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

NCT ID: NCT06567925

Last Updated: 2025-09-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-01-21
• Study Completion Date: 2025-05-04

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, 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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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

Group Type: EXPERIMENTAL

Customized Sleep Coaching

Intervention Type: BEHAVIORAL

Demonstrate the feasibility of a gradual sleep extension strategy using customized sleep coaching.

Sleep Hygiene Training

Intervention Type: BEHAVIORAL

Sleep hygiene training aimed at increasing sleep efficiency in patients with heart failure with preserved ejection fraction on guideline-directed medical therapy

Interventions

Customized Sleep Coaching

Demonstrate the feasibility of a gradual sleep extension strategy using customized sleep coaching.

Intervention Type: 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

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sleep Research Society Foundation (SRSF)

UNKNOWN

Sponsor Role: collaborator

Virginia Commonwealth University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Salvatore Carbone

Role: PRINCIPAL_INVESTIGATOR

Virginia Commonwealth University

Locations

Virginia Commonwealth University

Richmond, Virginia, United States

Countries

United States

Other Identifiers

HM20028346

Identifier Type: -

Identifier Source: org_study_id