Sleep Extension for Vascular Health

(SAVHS Trial)

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: Auburn University

Must not be taking: Blood thinners

Disqualifiers: Hypertension, Obesity, Sleeping disorders, others

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

Compensation: Varies

Number of Visits: Unknown

60 Participants Needed

Trial Summary

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

The trial does not specify if you need to stop taking your current medications, but you cannot participate if you use blood thinners.

What data supports the idea that Sleep Extension for Vascular Health is an effective treatment?

The available research shows that Sleep Extension can help reduce blood pressure, which is a key factor in cardiovascular health. For example, the SLEPT study found that a web-delivered sleep intervention, which included sleep-hygiene education and therapy, was more effective in lowering blood pressure than standard care alone. Another study highlighted that extending sleep duration could improve heart health by addressing issues like hypertension. These findings suggest that Sleep Extension is a promising treatment for improving vascular health compared to not addressing sleep issues. ^{1 2 3 4 5}

What safety data exists for sleep extension treatments?

The available research on sleep extension, including studies on sleep hygiene and sleep interventions, suggests that while sleep extension can have positive effects on cardiometabolic health, there are limited randomized controlled trials specifically addressing safety. Some studies indicate potential benefits in selected patients with cardiovascular diseases, but others have shown no improvement or even worse outcomes. Overall, more research is needed to fully understand the safety and efficacy of sleep extension as a treatment. ^{1 2 4 5 6}

Is sleep extension a promising treatment for vascular health?

Yes, sleep extension is a promising treatment for vascular health. Research suggests that getting more sleep can improve heart health by reducing risks associated with cardiovascular diseases, like high blood pressure and other heart-related issues. By intentionally increasing sleep duration, people may improve their overall heart health and reduce the risk of developing serious heart conditions. ^{1 2 4 5 7}

What is the purpose of this trial?

Habitual short sleep duration (\< 7 hours/night) increases the risk of cardiovascular disease (CVD) and all-cause mortality. Yet most adults, especially emerging adults (i.e., 18-25 years) do not achieve the National Sleep Foundation recommendation of 7-9 hours of sleep each night. Additionally, the American Heart Association recently included sleep duration in the "Life's Essential 8". This recent development emphasizes the importance of sleep and the need to advance our understanding of how sleep impacts cardiometabolic health (CMH), particularly in emerging adults, a population whose CVD risk trajectory is malleable. Specifically, emerging adulthood is a critical age window when age-related loss of CMH accelerates. Based on my previous work and others, both self-reported and objective measures of poor sleep (e.g., duration, variability) are linked to early signs of elevated CVD risk in emerging adults, such as microvascular dysfunction and elevated central blood pressure (BP), which precede the development of hypertension.

Eligibility Criteria

This trial is for young adults aged 18-25 who usually sleep less than 7 hours a night and don't have lung, metabolic, liver, or heart diseases. They should not have severe food allergies, eating disorders, high blood pressure (over 140/80 mmHg), a BMI over 35 kg/m2, be on blood thinners or have a history of sleeping disorders.

Inclusion Criteria

I do not have any metabolic diseases.

You usually sleep less than 7 hours per night.

I do not have any lung diseases.

Exclusion Criteria

I have a history of sleeping disorders.

I am currently taking blood thinners.

You do not have serious food allergies or eating disorders.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Habitual Sleep

Participants will follow their normal sleep schedule for 2 weeks

2 weeks

Sleep Extension

Participants will extend their time in bed by one hour for 2 weeks while being monitored

2 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Sleep Extension

Trial Overview The study looks at whether increasing sleep to the recommended 7-9 hours can improve heart and metabolic health in young adults. It aims to understand how better sleep might lower the risk of cardiovascular disease by examining changes in participants' vascular function.

Participant Groups

Group I: Sleep extension Experimental Treatment 1 Intervention

Participants will extend their time in bed by one hour for 2 weeks while being monitored.

Group II: Habitual Sleep Active Control 1 Intervention

Participants will follow their normal sleep schedule for 2 weeks.

Who Is Running the Clinical Trial?

Auburn University

Lead Sponsor

Trials

81

Recruited

14,600+

Findings from Research

A web-delivered sleep intervention significantly improved sleep quality and psychosocial health in 134 participants with mild sleep impairment, but it did not lead to significant reductions in blood pressure over 8 weeks.

The intervention group showed notable improvements in various sleep quality measures and mental health indicators, but the change in 24-hour ambulatory systolic blood pressure was similar to the control group, indicating that while sleep quality improved, it did not translate to immediate cardiovascular benefits.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Sleep to Lower Elevated Blood Pressure: A Randomized Controlled Trial (SLEPT). McGrath, ER., Espie, CA., Power, A., et al.[2018]

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 6-week technology-assisted sleep extension intervention significantly improved total sleep time and reduced both systolic and diastolic blood pressure in adults with prehypertension or stage 1 hypertension, indicating its potential efficacy in managing these conditions.

Participants found the intervention enjoyable and engaged well, completing 90% of coaching sessions, which suggests that such technology-assisted approaches could be feasible and well-received for improving sleep and health outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Technology Assisted Behavior Intervention to Extend Sleep Among Adults With Short Sleep Duration and Prehypertension/Stage 1 Hypertension: A Randomized Pilot Feasibility Study. Baron, KG., Duffecy, J., Richardson, D., et al.[2023]

Patients with various cardiovascular diseases often experience poor sleep quality and duration, which are linked to worse cardiovascular outcomes, indicating that sleep issues should be addressed in treatment plans.

There is a complex, bidirectional relationship between sleep and cardiovascular diseases, suggesting that improving sleep could be a valuable target for treatment, although current studies show mixed results regarding survival benefits from sleep interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Sleep - the yet underappreciated player in cardiovascular diseases: A clinical review from the German Cardiac Society Working Group on Sleep Disordered Breathing. Spiesshoefer, J., Linz, D., Skobel, E., et al.[2023]

Recent research highlights the important connection between sleep and cardiovascular health, suggesting that better understanding of this relationship can lead to improved therapies.

Combining animal models with human trials can enhance scientific discovery and help address the global issues of insufficient sleep and cardiovascular disease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Sleep calibrates atherosclerotic cardiovascular disease. Cohen, O., Shah, NA., McAlpine, CS.[2023]

In a study involving 12 middle-aged adults, extending sleep duration to over 10 hours did not negatively affect blood pressure or arterial stiffness, suggesting safety in terms of cardiovascular health.

However, the study found that longer sleep duration improved microvascular function, as indicated by increased peak forearm vascular conductance and total excess blood flow, highlighting a potential benefit of extended sleep on vascular health.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of five nights of sleep extension on peripheral vascular function: a randomized crossover investigation into long sleep duration. Gonzales, JU., Clark, C., Anderson, T.[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]

References

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

Sleep to Lower Elevated Blood Pressure: A Randomized Controlled Trial (SLEPT). [2018]

2. 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]

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

Technology Assisted Behavior Intervention to Extend Sleep Among Adults With Short Sleep Duration and Prehypertension/Stage 1 Hypertension: A Randomized Pilot Feasibility Study. [2023]

4. England pubmed.ncbi.nlm.nih.gov

Sleep - the yet underappreciated player in cardiovascular diseases: A clinical review from the German Cardiac Society Working Group on Sleep Disordered Breathing. [2023]

5. England pubmed.ncbi.nlm.nih.gov

Sleep calibrates atherosclerotic cardiovascular disease. [2023]

6. Netherlands pubmed.ncbi.nlm.nih.gov

Effect of five nights of sleep extension on peripheral vascular function: a randomized crossover investigation into long sleep duration. [2023]

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]