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Behavioral Intervention

Sleep Extension for Heart Failure

N/A
Recruiting
Led By Salvatore Carbone
Research Sponsored by Virginia Commonwealth University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Confirmed clinical diagnosis of stable HF (NYHA class II-III)
Aged ≥18 years
Must not have
Adults unable to consent
Stage V kidney disease (with dialysis)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline (week 1) and at the end of the follow-up period (week 3)
Awards & highlights
No Placebo-Only Group

Summary

"This trial aims to investigate whether improving sleep quality in patients with heart failure with preserved ejection fraction (HFpEF) can lead to better quality of life and overall health outcomes. Poor sleep quality is

Who is the study for?
This trial is for adults with heart failure who have preserved ejection fraction—a condition where the heart chamber pumps out a normal amount of blood. Participants should have poor sleep quality but can't join if they have certain conditions that might interfere with the study or their ability to follow sleep coaching.
What is being tested?
The study tests whether improving sleep through Sleep Hygiene Training and Customized Sleep Coaching can enhance life quality, physical function, and reduce inflammation in patients with this type of heart failure.
What are the potential side effects?
Since the interventions involve non-medical techniques like training and coaching for better sleep habits, there are no direct medical side effects. However, changes in sleep patterns could temporarily affect mood or alertness.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My heart failure condition is stable and moderately affects my daily activities.
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I am 18 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I am unable to give consent for myself.
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I have advanced kidney disease and am on dialysis.
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I do not have severe heart conditions like angina or heart rhythm problems.
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I have been hospitalized in the last 2 months.
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I am under the age of 18.
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I am experiencing fluid retention.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline (week 1) and at the end of the follow-up period (week 3)
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline (week 1) and at the end of the follow-up period (week 3) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Demonstrate the feasibility of a gradual sleep extension strategy combined with sleep hygiene training using a sleep journal
Demonstrate the feasibility of a gradual sleep extension strategy combined with sleep hygiene training using a wearable device
Demonstrate the feasibility of a gradual sleep extension strategy combined with sleep hygiene training using the Epworth Sleepiness Scale at baseline and at the end of the follow-up for subjectively assess sleep quality.
+1 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: Gradual sleep extension strategyExperimental Treatment2 Interventions
Demonstrate the feasibility of a gradual sleep extension strategy combined with sleep hygiene training aimed at increasing sleep efficiency in patients with heart failure with preserved ejection fraction on guideline-directed medical therapy
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Sleep Hygiene Training
2021
N/A
~40

Find a Location

Who is running the clinical trial?

Virginia Commonwealth UniversityLead Sponsor
714 Previous Clinical Trials
22,888,474 Total Patients Enrolled
25 Trials studying Heart Failure
4,785 Patients Enrolled for Heart Failure
Sleep Research Society Foundation (SRSF)UNKNOWN
Salvatore CarbonePrincipal InvestigatorVirginia Commonwealth University
~11 spots leftby Feb 2025
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