Clinical trial NCT06567925: Sleep Extension to Improve Sleep Efficiency and QoL in HF With Preserved Ejection Fraction: the SLEEP-HF Pilot Study
Official title: Sleep Extension to Improve Sleep Efficiency and Quality of Life in Heart Failure With Preserved Ejection Fraction: the SLEEP-HF Pilot Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Heart Failure With Preserved Ejection Fraction
Keywords: Sleep Efficiency
Sleep Extension
Heart Failure with Preserved Ejection Fraction
Quality of Life
Lead sponsor: Virginia Commonwealth University
Sponsor class: OTHER
Collaborators: name: Sleep Research Society Foundation (SRSF)
First posted: 2024-08-23
Enrollment: 17
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Single-arm open-label feasibility study
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Demonstrate the feasibility of a gradual sleep extension strategy combined with sleep hygiene training using a wearable device
timeFrame: Between baseline and 2 weeks of the intervention
measure: Demonstrate the feasibility of a gradual sleep extension strategy combined with sleep hygiene training using a sleep journal
timeFrame: Between baseline and 2 weeks of the intervention
measure: Demonstrate the feasibility of a gradual sleep extension strategy combined with sleep hygiene training using the Pittsburgh Sleep Quality questionnaire.
timeFrame: Baseline (week 1) and at the end of the follow-up period (week 3)
measure: 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.
timeFrame: Baseline (week 1) and at the end of the follow-up period (week 3)
Secondary outcomes:
Other outcomes:
Locations:
city: Richmond
country: United States
facility: Virginia Commonwealth University
state: Virginia
Study officials:
affiliation: Virginia Commonwealth University
name: Salvatore Carbone
role: PRINCIPAL_INVESTIGATOR
References: