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NCT02660385 · ClinicalTrials.gov registry record · NA
Insomnia Self-Management in Heart Failure
A NA study of Heart Failure and Pain, sponsored by Yale University.
- Completed
- Registry status
- NA
- Development phase
- 195
- Enrollment target
- 1
- Study location
NCT02660385 is a NA study of Heart Failure and Pain that has completed, run by Yale University. The registered enrollment target is 195 participants, below the 2,049-participant average among 397 other Heart Failure trials with a reported enrollment target (90% lower). The trial reports 1 study location across 1 state.
The verdict
NCT02660385, a NA study of Heart Failure and Pain, has completed, sponsored by Yale University.
- COMPLETED
- Registry status
- NA
- Development phase
- 195 participants
- Enrollment target
- 1
- Study location
Study Summary
Chronic insomnia may contribute to the development and exacerbation of heart failure (HF), incident mortality and contributes to common and disabling symptoms (fatigue, dyspnea, anxiety, depression, excessive daytime sleepiness, and pain) and decrements in objective and subjective functional performance. The purposes of the study are to evaluate the sustained effects of CBT-I on insomnia severity, sleep characteristics, daytime symptoms, and functional performance over twelve months among patients who have stable chronic HF and chronic insomnia. The effects of the treatment on outcomes of HF (hospitalization, death) and costs of the treatment will also be examined. A total of 200 participants will be randomized to 4 bi-weekly group sessions of cognitive behavioral therapy for CBT-I (behavioral was to improve insomnia and sleep) or HF self-management education. Participants will complete wrist actigraph (wrist-watch like accelerometer) measures of sleep, diaries, reaction time, and 6 minute walk test distance. They will also complete self-report measures of insomnia, sleep, symptoms, and functional performance. In addition the effects on symptoms and function over a period of one year.
Conditions Studied
Interventions
- BEHAVIORAL Cognitive Behavioral Therapy for Insomnia
- BEHAVIORAL Self-Management Education for Heart Failure
Study Locations (1)
Connecticut
- Yale University School of Nursing - West Haven
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 195 participants |
| Start Date | 2016-03-07 |
| Est. Completion | 2021-11-30 |
| Phase | NA |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02660385
The ClinicalTrials.gov registry entry for NCT02660385 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 195 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 2,049-participant average among 397 other Heart Failure trials with a reported enrollment target (90% lower). The listed sponsor is Yale University, which has 1,492 total studies on file at ClinicalTrials.gov.
The record links to 10 conditions, with Heart Failure appearing as the primary indexed condition, and to 2 interventions - of which Cognitive Behavioral Therapy for Insomnia is the first listed.
NCT02660385 reports 1 study location spanning 1 distinct geographic area - top geographies include Connecticut.
Frequently Asked Questions
What is clinical trial NCT02660385 about?
NCT02660385 is a clinical study titled "Insomnia Self-Management in Heart Failure". Chronic insomnia may contribute to the development and exacerbation of heart failure (HF), incident mortality and contributes to common and disabling symptoms (fatigue, dyspnea, anxiety, depression, excessive daytime sleepiness, and pain) and decrements in objective and subjective functional perform...
What is the current status of trial NCT02660385?
This trial is currently completed. It is a NA study. The enrollment target is 195 participants. The study started on 2016-03-07. Estimated completion is 2021-11-30.
What conditions does trial NCT02660385 study?
This clinical trial studies the following conditions: Heart Failure, Pain, Fatigue, Depressive Symptoms, Congestive Heart Failure.
What interventions are being tested in trial NCT02660385?
The interventions under investigation include: Cognitive Behavioral Therapy for Insomnia (BEHAVIORAL), Self-Management Education for Heart Failure (BEHAVIORAL).
Who is sponsoring clinical trial NCT02660385?
This trial is sponsored by Yale University, which has 1,492 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02660385 being conducted?
This trial has 1 study location across Connecticut. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Read our methodology - how this data is sourced, computed, and verified.
Related
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