14 Feb 2022 (actual)
- Primary completion
- 31 Mar 2025 (actual)
- Study completion
- 30 Jun 2025 (actual)
- First posted
- 7 Jan 2021 (actual)
- Results
- Posted 17 Apr 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Veterans with chronic obstructive pulmonary disease (COPD) are a vulnerable group for developing insomnia. Insomnia has been found to be associated with limitations in activities of daily living (ADL), lower physical activity levels, poor quality of life, greater COPD symptom severity, and reduced exercise performance. Cognitive-behavioral therapy for insomnia (CBT-I) is an efficacious and durable non-pharmacological treatment for insomnia that provides guidance on changing unhealthy sleep-related beliefs and behaviors across a variety of illnesses. CBT-I not only improves sleep-specific symptoms of insomnia but also improves quality of life and daytime function, reduces ADL limitations, and improves condition-specific symptoms.
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. Veterans 40 years and older, who received care from the VA Pittsburgh Healthcare System, and who have COPD and insomnia will be recruited for this study. 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. Both the insomnia treatment and patient education will be provided remotely.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Individuals will be assigned to either an internet-based behavioral treatment for insomnia or online insomnia patient education.
| Arm | Type | Receives |
|---|---|---|
| Internet-based behavioral treatment for insomnia | Experimental | Behavioral: Internet-based behavioral treatment for insomniaInternet version of cognitive-behavioral treatment for insomnia |
| Online insomnia patient education | Experimental | Behavioral: Online insomnia patient educationOnline insomnia patient education |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Internet-based behavioral treatment for insomniaInternet version of cognitive-behavioral treatment for insomnia | Behavioural | Internet-based behavioral treatment for insomnia |
| Online insomnia patient educationOnline insomnia patient education | Behavioural | Online insomnia patient education |
Primary outcome
Insomnia Severity Index (ISI)
Time frame: Baseline to 3-months post-treatment
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.
St. George's Respiratory Questionnaire (SGRQ)
Time frame: Baseline to 3-months post-treatment
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Faith S Luyster, PhD principal investigator
VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Internet-based behavioral treatment for insomnia and Online insomnia patient education in people with Chronic Obstructive Pulmonary Disease and Insomnia, run by VA Office of Research and Development at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 17 Apr 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Insomnia Severity Index (ISI) (time frame: Baseline to 3-months post-treatment). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Apr 2026.