Status:
COMPLETED
Sleep and Ventricular Arrhythmias Study
Lead Sponsor:
University of Florida
Collaborating Sponsors:
National Heart, Lung, and Blood Institute (NHLBI)
Conditions:
Cardiac Arrhythmia
Implantable Defibrillator User
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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) ther...
Detailed Description
Participants will be asked to review the informed consent form and consent to the study prior to beginning any study procedure. There are six phases of this study: (1) an in-person interview, (2) an ...
Eligibility Criteria
Inclusion
- Current ICD implantation (single or dual lead ICD, ICD and pacemaker)
- Diagnosis of insomnia
- No sleep medications for at least 1 month, or stable on medications for at least 6 months
- Willing to be randomly assigned to treatment
- Able to read and understand English
Exclusion
- Sleep disorder other than insomnia
- Significant medical condition other than cardiac disease
- Severe untreated psychopathology
- Neurological disorder
- Cognitive impairment
Key Trial Info
Start Date :
October 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2012
Estimated Enrollment :
3 Patients enrolled
Trial Details
Trial ID
NCT02232204
Start Date
October 1 2009
End Date
January 1 2012
Last Update
September 5 2014
Active Locations (1)
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1
University of Florida Aging
Gainesville, Florida, United States, 32610