Heart Failure Clinical Trial

Heart Failure Insomnia Treatment 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.

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Full Description

Comorbid insomnia is prevalent among heart failure (HF) patients and associated with poorer mental and physical functioning, including possible exacerbation of cognitive deficits. Initial investigations document the effectiveness of cognitive-behavioral therapy for the treatment of insomnia in HF. However, the high symptom burden of HF necessitates alternative interventions for these patients with fewer time and physical endurance demands.

Brief Behavioral Treatment for Insomnia (BBTI) is a four-session behavioral intervention that emphasizes stimulus control and sleep restriction techniques, along with providing education to patients about healthy sleep practices and behaviors that adversely affect sleep. The efficacy of BBTI has been previously documented in samples of older adults with insomnia, but the intervention has yet to be applied to a disease-specific patient population.

This study was designed to 1) evaluate the treatment effects of BBTI on insomnia among HF patients, 2) examine the relationship between insomnia, cognitive function, and decision-making in HF patients at baseline, and 3) evaluate the effects of BBTI on relevant correlates of insomnia in HF patients, including cognitive functioning, decision-making, distress, self-care, quality of life, and functional status.

Participants will be randomized to either the four-session behavioral intervention (BBTI) or a sleep monitoring condition. Measures of sleep (insomnia, sleep efficiency, sleep quality), cognitive functioning (memory, attention, executive functioning, and decision making), distress (anxiety and depression), HF-related quality of life, HF self-care, and functional status will be obtained from participants at baseline, post-intervention, and 6 months post-intervention. Repeated measures multivariate analysis of variance (MANOVA) will serve as the primary mode of data analysis.

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Eligibility Criteria

Inclusion Criteria:

18 years of age or older
Fluent in English
Diagnosis of heart failure
At least mild chronic insomnia

Exclusion Criteria:

Restless legs syndrome
Narcolepsy
Perform night or rotating shift work
Seizure disorder
Excessive daytime sleepiness
Current or past diagnosis of Bipolar disorder or psychotic disorder
Significant cognitive impairments
Untreated moderate to severe sleep apnea or high risk for sleep apnea

Study is for people with:

Heart Failure

Estimated Enrollment:

76

Study ID:

NCT03636880

Recruitment Status:

Completed

Sponsor:

Ohio State University

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There is 1 Location for this study

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The Ohio State University Wexner Medical Center
Columbus Ohio, 43210, United States

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Study is for people with:

Heart Failure

Estimated Enrollment:

76

Study ID:

NCT03636880

Recruitment Status:

Completed

Sponsor:


Ohio State University

How clear is this clinincal trial information?

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