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

NCT06567925 | Completed

• 1 other identifier: HM20028346
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Heart Failure With Preserved Ejection Fraction

Keywords

Sleep Efficiency; Sleep Extension; Heart Failure with Preserved Ejection Fraction; Quality of Life

Outcome Measures

Primary Outcomes (4)

• Demonstrate the feasibility of a gradual sleep extension strategy combined with sleep hygiene training using a wearable device

  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

  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.

  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.

  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)

Study Arms (1)

Gradual sleep extension strategy

EXPERIMENTAL

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; Behavioral: Sleep Hygiene Training

Interventions

Customized Sleep Coaching BEHAVIORAL

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

Gradual sleep extension strategy

Sleep Hygiene Training BEHAVIORAL

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

Gradual sleep extension strategy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Virginia Commonwealth University: lead
• Sleep Research Society Foundation (SRSF): collaborator

Study Sites (1)

Virginia Commonwealth University

Richmond, Virginia, 23298, United States

Location

Study Officials

• Salvatore Carbone

  Virginia Commonwealth University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Single-arm open-label feasibility study

Study Record Dates

• First Submitted: August 1, 2024
• First Posted: August 23, 2024
• Study Start: January 21, 2025
• Primary Completion: May 4, 2025
• Study Completion: May 4, 2025
• Last Updated: September 4, 2025

Record last verified: 2025-08

Locations

US (1)