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NCT02232204 · ClinicalTrials.gov registry record · Phase 2
Sleep and Ventricular Arrhythmias Study
A Phase 2 study, sponsored by University of Florida.
- Completed
- Registry status
- Phase 2
- Development phase
- 3
- Enrollment target
NCT02232204 is a Phase 2 study that has completed, run by University of Florida. The registered enrollment target is 3 participants.
The verdict
NCT02232204, a Phase 2 study, has completed, sponsored by University of Florida.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 3 participants
- Enrollment target
Study Summary
This is a single-center, randomized controlled trial study design. Enrolled participants have a cardiovascular condition for which they are undergoing implantable cardioverter defibrillator (ICD) therapy and comorbid insomnia. Participants were randomized to a behavioral intervention for insomnia in ICD patients or a waitlist control. The treatment intervention period lasted 4 weeks with a telephone booster session administered at 3 month follow-up. The objective of the study is to examine the impact of a brief therapy combining established behavioral approaches to treating insomnia with novel components to target negative cognitions and anxieties associated with cardiac disease and ICD implantation. Primary patient outcomes include sleep, psychological functioning, daytime functioning, cardiac functioning, cognitive performance, and ICD adjustment.
Interventions
- BEHAVIORAL CBT for Insomnia in ICD Patients (CBT-I-ICD)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 3 participants |
| Start Date | 2009-10 |
| Est. Completion | 2012-01 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02232204
The ClinicalTrials.gov registry entry for NCT02232204 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 3 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Florida, which has 1,106 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which CBT for Insomnia in ICD Patients (CBT-I-ICD) is the first listed.
NCT02232204 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02232204 about?
NCT02232204 is a clinical study titled "Sleep and Ventricular Arrhythmias Study". This is a single-center, randomized controlled trial study design. Enrolled participants have a cardiovascular condition for which they are undergoing implantable cardioverter defibrillator (ICD) therapy and comorbid insomnia. Participants were randomized to a behavioral intervention for insomnia in...
What is the current status of trial NCT02232204?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 3 participants. The study started on 2009-10. Estimated completion is 2012-01.
What interventions are being tested in trial NCT02232204?
The interventions under investigation include: CBT for Insomnia in ICD Patients (CBT-I-ICD) (BEHAVIORAL).
Who is sponsoring clinical trial NCT02232204?
This trial is sponsored by University of Florida, which has 1,106 total clinical trials registered on ClinicalTrials.gov.
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