Sleep Extension for Heart Failure

Overseen By Salvatore Carbone

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Virginia Commonwealth University

Must not be taking: Sleep medicine, Melatonin

Disqualifiers: Severe diseases, Pregnancy, Insomnia, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 5

Duration: 2 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if improving sleep can benefit individuals with heart failure with preserved ejection fraction (HFpEF), a condition linked to poor sleep and quality of life. Participants will receive Customized Sleep Coaching and Sleep Hygiene Training, which focus on sleep coaching and training in good sleep habits to improve sleep quality. The goal is that better sleep will enhance quality of life and reduce inflammation. Candidates for this trial include those with stable heart failure who sleep less than seven hours a night and have difficulty staying asleep. As an unphased trial, this study provides a unique opportunity to explore innovative sleep interventions that could enhance quality of life.

Do I have to stop taking my current medications for the trial?

The trial protocol does not specify whether you need to stop taking your current medications. However, if you are taking sleep medicine or melatonin irregularly, you may not be eligible to participate.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but it does exclude those who take sleep medicine or melatonin irregularly.

What prior data suggests that this sleep extension strategy is safe for heart failure patients?

Studies have shown that sleep coaching and sleep hygiene training are generally safe. People who have extended their sleep report positive health benefits without serious side effects. Sleep hygiene training improves sleep habits, such as setting a regular bedtime, and is safe and well-tolerated.

Research indicates that these methods avoid medication, reducing risks. Participants in similar studies have not reported significant negative effects. Sleep coaching and hygiene training are non-invasive, avoiding surgery or drugs, which limits potential risks. Overall, these methods are safe and aim to improve sleep and quality of life for those with heart failure. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about customized sleep coaching and sleep hygiene training for heart failure patients because these approaches aim to enhance sleep efficiency, which is not typically addressed by standard heart failure treatments. Unlike conventional therapies that focus on medications and lifestyle changes to manage symptoms, this strategy uses a gradual sleep extension technique to potentially improve heart function and overall health. By prioritizing better sleep, this method offers a novel way to support the heart's well-being, potentially providing benefits beyond traditional care methods.

What evidence suggests that this trial's treatments could be effective for heart failure with preserved ejection fraction?

Research has shown that better sleep can positively affect heart health, particularly for individuals with heart failure with preserved ejection fraction (HFpEF). This trial will explore a gradual sleep extension strategy combined with sleep hygiene training. Studies have found that extending sleep through personalized sleep coaching and good sleep habits can increase actual rest time in bed. Better sleep is linked to improved quality of life and reduced inflammation, which is crucial for managing HFpEF. Previous studies suggest these sleep strategies can enhance patients' well-being and daily functioning. Therefore, focusing on sleep might be a vital approach to addressing heart issues in HFpEF patients. ^{1 2 3 4 6}

Who Is on the Research Team?

Salvatore Carbone

Principal Investigator

Virginia Commonwealth University

Are You a Good Fit for This Trial?

This trial is for adults with heart failure who have preserved ejection fraction—a condition where the heart chamber pumps out a normal amount of blood. Participants should have poor sleep quality but can't join if they have certain conditions that might interfere with the study or their ability to follow sleep coaching.

Inclusion Criteria

Left ventricular ejection fraction >50% documented in the prior 12 months

Sleep efficiency <85% measured during the 1-week run-in phase

Habitual reported sleep duration ≤7 hours

Exclusion Criteria

I am unable to give consent for myself.

I have advanced kidney disease and am on dialysis.

I do not have severe heart conditions like angina or heart rhythm problems.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1 week

1 visit (in-person)

Run-in

Participants undergo a 1-week run-in phase to establish baseline sleep patterns using wearable devices and sleep journals

1 week

1 visit (in-person)

Treatment

Participants receive a gradual sleep extension strategy combined with sleep hygiene training to improve sleep efficiency

2 weeks

2 visits (in-person)

Follow-up

Participants are monitored for changes in sleep quality and efficiency using the Epworth Sleepiness Scale and Pittsburgh Sleep Quality questionnaire

1 week

1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Customized Sleep Coaching
• Sleep Hygiene Training

Trial Overview The study tests whether improving sleep through Sleep Hygiene Training and Customized Sleep Coaching can enhance life quality, physical function, and reduce inflammation in patients with this type of heart failure.

How Is the Trial Designed?

Group I: Gradual sleep extension strategy Experimental Treatment 2 Interventions

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

Who Is Running the Clinical Trial?

Virginia Commonwealth University

Lead Sponsor

Trials

732

Recruited

22,900,000+

Sleep Research Society Foundation (SRSF)

Collaborator

Trials

1

Recruited

20+

Published Research Related to This Trial

In a pilot study involving 32 heart failure patients, non-pharmacological interventions led to improvements in both sleep quality and health-related quality of life over 24 weeks, although these improvements were not statistically significant.

The study's findings suggest that while the interventions may be beneficial, further research with larger sample sizes is needed to confirm their effectiveness and determine the necessary statistical power for future trials.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Non-pharmacological interventions for sleep and quality of life: a randomized pilot study. Santos, MAD., Conceição, APD., Ferretti-Rebustini, REL., et al.[2023]

In a study of 22 patients with advanced heart failure, 96% reported poor sleep quality upon admission and during hospitalization, with 86% still experiencing poor sleep quality post-discharge.

Despite the high rates of poor sleep quality, participants reported improvements in sleep after discharge, suggesting that interventions to enhance sleep in the hospital and education for home sleep management could significantly benefit heart failure outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Sleep Quality in the Advanced Heart Failure ICU. Edmiston, EA., Hardin, HK., Dolansky, MA.[2023]

Short sleep duration is linked to an increased risk of chronic health issues like obesity, type 2 diabetes, and cardiovascular disease, highlighting the importance of adequate sleep for overall health.

While some studies suggest that extending sleep may improve health outcomes in individuals who typically get less sleep, more research is needed to determine if these benefits can effectively reverse the negative effects of chronic sleep deprivation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Sleep Extension in Short Sleepers: An Evaluation of Feasibility and Effectiveness for Weight Management and Cardiometabolic Disease Prevention. Pizinger, TM., Aggarwal, B., St-Onge, MP.[2019]

A 12-week tailored educational supportive care program significantly improved sleep quality and reduced daytime sleepiness in 84 patients with heart failure, compared to a control group that received routine care.

The intervention also helped maintain stable levels of anxiety and depression in the intervention group, while these scores worsened in the control group, highlighting the program's potential benefits for psychological well-being.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Tailored educational supportive care programme on sleep quality and psychological distress in patients with heart failure: A randomised controlled trial. Chang, YL., Chiou, AF., Cheng, SM., et al.[2017]

Sleep extension is a feasible intervention that can increase total sleep time by an average of 51 minutes, which may help improve sleep hygiene in free-living adults.

In individuals with pre-hypertension or Stage 1 hypertension, sleep extension significantly reduced both systolic and diastolic blood pressure, suggesting potential cardiovascular benefits for this group.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility of sleep extension and its effect on cardiometabolic parameters in free-living settings: a systematic review and meta-analysis of experimental studies. Zhu, B., Yin, Y., Shi, C., et al.[2022]

A study involving 92 adults with short sleep duration (average of 5:49 hours) found that 84% of participants were interested in interventions to increase their sleep, particularly using wrist-worn devices.

Participants with sleep disorders, such as insomnia, showed a higher interest in sleep extension interventions, indicating that wearable technology could be a promising solution for those struggling with sleep issues.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Predictors of Intervention Interest Among Individuals With Short Sleep Duration. Adkins, EC., DeYonker, O., Duffecy, J., et al.[2020]

In a study of 39 older adults with insomnia, combining sleep restriction therapy with sleep hygiene did not show significant differences in efficacy compared to sleep hygiene alone, suggesting that sleep hygiene may be effective on its own.

The study utilized wrist actigraphy and polysomnography to measure sleep outcomes, finding that actigraphic data correlated well with PSG results, indicating it could be a reliable method for assessing sleep in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An actigraphic comparison of sleep restriction and sleep hygiene treatments for insomnia in older adults. Friedman, L., Benson, K., Noda, A., et al.[2022]

Cognitive Behavioral Therapy for Insomnia (CBT-I) significantly improved insomnia severity, sleep quality, fatigue, and daytime sleepiness in adults with chronic heart failure over a one-year period, compared to a self-management education program.

The study involved 175 participants and demonstrated that CBT-I also enhanced physical function, as measured by the six-minute walk distance, indicating its effectiveness in managing sleep-related issues in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cognitive behavioral therapy for insomnia has sustained effects on insomnia, fatigue, and function among people with chronic heart failure and insomnia: the HeartSleep Study. Redeker, NS., Yaggi, HK., Jacoby, D., et al.[2022]

Sleep apnea is a common but often overlooked condition in heart failure patients, affecting 50% to 75% of this population, and significantly increases the risk of serious cardiovascular events and sudden death.

Emerging home-based technologies and device therapies offer promising new treatment options for managing sleep apnea in heart failure patients, potentially improving their health outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Novel Approaches to Sleep Apnea in Heart Failure. Jackson, GR., Singh, A.[2023]

In a study of 38 adults with sleep duration less than 7 hours, the combination of a Fitbit and coaching showed potential for improving sleep duration, although the results were not statistically significant compared to a self-management control group.

Coaching alone led to significant improvements in sleep-related impairment, highlighting that while all interventions were feasible and acceptable, the added accountability from coaching may enhance the effectiveness of sleep extension strategies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A feasibility study to understand the components of behavioral sleep extension. Baron, KG., Trela-Hoskins, SR., Duffecy, J., et al.[2023]

In a study of 53 healthy college students, extending sleep duration by at least 1 hour per night for one week significantly increased average sleep time by about 43 minutes, demonstrating that sleep extension is feasible for this population.

The sleep extension not only reduced daytime sleepiness but also led to a significant decrease in systolic blood pressure by 7 mmHg, indicating potential cardiovascular health benefits associated with improved sleep habits.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of sleep extension on sleep duration, sleepiness, and blood pressure in college students. Stock, AA., Lee, S., Nahmod, NG., et al.[2020]

Citations

1. withpower.com withpower.com/trial/phase-heart-failure-with-preserved-ejection-fraction-hfpef-7-2024-eb5de

Sleep Extension for Heart Failure · Info for Participants This trial is for adults with heart failure who have preserved ejection fraction—a condition where the heart chamber pumps out a normal amount of blood.

2. scholarscompass.vcu.edu scholarscompass.vcu.edu/etd/8135/

"Sleep extension to improve sleep efficiency and quality of life ... Sleep extension to improve sleep efficiency and quality of life in heart failure with preserved ejection fraction: the SLEEPHF pilot study ...

3. scholarscompass.vcu.edu scholarscompass.vcu.edu/threemt/27/

"Sleep Extension to Improve Sleep Quality of Life and Heart ... The Sleep-HF Pilot Study explores whether combining sleep coaching and sleep hygiene training can improve sleep quality, reduce inflammation, ...

4. drugtrialsformoney.com drugtrialsformoney.com/sleep-extension-to-improve-sleep-efficiency-and-qol-in-hf-with-preserved-ejection-fraction-the-sleep-hf-pilot-study/

Sleep Extension to Improve Sleep Efficiency and QoL in HF ... Conditions: Heart Failure With Preserved Ejection Fraction Interventions: Behavioral: Customized Sleep Coaching; Behavioral: Sleep Hygiene ...

5. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40110212/

rationale and design of the MyoMobile Study The MyoMobile study was designed to investigate the use of app-based coaching to improve PA in patients with HFpEF with a personalized, home-based intervention.

6. clinicaltrials.gov clinicaltrials.gov/study/NCT02848859

NCT02848859 | Improving Sleep for Healthy Hearts This is a pilot study randomizing patients with insomnia and coronary heart disease to either general sleep hygiene counseling and web-based cognitive ...