NCT06567925

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 10 (actual)
• Sponsor: Virginia Commonwealth University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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, 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.

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 sleep hygiene training to improve SE in patients with symptomatic HFpEF. The investigator's primary endpoint is to increase sleep duration and efficiency with this intervention.

Conditions

• Heart Failure With Preserved Ejection Fraction

Interventions

Type	Name	Description
BEHAVIORAL	Customized Sleep Coaching	Demonstrate the feasibility of a gradual sleep extension strategy using customized sleep coaching.
BEHAVIORAL	Sleep Hygiene Training	Sleep hygiene training aimed at increasing sleep efficiency in patients with heart failure with preserved ejection fraction on guideline-directed medical therapy

Timeline

• Start date: 2025-01-21
• Primary completion: 2025-05-04
• Completion: 2025-05-04
• First posted: 2024-08-23
• Last updated: 2025-09-04

Locations

1 site across 1 country: United States