Sleep Extension for High Blood Pressure

Overseen By Sumayya Shurovi

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Columbia University

Must not be taking: Prescription sleep aides

Disqualifiers: Pregnancy, ESRD, OSA, insomnia, others

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

Compensation: Varies

Number of Visits: 9

Duration: 8 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines how increased sleep affects blood pressure during sleep. Participants will receive either advice on sleep hygiene (good sleep habits) or general sleep education over eight weeks. The goal is to determine if better sleep can lower blood pressure. This trial suits English-speaking adults who sleep less than 7 hours a night. As an unphased trial, it provides a unique opportunity to contribute to understanding sleep's impact on health.

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

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the study team to get a clear answer.

What prior data suggests that this sleep hygiene/extension intervention is safe for managing blood pressure?

Research has shown that improving sleep habits and getting more sleep is generally safe. Studies have found that better sleep can help lower blood pressure. For instance, one study discovered that just one night of extra sleep significantly reduced morning blood pressure in adults. This indicates the treatment is not only effective but also easy to manage.

No serious side effects have been reported from getting more sleep. This is likely because the approach uses simple methods like education and monitoring instead of medication. Since this study doesn't involve testing a new drug or device, it is considered "Not Applicable" in terms of phases, indicating minimal safety concerns due to the low-risk methods.

Overall, participating in sleep improvement programs is expected to be a safe choice, focusing on natural and behavioral changes to boost health. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Sleep Hygiene/Extension Intervention because it offers a non-pharmacological approach to managing high blood pressure, unlike the typical reliance on medications like ACE inhibitors or beta-blockers. This treatment focuses on improving and extending sleep, which could naturally lower blood pressure by addressing sleep as a fundamental health component. Additionally, this approach is accessible, involving educational sessions and weekly support, making it a potentially cost-effective and sustainable option for long-term blood pressure management.

What evidence suggests that sleep hygiene/extension intervention might be an effective treatment for high blood pressure?

This trial will compare a Sleep Hygiene/Extension Intervention with a Control Condition to assess their effects on blood pressure. Research has shown that getting more sleep can help lower blood pressure. One study found that just one night of better sleep led to a noticeable drop in morning blood pressure, indicating that more sleep can help maintain blood pressure control. Another study tested a program designed to extend sleep duration and found it increased sleep time, positively affecting blood pressure. Reviews also suggest that more sleep could improve blood pressure management. Overall, improving sleep habits appears promising for managing blood pressure levels. ^{2 5 6 7 8}

Who Is on the Research Team?

Marwah Abdalla, MD, MPH

Principal Investigator

Columbia University

Are You a Good Fit for This Trial?

This trial is for English-speaking adults over 18 who sleep less than 7 hours a night. It's not suitable for those with arm circumference >50 cm, end-stage renal disease, high risk of sleep apnea or insomnia, depression, perimenopausal women with hot flashes, or if pregnant/planning to be within the study period.

Inclusion Criteria

You sleep less than 7 hours per night, as reported by yourself every day.

Exclusion Criteria

You have a high risk of depression based on a questionnaire called the PHQ-8.

I have a high risk of insomnia or have used prescription sleep aids.

You have swelling in your arm or cannot wear a device for a certain amount of time.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo an 8-week sleep hygiene/extension intervention or control condition with weekly phone or Zoom calls, sleep tracking, and monitoring

8 weeks

8 visits (virtual)

Follow-up

Participants are monitored for changes in blood pressure and heart rate variability after the intervention

1 week

1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Control care
• Sleep hygiene/extension intervention

Trial Overview

The study compares an 8-week program designed to improve sleep habits and extend sleep time against usual care to see how it affects blood pressure during sleep.

How Is the Trial Designed?

Group I: Sleep Hygiene/Extension Intervention Experimental Treatment 1 Intervention

Participants with short sleep duration will receive a 60-minute educational session on sleep hygiene/extension. Over an 8-week period, participants will receive weekly phone or Zoom video calls from the Educational Research Coordinator to review additional materials including handouts and/or complete questionnaires about sleep. Participants will undergo sleep tracking/monitoring during the 8-week period, and repeat BP/heart rate monitoring for 24 hours after the 8-week period.

Group II: Control Condition Active Control 1 Intervention

Participants with short sleep duration will receive a 60-minute educational session on sleep physiology. Over an 8-week period, participants will receive weekly phone or Zoom video calls from the Educational Research Coordinator to review additional materials including handouts. Participants will undergo sleep tracking/monitoring during the 8-week period, and repeat BP/heart rate monitoring for 24 hours after the 8-week period.

Who Is Running the Clinical Trial?

Columbia University

Lead Sponsor

Trials

1,529

Recruited

2,832,000+

National Institutes of Health (NIH)

Collaborator

Trials

2,896

Recruited

8,053,000+

National Heart, Lung, and Blood Institute (NHLBI)

Collaborator

Trials

3,987

Recruited

47,860,000+

Citations

1.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC11503376/

The Effect of Acute Sleep Extension on Blood Pressure Is ...

We observed morning blood pressure to be significantly reduced after one night of sleep extension in adults who had improved sleep efficiency. ...

2.

trialsjournal.biomedcentral.com

trialsjournal.biomedcentral.com/articles/10.1186/s13063-023-07658-6

a randomized controlled study of a behavioral sleep extension ...

The objective of this study is to test the effects of a behavioral sleep extension intervention on sleep duration, blood pressure, and other measures of ...

3.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC8730491/

Sleep Duration and Hypertension: Epidemiological Evidence ...

This review discusses the effects of sleep restriction and extension on blood pressure regulation, along with common clinical manifestations.

4.

clinicaltrials.gov

clinicaltrials.gov/study/NCT05062161

Sleep Duration and Blood Pressure During Sleep

The investigator will examine the effect of an 8-week sleep hygiene/extension intervention vs. control on sleep BP. Detailed Description. Short sleep duration ( ...

5.

ahajournals.org

ahajournals.org/doi/10.1161/HYPERTENSIONAHA.120.14479

Effect of Sleep Disturbances on Blood Pressure

These data demonstrate that repeated exposure to shortened sleep reduces BP dipping, despite intermittent catch-up sleep. Whether frequent ...

6.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC2913764/

Sleep and Hypertension - PMC - PubMed Central - NIH

Large prospective studies have demonstrated that nocturnal BP is a better predictor of cardiovascular risk than is daytime BP. In the Dublin Outcome Study, ...

7.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/37817267/

a randomized controlled study of a behavioral sleep extension ...

The primary outcome is sleep duration at 8 weeks, and the secondary outcome is blood pressure at 8 weeks. Discussion: The results of this study will determine ...

8.

mdpi.com

mdpi.com/2624-5175/6/4/36

The Effect of Acute Sleep Extension on Blood Pressure Is ...

We observed morning blood pressure to be significantly reduced after one night of sleep extension in adults who had improved sleep efficiency.