Sleep Extension to Improve Sleep Efficiency and QoL in HF With Preserved Ejection Fraction: the SLEEP-HF Pilot Study
Launched by VIRGINIA COMMONWEALTH UNIVERSITY · Aug 21, 2024
Trial Information
Current as of July 23, 2025
Recruiting
Keywords
ClinConnect Summary
The SLEEP-HF Pilot Study is a clinical trial that aims to explore whether improving sleep can help people with heart failure who have preserved ejection fraction (HFpEF). This condition affects many adults and is linked to poor quality of life and higher health risks. The study focuses on participants who struggle with sleep efficiency, meaning they don't get restful sleep even when they're in bed. Researchers want to see if changes to sleep patterns can enhance quality of life, physical function, and reduce inflammation in these patients.
To be eligible for this trial, participants must be at least 18 years old and have a confirmed diagnosis of stable heart failure with a specific heart pump function. They should typically get less than 7 hours of sleep per night and have a sleep efficiency of less than 85%. Individuals with certain health issues, severe sleep disorders, or who are currently hospitalized are not eligible. Those who join the study can expect to take part in activities aimed at improving their sleep, which may help their overall well-being. This research could be important for finding new ways to support patients with heart failure in the future.
Gender
ALL
Eligibility 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
About Virginia Commonwealth University
Virginia Commonwealth University (VCU) is a prominent academic institution and research leader located in Richmond, Virginia. Renowned for its commitment to advancing healthcare through innovative research and education, VCU plays a pivotal role in clinical trials aimed at improving patient outcomes and understanding complex health issues. The university boasts a collaborative environment, leveraging its diverse faculty expertise and state-of-the-art facilities to conduct rigorous clinical research across various medical disciplines. VCU's dedication to ethical research practices and community engagement ensures that its clinical trials are designed to address critical health challenges while prioritizing participant safety and well-being.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Richmond, Virginia, United States
Patients applied
Trial Officials
Salvatore Carbone
Principal Investigator
Virginia Commonwealth University
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported