Insomnia Clinical Trial
— SAVEOfficial title:
Sleep in Cardiac Patients With Implantable Cardioverter Defibrillators (ICD)
Verified date | September 2014 |
Source | University of Florida |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Institutional Review Board |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 3 |
Est. completion date | January 2012 |
Est. primary completion date | October 2011 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - 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 Criteria: - Sleep disorder other than insomnia - Significant medical condition other than cardiac disease - Severe untreated psychopathology - Neurological disorder - Cognitive impairment |
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | University of Florida Aging | Gainesville | Florida |
Lead Sponsor | Collaborator |
---|---|
University of Florida | National Heart, Lung, and Blood Institute (NHLBI) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in subjective and objective sleep | Sleep diary and actigraphy-derived sleep parameters (averaged over each 14-day data collection period at baseline, post-treatment, and at 3-month follow-up) including: time to fall asleep (sleep onset latency), wake time during the night (waketime after sleep onset), total sleep time, amount of time spent in bed sleeping (sleep efficiency), total nap time, and sleep quality rating. | Change from baseline to the two study follow-ups (immediately and 3-months following treatment) | No |
Secondary | Change in psychological functioning | Changes in reported symptoms of anxiety and depression as assessed by questionnaires from baseline to immediately and 3 months following treatment. | Change from baseline to the two follow-up periods (immediately and 3-months following treatment) | No |
Secondary | Change in daytime functioning | The change in reported insomnia impact, fatigue, and sleepiness as assessed by questionnaires from baseline to immediately and 3 months following treatment. | Change from baseline to the two follow-up periods (immediately and 3-months following treatment) | No |
Secondary | Change in quality of life | The change in reported health-related quality of life as assessed by questionnaires from baseline to immediately and 3 months following treatment. | Change from baseline to the two follow-up periods (immediately and 3-months following treatment) | No |
Secondary | Change in cardiac functioning | The change in device-recorded incidence of ventricular arrhythmia from baseline to immediately and 3 months following treatment. | Change from baseline to the two follow-up periods (immediately and 3-months following treatment) | No |
Secondary | Change in device adjustment | The change in reported shock anxiety and device-specific acceptance as assessed by questionnaires from baseline to immediately and 3 months following treatment. | Change from baseline to the two follow-up periods (immediately and 3-months following treatment | No |
Secondary | Change in cognitive functioning | The change in computer-recorded cognitive functioning in the domains of executive control, reasoning, working memory, attention, and reaction time as assessed from baseline to immediately following treatment. | Change from baseline to immediately after treatment | No |
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