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COMPLETED NA

Insomnia Self-Management in Heart Failure

NCT02660385 · View on ClinicalTrials.gov ↗

Study Summary

Chronic insomnia may contribute to the development and exacerbation of heart failure (HF), incident mortality and contributes to common and disabling symptoms (fatigue, dyspnea, anxiety, depression, excessive daytime sleepiness, and pain) and decrements in objective and subjective functional performance. The purposes of the study are to evaluate the sustained effects of CBT-I on insomnia severity, sleep characteristics, daytime symptoms, and functional performance over twelve months among patients who have stable chronic HF and chronic insomnia. The effects of the treatment on outcomes of HF (hospitalization, death) and costs of the treatment will also be examined. A total of 200 participants will be randomized to 4 bi-weekly group sessions of cognitive behavioral therapy for CBT-I (behavioral was to improve insomnia and sleep) or HF self-management education. Participants will complete wrist actigraph (wrist-watch like accelerometer) measures of sleep, diaries, reaction time, and 6 minute walk test distance. They will also complete self-report measures of insomnia, sleep, symptoms, and functional performance. In addition the effects on symptoms and function over a period of one year.

Interventions

  • BEHAVIORAL Cognitive Behavioral Therapy for Insomnia
  • BEHAVIORAL Self-Management Education for Heart Failure

Study Locations (1)

Connecticut

  • Yale University School of Nursing — West Haven

Trial Details

FieldValue
Enrollment Target 195 participants
Start Date 2016-03-07
Est. Completion 2021-11-30
Phase NA

Sponsor

Yale University

1,283 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT02660385

The ClinicalTrials.gov registry entry for NCT02660385 describes a study currently listed as completed. It is categorized as NA, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 195 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Yale University, which has 1,283 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 10 conditions, with Heart Failure appearing as the primary indexed condition, and to 2 interventions — of which Cognitive Behavioral Therapy for Insomnia is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT02660385 reports 1 study location spanning 1 distinct geographic area — top geographies include Connecticut. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT02660385 about?

NCT02660385 is a clinical study titled "Insomnia Self-Management in Heart Failure". Chronic insomnia may contribute to the development and exacerbation of heart failure (HF), incident mortality and contributes to common and disabling symptoms (fatigue, dyspnea, anxiety, depression, excessive daytime sleepiness, and pain) and decrements in objective and subjective functional perform...

What is the current status of trial NCT02660385?

This trial is currently completed. It is a NA study. The enrollment target is 195 participants. The study started on 2016-03-07. Estimated completion is 2021-11-30.

What conditions does trial NCT02660385 study?

This clinical trial studies the following conditions: Heart Failure, Pain, Fatigue, Depressive Symptoms, Congestive Heart Failure. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT02660385?

The interventions under investigation include: Cognitive Behavioral Therapy for Insomnia (BEHAVIORAL), Self-Management Education for Heart Failure (BEHAVIORAL). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT02660385?

This trial is sponsored by Yale University, which has 1,283 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT02660385 being conducted?

This trial has 1 study location across Connecticut. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial