Heart Failure With Preserved Ejection Fraction
Conditions
Keywords
Sleep Efficiency, Sleep Extension, Heart Failure with Preserved Ejection Fraction, Quality of Life
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.
Interventions
BEHAVIORALCustomized Sleep Coaching
Demonstrate the feasibility of a gradual sleep extension strategy using customized sleep coaching.
BEHAVIORALSleep Hygiene Training
Sleep hygiene training aimed at increasing sleep efficiency in patients with heart failure with preserved ejection fraction on guideline-directed medical therapy
Sponsors
Sleep Research Society Foundation (SRSF)
Virginia Commonwealth University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Single-arm open-label feasibility study
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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. |
Countries
United States
Outcome results
None listed