Improving sleep quality in heart failure patients with preserved ejection fraction
Sleep Extension to Improve Sleep Efficiency and Quality of Life in Heart Failure With Preserved Ejection Fraction: the SLEEP-HF Pilot Study
This study is trying a new approach to help people with heart failure and preserved ejection fraction sleep better by combining extra sleep time with tips for good sleep habits.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 17 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Virginia Commonwealth University Academic / other |
| Locations | 1 site (Richmond, Virginia) |
| Trial ID | NCT06567925 on ClinicalTrials.gov |
What this trial studies
This pilot study aims to explore the feasibility of a sleep extension intervention combined with sleep hygiene training to enhance sleep efficiency in patients with heart failure with preserved ejection fraction (HFpEF). Over a total duration of three weeks, including a one-week run-in phase, 17 subjects will participate in a single-arm open-label study. The primary goal is to increase sleep duration and efficiency, which are critical for improving the quality of life and functional capacity in these patients. The study addresses the significant issue of poor sleep quality, which affects a large proportion of individuals with HFpEF.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 and older with a confirmed diagnosis of stable heart failure (NYHA class II-III) and poor sleep efficiency.
Not a fit: Patients with severe debilitating diseases, significant sleep disorders, or those taking sleep medications irregularly may not benefit from this study.
Why it matters
Potential benefit: If successful, this intervention could significantly improve the quality of life for patients suffering from heart failure with preserved ejection fraction.
How similar studies have performed: While the approach of sleep modulation in heart failure patients is relatively novel, similar studies have shown promising results in improving sleep quality and related health outcomes.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * confirmed clinical diagnosis of stable HF (NYHA class II-III) * left ventricular ejection fraction\>50% documented in the prior 12 months * aged ≥18 years * habitual reported sleep duration ≤7 hours * sleep efficiency \<85% measured during the 1-week run-in phase Exclusion Criteria: * concomitant conditions that can limit physical activity * severe debilitating diseases (ischemic heart disease. angina, arterial fibrillation, moderate to severe valvular disease) * taking sleep medicine or melatonin irregularly * pregnancy * stage V kidney disease (with dialysis) * shift worker * insomnia * hospitalization within the last 2 months * patients with sleep and circadian disorders * fluid overload * Adults unable to consent * Individuals who are not yet adults (infants, children, teenagers) * Pregnant women * Prisoners
Where this trial is running
Richmond, Virginia
- Virginia Commonwealth University — Richmond, Virginia, United States (Recruiting)
Study contacts
- Principal investigator: Salvatore Carbone — Virginia Commonwealth University
- Study coordinator: Syed Imran Ahmed
- Email: ahmeds20@vcu.edu
- Phone: (804) 767-9796
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.