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NCT03636880 · ClinicalTrials.gov registry record · NA
Heart Failure Insomnia Treatment Study
A NA study, sponsored by Ohio State University.
- Completed
- Registry status
- NA
- Development phase
- 76
- Enrollment target
NCT03636880: Completed NA study, sponsored by Ohio State University.
NCT03636880 is a NA study that has completed, run by Ohio State University. The registered enrollment target is 76 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (95% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03636880, a NA study, has completed, sponsored by Ohio State University.
- COMPLETED
- Registry status
- NA
- Development phase
- 76 participants
- Enrollment target
Study Summary
The purpose of this study is to compare a short, behavioral treatment for insomnia with sleep monitoring to determine whether these approaches are effective in reducing insomnia and improving sleep quality among patients with heart failure (HF). This study will also examine the relationship between insomnia and cognitive functioning in HF and the effects of the behavioral treatment on cognitive functioning, self-care, distress, HF symptoms, and functional status. Participants will be randomly assigned to four-sessions of a behavioral treatment (Brief Behavioral Treatment for Insomnia; BBTI) or sleep monitoring.
Primary Outcome
Insomnia symptoms will be measured with the 7-item self-report Insomnia Severity Index (ISI). This measure assesses the severity of sleep-onset and sleep maintenance difficulties, sleep satisfaction, as well as associated daytime dysfunction and distress over the prior two weeks. Items are answered on a 5-point Likert-scale from 0 'not at all' to 4 'extremely'. Total scores range from 0 to 28, with higher scores reflective of greater insomnia severity. Scores of 8 or greater indicate the presenc
Interventions
- BEHAVIORAL Brief treatment for Insomnia
- BEHAVIORAL Sleep Monitoring
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 76 participants |
| Start Date | 2017-02-24 |
| Est. Completion | 2023-08-29 |
| Phase | NA |
What the finished NCT03636880 record still lists
NCT03636880 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 76 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (95% lower).
The record links to 0 conditions, and to 2 interventions - of which Brief treatment for Insomnia is the first listed.
NCT03636880 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03636880 about?
NCT03636880 is a clinical study titled "Heart Failure Insomnia Treatment Study". The purpose of this study is to compare a short, behavioral treatment for insomnia with sleep monitoring to determine whether these approaches are effective in reducing insomnia and improving sleep quality among patients with heart failure (HF). This study will also examine the relationship between ...
What is the current status of trial NCT03636880?
This trial is currently completed. It is a NA study. The enrollment target is 76 participants. The study started on 2017-02-24. Estimated completion is 2023-08-29.
What interventions are being tested in trial NCT03636880?
The interventions under investigation include: Brief treatment for Insomnia (BEHAVIORAL), Sleep Monitoring (BEHAVIORAL).
Who is sponsoring clinical trial NCT03636880?
This trial is sponsored by Ohio State University, which has 552 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03636880's enrollment target sits among peer trials
76 1062nd of 2000 higher than 932 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA 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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