COMPLETED

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2025-01-21
Study Completion:2025-05-04
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:COMPLETED

Study ID

NCT06567925

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.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * confirmed clinical diagnosis of stable HF (NYHA class II-III)
  2. * left ventricular ejection fraction\>50% documented in the prior 12 months
  3. * aged ≥18 years
  4. * habitual reported sleep duration ≤7 hours
  5. * sleep efficiency \<85% measured during the 1-week run-in phase
  1. * concomitant conditions that can limit physical activity
  2. * severe debilitating diseases (ischemic heart disease. angina, arterial fibrillation, moderate to severe valvular disease)
  3. * taking sleep medicine or melatonin irregularly
  4. * pregnancy
  5. * stage V kidney disease (with dialysis)
  6. * shift worker
  7. * insomnia
  8. * hospitalization within the last 2 months
  9. * patients with sleep and circadian disorders
  10. * fluid overload
  11. * Adults unable to consent
  12. * Individuals who are not yet adults (infants, children, teenagers)
  13. * Pregnant women
  14. * Prisoners

Contacts and Locations

Principal Investigator

Salvatore Carbone
PRINCIPAL_INVESTIGATOR
Virginia Commonwealth University

Study Locations (Sites)

Virginia Commonwealth University
Richmond, Virginia, 23298
United States

Collaborators and Investigators

Sponsor: Virginia Commonwealth University

  • Salvatore Carbone, PRINCIPAL_INVESTIGATOR, 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 Registration Dates

Study Start Date2025-01-21
Study Completion Date2025-05-04

Study Record Updates

Study Start Date2025-01-21
Study Completion Date2025-05-04

Terms related to this study

Keywords Provided by Researchers

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

Additional Relevant MeSH Terms

  • Heart Failure With Preserved Ejection Fraction