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NCT01973647 · ClinicalTrials.gov registry record · NA
A Behavioral Therapy for Insomnia Co-existing With COPD
A NA study, sponsored by University of Illinois at Chicago.
- Completed
- Registry status
- NA
- Development phase
- 109
- Enrollment target
NCT01973647 is a NA study that has completed, run by University of Illinois at Chicago. The registered enrollment target is 109 participants.
The verdict
NCT01973647, a NA study, has completed, sponsored by University of Illinois at Chicago.
- COMPLETED
- Registry status
- NA
- Development phase
- 109 participants
- Enrollment target
Study Summary
Difficulty falling asleep, staying asleep or poor quality sleep (insomnia) is common in people with chronic obstructive pulmonary disease. Insomnia is related to greater mortality, with four times the risk of mortality for sleep times \< 300 minutes. Insomnia is also related to greater morbidity, with 75% greater health care costs than people without insomnia. However, insomnia medications are used with caution in COPD due to potential adverse effects. Common features of COPD such as dyspnea, chronic inflammation, anxiety and depression also affect insomnia and can interfere with therapy outcomes. While cognitive behavioral therapy for insomnia (CBT-I), a therapy that provides guidance on changing unhelpful sleep-related beliefs and behavior, is effective for people with primary insomnia and people with other chronic illnesses, the efficacy and mechanisms of action of such a therapy are yet unclear in people with both insomnia and COPD. The objective in this application is to rigorously test efficacy of two components of insomnia therapy - CBT-I and COPD education (COPD-ED) - in people with coexisting insomnia and COPD, and to identify mechanisms responsible for therapy outcomes. The central hypothesis is that both CBT-I and COPD-ED will have positive, lasting effects on objectively and subjectively measured insomnia and fatigue. The rationale for the proposed study is that once the efficacy and mechanisms of CBT-I and COPD-ED are known, new and innovative approaches for insomnia coexisting with COPD can be developed, thereby leading to longer, higher quality and more productive lives for people with COPD, and reduced societal cost due to the effects of insomnia. The investigators plan to test our central hypothesis by completing a randomized controlled comparison of CBT-I, COPD-ED and non-COPD, non-sleep health education attention control (AC) using a highly efficient 4-group design. Arm 1 comprises 6 weekly sessions of CBT-I+AC; Arm 2=6 sessions of COPD-ED+AC; Arm
Interventions
- BEHAVIORAL Attention Control
- BEHAVIORAL Cognitive Behavioral Therapy for Insomnia
- BEHAVIORAL COPD Education
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 109 participants |
| Start Date | 2014-06 |
| Est. Completion | 2019-07 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01973647
The ClinicalTrials.gov registry entry for NCT01973647 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 109 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Illinois at Chicago, which has 430 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Attention Control is the first listed.
NCT01973647 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01973647 about?
NCT01973647 is a clinical study titled "A Behavioral Therapy for Insomnia Co-existing With COPD". Difficulty falling asleep, staying asleep or poor quality sleep (insomnia) is common in people with chronic obstructive pulmonary disease. Insomnia is related to greater mortality, with four times the risk of mortality for sleep times \< 300 minutes. Insomnia is also related to greater morbidity, wi...
What is the current status of trial NCT01973647?
This trial is currently completed. It is a NA study. The enrollment target is 109 participants. The study started on 2014-06. Estimated completion is 2019-07.
What interventions are being tested in trial NCT01973647?
The interventions under investigation include: Attention Control (BEHAVIORAL), Cognitive Behavioral Therapy for Insomnia (BEHAVIORAL), COPD Education (BEHAVIORAL).
Who is sponsoring clinical trial NCT01973647?
This trial is sponsored by University of Illinois at Chicago, which has 430 total clinical trials registered on ClinicalTrials.gov.
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