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

17 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

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 data supports the idea that Sleep Extension for Heart Failure is an effective treatment?

The available research shows that non-drug treatments, like Sleep Extension for Heart Failure, can improve sleep quality and reduce psychological distress in patients with heart failure. One study found that educational programs helped improve sleep quality. Another study showed that cognitive behavioral therapy for insomnia had lasting positive effects on sleep and reduced fatigue in heart failure patients. These findings suggest that Sleep Extension for Heart Failure can be an effective way to help patients sleep better and feel less tired. ^{1 2 3 4 5}

What data supports the effectiveness of this treatment for heart failure?

Research shows that non-drug treatments like cognitive behavioral therapy for insomnia can improve sleep quality and reduce fatigue in people with heart failure. Educational programs and sleep self-management have also been found to enhance sleep quality and reduce psychological distress in heart failure patients. ^{1 2 3 4 5}

What safety data exists for sleep extension therapy?

The existing research on sleep extension therapy, including studies on its feasibility and effects on cardiometabolic health, suggests that it may improve health outcomes like blood pressure and cardiometabolic risk factors. However, the evidence is still in the early stages, and more large-scale studies are needed to fully understand its safety and effectiveness. ^{6 7 8 9 10}

Is sleep extension therapy safe for humans?

Current research suggests that sleep extension therapy is generally safe for humans, as it aims to increase sleep duration, which is associated with improved health outcomes. However, more large-scale studies are needed to fully understand its long-term safety and effects. ^{6 7 8 9 10}

Is the treatment Customized Sleep Coaching, Sleep Hygiene Training a promising treatment for heart failure?

Yes, Customized Sleep Coaching and Sleep Hygiene Training, which are part of sleep extension therapies, show promise as they may help improve heart health by increasing sleep duration. Studies suggest that getting more sleep can improve heart-related health issues. ^{6 7 8 9 11}

How does the treatment 'Customized Sleep Coaching' differ from other treatments for heart failure?

Customized Sleep Coaching is unique because it focuses on extending sleep duration as a behavioral intervention to improve heart health, using tools like wearable sleep trackers and personalized coaching. Unlike traditional treatments for heart failure, which often involve medication or lifestyle changes, this approach targets sleep as a modifiable lifestyle factor to potentially reduce cardiometabolic risks. ^{6 7 8 9 11}

Research Team

Salvatore Carbone

Principal Investigator

Virginia Commonwealth University

Eligibility Criteria

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

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)

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

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]

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]

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]

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]

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]

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]

References

1. England 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. [2017]

2. Brazil pubmed.ncbi.nlm.nih.gov

Non-pharmacological interventions for sleep and quality of life: a randomized pilot study. [2023]

3. United States 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. [2022]

4. United States pubmed.ncbi.nlm.nih.gov

Sleep Quality in the Advanced Heart Failure ICU. [2023]

5. United States pubmed.ncbi.nlm.nih.gov

Novel Approaches to Sleep Apnea in Heart Failure. [2023]

6. United States pubmed.ncbi.nlm.nih.gov

Predictors of Intervention Interest Among Individuals With Short Sleep Duration. [2020]

7. Switzerland pubmed.ncbi.nlm.nih.gov

Sleep Extension in Short Sleepers: An Evaluation of Feasibility and Effectiveness for Weight Management and Cardiometabolic Disease Prevention. [2019]

8. Netherlands pubmed.ncbi.nlm.nih.gov

A feasibility study to understand the components of behavioral sleep extension. [2023]

9. England 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. [2022]

10. United States pubmed.ncbi.nlm.nih.gov

Effects of sleep extension on sleep duration, sleepiness, and blood pressure in college students. [2020]

11. United States pubmed.ncbi.nlm.nih.gov

An actigraphic comparison of sleep restriction and sleep hygiene treatments for insomnia in older adults. [2022]