Sleep and Ventricular Arrhythmias Study

Completed · Phase 2

Conditions studied: Cardiac Arrhythmia, Implantable Defibrillator User, Insomnia

In brief

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.

Key facts

Study ID: NCT02232204
Run by: University of Florida
People needed: 3
Starts: 2009-10-01
Expected to finish: 2012-01-01
Last updated by the study team: 2014-09-05

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

Sleep disorder other than insomnia
Significant medical condition other than cardiac disease
Severe untreated psychopathology
Neurological disorder
Cognitive impairment

Where it is running

University of Florida Aging — Gainesville, Florida, United States

Full record on ClinicalTrials.gov

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