Status:
COMPLETED
Sleep Extension to Improve Sleep Efficiency and QoL in HF With Preserved Ejection Fraction: the SLEEP-HF Pilot Study
Lead Sponsor:
Virginia Commonwealth University
Collaborating Sponsors:
Sleep Research Society Foundation (SRSF)
Conditions:
Heart Failure With Preserved Ejection Fraction
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
Nearly one-third of US adults have poor sleep quality. Sleep quality refers to sleep efficiency, sleep latency, sleep duration, wake after sleep onset, and movement during the night. Specifically, sle...
Detailed Description
The investigators plan a 2-week single-arm open-label feasibility study in 17 subjects with HFpEF with a 1-week run-in phase (3 weeks total duration) with a sleep extension intervention combined with ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 21 2025
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 4 2025
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT06567925
Start Date
January 21 2025
End Date
May 4 2025
Last Update
September 4 2025
Active Locations (1)
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1
Virginia Commonwealth University
Richmond, Virginia, United States, 23298