Sleep Restriction for High Blood Pressure

(SASE2 Trial)

Overseen By Rebecca Dileo

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: University of California, San Francisco

Must not be taking: Antidepressants, Anxiolytics, Beta-blockers

Disqualifiers: Obesity, Sleep disorders, Hypertension, others

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

Compensation: Varies

Number of Visits: 2

77 Participants Needed

Trial Summary

What is the purpose of this trial?

This study aims to to test effects of sleep loss on perceived discrimination and cardiovascular functioning as well as identify moderators of the racial discrimination and objective sleep link in a sample of 80 African Americans.

Will I have to stop taking my current medications?

Yes, if you are taking medications that affect sleep or heart function, like antidepressants, anxiety medications, sleep aids, or beta-blockers, you will need to stop taking them to participate in this trial.

What data supports the effectiveness of the treatment Sleep Restriction for High Blood Pressure?

Research shows that sleep restriction can raise blood pressure and heart rate, which suggests that managing sleep duration might help control high blood pressure. Studies have found that short sleep duration is linked to higher blood pressure and hypertension, especially in middle-aged adults and women. ^{1 2 3 4 5}

Is sleep restriction safe for humans?

Research shows that sleep restriction can raise blood pressure and heart rate, which may increase the risk of developing high blood pressure over time. It is important to consider these potential risks when evaluating the safety of sleep restriction. ^{1 2 3 5 6}

How does sleep restriction treatment differ from other treatments for high blood pressure?

Sleep restriction treatment is unique because it focuses on altering sleep patterns rather than using medication to manage high blood pressure. Unlike traditional treatments that often involve drugs, this approach examines the impact of sleep duration and quality on blood pressure, suggesting that improving sleep could be a novel way to help control hypertension. ^{1 2 3 4 7}

Research Team

Aric A Prather, PhD

Principal Investigator

University of California, San Francisco

Eligibility Criteria

This study is for English-speaking African Americans aged 18-64 who usually sleep between 10 PM and 12 AM, with a normal sleep duration of 6.5 to 8.5 hours confirmed by actigraphy and diary. Excluded are those over age 64, BMI of 40+, with clinical sleep disorders or on medications affecting sleep/cardiovascular function.

Inclusion Criteria

English speaking, able to provide informed consent

Self-reported bedtime between 10 PM and 12 AM for 5/7 nights for the past 3-months (stability to be confirmed by actigraphy and sleep diary)

Self-reported sleep duration of between 6.5 and 8.5 hours for 5/7 nights for the last month (duration to be confirmed by actigraphy and sleep diary)

Exclusion Criteria

Aged greater than 64 years (to minimize age-related differences in sleep quantity and architecture)

Body mass index of 40 or above (to exclude for obesity, which can impair physiologic recording and confound study outcomes)

Presence of any clinical sleep disorder, including insomnia and obstructive sleep apnea (OSA), as assessed by validated screening measure. OSA will also be assessed objectively during the Sleep Screening period

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Sleep Intervention

Participants are randomized to either total sleep restriction or normal sleep in the laboratory

1 night

1 overnight visit (in-person)

Social Experience Tasks

Participants undergo social interaction tasks including a digit span task, social evaluative speech task, and cooperative task with subtle negative evaluative feedback

1 day

1 visit (in-person)

Follow-up

Participants are monitored for changes in cardiovascular functioning and affect post-intervention

13 hours

Treatment Details

Interventions

• Sleep Restriction

Trial Overview The trial examines how restricted sleep affects perceptions of discrimination and cardiovascular health in African Americans. It will also explore factors that might influence the link between racial discrimination experiences and actual sleep patterns.

Participant Groups

Group I: Total Sleep Restriction Experimental Treatment 1 Intervention

Participants will experience a night of total sleep restriction and then undergo a social-rejection task in the morning.

Group II: Normal Sleep Active Control 1 Intervention

Participants will sleep in the laboratory for 8 hours and then undergo the same social-rejection paradigm as the experimental group to serve as a control comparison.

Who Is Running the Clinical Trial?

University of California, San Francisco

Lead Sponsor

Trials

2,636

Recruited

19,080,000+

National Heart, Lung, and Blood Institute (NHLBI)

Collaborator

Trials

3,987

Recruited

47,860,000+

Findings from Research

In a study involving 237 women, sleep restriction (reducing sleep by 1.5 hours per night for 6 weeks) was found to significantly increase systolic blood pressure and mean arterial pressure, indicating a potential cardiovascular risk associated with less sleep.

The study also revealed that psychological distress did not mediate the relationship between sleep restriction and blood pressure changes, suggesting that the effects of sleep on cardiovascular health may operate through mechanisms unrelated to stress.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mild sleep restriction increases 24-hour ambulatory blood pressure in premenopausal women with no indication of mediation by psychological effects. St-Onge, MP., Campbell, A., Aggarwal, B., et al.[2021]

Adequate quality sleep is linked to lower blood pressure and may help prevent and treat hypertension, as shown by various studies including experimental, epidemiological, and interventional research.

Short sleep duration is associated with higher blood pressure, particularly in middle-aged adults and women, suggesting that improving sleep quality and duration could be an effective strategy for managing hypertension.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A review of evidence for the link between sleep duration and hypertension. Gangwisch, JE.[2022]

In a study involving 15 healthy young men, sleep restriction to 5 hours per night led to a significant increase in daytime heart rate (HR) and systolic blood pressure (SBP) during recovery, indicating that the cardiovascular effects of sleep loss persist even after a short recovery period.

After two nights of recovery sleep, HR and SBP remained elevated compared to baseline levels, suggesting that longer recovery sleep may be necessary to fully restore cardiovascular function following multiple nights of sleep restriction.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Recovery Sleep After Sleep Restriction Is Insufficient to Return Elevated Daytime Heart Rate and Systolic Blood Pressure to Baseline Levels. Reichenberger, DA., Ness, KM., Strayer, SM., et al.[2023]

In a study comparing 62 subjects with resistant hypertension (RH) to 49 with controlled hypertension (CH) and 40 normotensive individuals, those with RH had significantly shorter sleep durations, averaging 33.8 minutes less than CH and 37.2 minutes less than normotensive subjects.

The findings indicate that reduced total and REM sleep times, along with lower sleep efficiency in RH patients, may contribute to the severity of hypertension, independent of obstructive sleep apnea (OSA).

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Independent association of drug-resistant hypertension to reduced sleep duration and efficiency. Friedman, O., Bradley, TD., Ruttanaumpawan, P., et al.[2022]

In a study of 5,910 adults aged 40 to 100, sleeping less than 6 hours per night was associated with a significantly higher risk of hypertension, with an adjusted odds ratio of 1.66 compared to those sleeping 7 to less than 8 hours.

Even sleeping slightly less than the recommended 7 to 8 hours (between 6 to 7 hours) increased the odds of hypertension, while sleeping more than 8 hours also showed a risk, indicating that both insufficient and excessive sleep can contribute to high blood pressure.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Association of usual sleep duration with hypertension: the Sleep Heart Health Study. Gottlieb, DJ., Redline, S., Nieto, FJ., et al.[2022]

References

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

Mild sleep restriction increases 24-hour ambulatory blood pressure in premenopausal women with no indication of mediation by psychological effects. [2021]

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

A review of evidence for the link between sleep duration and hypertension. [2022]

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

Recovery Sleep After Sleep Restriction Is Insufficient to Return Elevated Daytime Heart Rate and Systolic Blood Pressure to Baseline Levels. [2023]

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

Independent association of drug-resistant hypertension to reduced sleep duration and efficiency. [2022]

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

Association of usual sleep duration with hypertension: the Sleep Heart Health Study. [2022]

6. England pubmed.ncbi.nlm.nih.gov

The relationship of sleep duration and insomnia to risk of hypertension incidence: a meta-analysis of prospective cohort studies. [2022]

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

Effect of Sleep Disturbances on Blood Pressure. [2022]