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

August 27, 2025 updated by: Virginia Commonwealth University

Sleep Extension to Improve Sleep Efficiency and Quality of Life in Heart Failure With Preserved Ejection Fraction: the SLEEP-HF Pilot Study

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

10

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Virginia
      • Richmond, Virginia, United States, 23298
        • Virginia Commonwealth University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Gradual sleep extension strategy
Demonstrate the feasibility of a gradual sleep extension strategy combined with sleep hygiene training aimed at increasing sleep efficiency in patients with heart failure with preserved ejection fraction on guideline-directed medical therapy
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Demonstrate the feasibility of a gradual sleep extension strategy combined with sleep hygiene training using a wearable device
Time Frame: Between baseline and 2 weeks of the intervention
To assess the sleep modulation, We will assess sleep quality using the two wearable devices. A research-based accelerometer (GT9X Link, ActiGraph, FL) will be used on the wrist using a 24-hour per day for 7 days wear protocol except shower and swimming for the 1-week run-in phase. The same wear protocol will be implemented for the 2 weeks of intervention. Sleep duration and rest in bed will be automatically detected by the Actigraph and translated by Actilife software with an epoch of 30 seconds.
Between baseline and 2 weeks of the intervention
Demonstrate the feasibility of a gradual sleep extension strategy combined with sleep hygiene training using a sleep journal
Time Frame: Between baseline and 2 weeks of the intervention
A sleep diary will be used to reinforce the assessment conducted by accelerometer. A sleep diary is a record of your sleep behaviors, quality and schedule. It can help you to gauge your total sleep time, mark your breaks in sleep and when they occur and track changes in your quality of sleep.
Between baseline and 2 weeks of the intervention
Demonstrate the feasibility of a gradual sleep extension strategy combined with sleep hygiene training using the Pittsburgh Sleep Quality questionnaire.
Time Frame: Baseline (week 1) and at the end of the follow-up period (week 3)
Pittsburgh Sleep Quality questionnaire: Pittsburgh Sleep Symptom Questionnaire - Insomnia (PSSQ_I) has 13 self-rated questions. Only questions 1,2 or 5 are used to determine the presence, frequency AND duration of sleep symptom criteria. Questions 6-13 are used to identify significant daytime consequences of the sleep complaint. Adding up the average scores of the seven factors gives a global PSQI score from 0 to 21, with 0-4 indicating "good" sleep and 5-21 indicating "poor" sleep
Baseline (week 1) and at the end of the follow-up period (week 3)
Demonstrate the feasibility of a gradual sleep extension strategy combined with sleep hygiene training using the Epworth Sleepiness Scale at baseline and at the end of the follow-up for subjectively assess sleep quality.
Time Frame: Baseline (week 1) and at the end of the follow-up period (week 3)
Epworth Sleepiness Scale: The Epworth sleepiness scale results range from 0 to 24. Results from 0 to 10 show average (normal) daytime sleepiness. A result under 10 may not be cause for concern or it could identify you have trouble sleeping (insomnia). A result from 11 to 24 indicates excessive (abnormal) daytime sleepiness.
Baseline (week 1) and at the end of the follow-up period (week 3)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Virginia Commonwealth University

Collaborators

Sleep Research Society Foundation (SRSF)

Investigators

  • Principal Investigator: Salvatore Carbone, Virginia Commonwealth University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 21, 2025

Primary Completion (Actual)

May 4, 2025

Study Completion (Actual)

May 4, 2025

Study Registration Dates

First Submitted

August 1, 2024

First Submitted That Met QC Criteria

August 21, 2024

First Posted (Actual)

August 23, 2024

Study Record Updates

Last Update Posted (Estimated)

September 4, 2025

Last Update Submitted That Met QC Criteria

August 27, 2025

Last Verified

August 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HM20028346

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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