NCT06567925Completed
Sleep Extension to Improve Sleep Efficiency and QoL in HF With Preserved Ejection Fraction: the SLEEP-HF Pilot Study
Sleep Extension to Improve Sleep Efficiency and Quality of Life in Heart Failure With Preserved Ejection Fraction: the SLEEP-HF Pilot Study
Source: ClinicalTrials.gov · Last updated 4 Sept 2025
Brief summary (registry, in English)
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, sleep efficiency (SE) measures how well an individual utilizes their time in bed for restorative sleep and it highly depends on actual sleep duration. Reduced SE is associated with a greater risk for heart failure (HF), which affects \~6.7 million adults in the US alone. HF with preserved ejection fraction (HFpEF) accounts for about half of all HF diagnoses and is associated with poor prognosis (30-50% 5-year mortality from diagnosis) and severely reduced quality of life (QoL). Long-term goal for the investigators is to identify sleep modulation as a potential therapeutic target to improve QoL in HFpEF, with poor SE being present in \~60% of patients with HFpEF. The study is aimed to see if the sleep modulation is feasible and modulating sleep can improve the QoL and functional capacity along with the reduction of inflammation among subjects with HFpEF.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 10 (actual)
- First submitted
- 1 Aug 2024
- Start date
- 21 Jan 2025
- Primary completion date
- 4 May 2025
- Lead sponsor
- Virginia Commonwealth University
- Diseases
- Heart failure
- NCT number
- NCT06567925
What you commit to
- Study type: Interventional
- Participants enrolled: 10
- From 21 Jan 2025 to the primary completion date, 4 May 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- concomitant conditions that can limit physical activity
Other illness
- severe debilitating diseases (ischemic heart disease. angina, arterial fibrillation, moderate to severe valvular disease)
- stage V kidney disease (with dialysis)
- patients with sleep and circadian disorders
Other
- taking sleep medicine or melatonin irregularly
- pregnancy
- shift worker
- insomnia
- hospitalization within the last 2 months
- fluid overload
- Adults unable to consent
- Individuals who are not yet adults (infants, children, teenagers)
- Pregnant women
- Prisoners
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Virginia Commonwealth University Coordinator of this site? Confirm its status | Richmond | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.