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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: Completed NA study of Heart Failure and Pain, sponsored by Yale University.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Insomnia severity will be measured with the Insomnia Severity Index, a brief self-report instrument measuring patients' perception of their insomnia. The instrument includes 7 items assessing the severity of sleep onset and sleep maintenance difficulties, satisfaction with current sleep pattern, interference with daily functioning, noticeability of impairment attributed to the sleep problem, and degree of distress or concern caused by the sleep problem. Each item is rated on a 0-4 scale (4 indic
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 |
What the finished NCT02660385 record still lists
NCT02660385 is an interventional study that assigns participants to a tested intervention. The registered 195 participants enrollment target is mid-sized for trials with a published cap, below the 2,049-participant average among 397 other Heart Failure trials with a reported enrollment target (90% lower).
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 a single indexed study location in 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.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT02660385's enrollment target sits among peer trials
195 171st of 397 higher than 226 of 397 other Heart Failure trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Heart Failure trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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