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Sleep Extension to Improve Sleep Efficiency and QoL in HF With Preserved Ejection Fraction: the SLEEP-HF Pilot Study

NCT06567925 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2025-09-04

No results posted yet for this study

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.

Conditions

Interventions

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

Sponsors & Collaborators

  • Sleep Research Society Foundation (SRSF)

    collaborator UNKNOWN

  • Virginia Commonwealth University

    lead OTHER

Principal Investigators

  • Salvatore Carbone · Virginia Commonwealth University

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-01-21
Primary Completion
2025-05-04
Completion
2025-05-04

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06567925 on ClinicalTrials.gov