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

Not Applicable

Recruiting

• Conditions: Heart Failure With Preserved Ejection Fraction
• Interventions: Behavioral: Customized Sleep Coaching; Behavioral: Sleep Hygiene Training

• Registration Number: NCT06567925
• Lead Sponsor: Virginia Commonwealth University

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.

Study Timeline

• Study First Submitted: 2024-08-01
• Study First Submitted QC: 2024-08-21
• Study First Posted: 2024-08-23
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-20
• Last Update Posted: 2024-12-24
• Study Start: 2025-01-15
• Primary Completion: 2025-02
• Study Completion: 2025-02

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 17

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

Read More

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

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Gradual sleep extension strategy	Sleep Hygiene Training	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
Gradual sleep extension strategy	Customized Sleep Coaching	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

Primary Outcome Measures

Name	Time	Method
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.	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.
Demonstrate the feasibility of a gradual sleep extension strategy combined with sleep hygiene training using a wearable device	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.
Demonstrate the feasibility of a gradual sleep extension strategy combined with sleep hygiene training using a sleep journal	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.
Demonstrate the feasibility of a gradual sleep extension strategy combined with sleep hygiene training using the Pittsburgh Sleep Quality questionnaire.	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

Trial Locations

Locations (1)

Virginia Commonwealth University; 🇺🇸 Richmond, Virginia, United States