Ignite Creation Date:
2024-10-26 @ 3:38 PM
Last Modification Date:
2024-10-26 @ 3:38 PM
Study NCT ID:
NCT06567925
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-08-01
Brief Title:
Sleep Extension to Improve Sleep Efficiency and QoL in HF With Preserved Ejection Fraction the SLEEP-HF Pilot Study
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Sleep Extension to Improve Sleep Efficiency and Quality of Life in Heart Failure With Preserved Ejection Fraction the SLEEP-HF Pilot Study
Status:
RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 67 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 investigators primary endpoint is to increase sleep duration and efficiency with this intervention
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None