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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how sleep loss affects feelings of discrimination and heart health. Participants will either sleep normally or experience sleep restriction (also known as sleep deprivation) to observe its impact on reactions to social situations. The study specifically seeks African American individuals who typically sleep between 6.5 and 8.5 hours a night and go to bed between 10 PM and 12 AM. The researchers aim to better understand the connection between sleep and experiences of discrimination. As an unphased study, this research provides a unique opportunity to contribute to understanding the intersection of sleep, discrimination, and heart health.

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 prior data suggests that sleep restriction is safe for participants?

Research has shown that insufficient sleep can cause several short-term changes in the body. One study found that just one night of limited sleep made participants feel much sleepier the next day. Other studies have indicated that inadequate sleep can lead to higher blood pressure and impair the body's ability to manage sugar levels, potentially affecting energy and mood.

However, these changes typically don't last long and often return to normal once regular sleep resumes. While insufficient sleep can cause these temporary effects, it doesn't involve medication or medical procedures, generally posing fewer risks than other treatments. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about exploring sleep restriction for high blood pressure because it offers a completely different approach compared to the usual medications and lifestyle changes. Unlike drugs that aim to lower blood pressure by targeting the cardiovascular system directly, this method explores the impact of sleep patterns on blood pressure regulation. The unique feature of this approach is its focus on behavioral intervention, which could potentially provide a non-pharmacological option with fewer side effects. By understanding how sleep restriction affects blood pressure, scientists hope to uncover new insights into managing hypertension through sleep management.

What evidence suggests that sleep restriction is effective for high blood pressure?

Research has shown that insufficient sleep can raise blood pressure. In this trial, participants will be assigned to different sleep conditions. One group will undergo total sleep restriction, which studies have found noticeably increases blood pressure. Another group will maintain normal sleep, serving as a control comparison. Overall, insufficient sleep clearly increases blood pressure, potentially affecting heart health. ^{4 6 7 8 9}

Who Is on the Research Team?

Aric A Prather, PhD

Principal Investigator

University of California, San Francisco

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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 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 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 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]

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7946733/

The Effect of Sleep Disturbances on Blood Pressure - PMC Intervention studies demonstrate that mild and severe sleep restriction are associated with higher BP. Rotating and night shift work are associated with ...

2. ahajournals.org ahajournals.org/doi/10.1161/HYPERTENSIONAHA.121.17622

Effects of Experimental Sleep Restriction on Ambulatory ... This study shows that experimental sleep restriction causes elevation in ambulatory blood pressure and activation of multiple cardiovascular ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8829775/

The association between sleep deprivation and arterial ... It was found an increase in blood pressure on the night of sleep deprivation, suggesting a possible causality with an acute increase in blood pressure depending ...

4. journals.physiology.org journals.physiology.org/doi/10.1152/ajpheart.00606.2024

Partial sleep restriction and blood pressure during exercise There is evidence that partial sleep restriction (PSR) leads to increased 24-h blood pressure, especially when sleep quality is poor (2).

5. sciencedirect.com sciencedirect.com/science/article/pii/S1087079224000443

Impact of one night of sleep restriction on sleepiness and ... Results revealed a significant increase in subjective sleepiness following one night of sleep restriction (Standardized Mean Difference (SMD) = 0.986, p < 0.001) ...

6. ncbi.nlm.nih.gov ncbi.nlm.nih.gov/books/NBK19961/

Extent and Health Consequences of Chronic Sleep Loss and ... Sleep loss and sleep disorders have been associated with a wide range of deleterious health consequences including an increased risk of hypertension, diabetes, ...

7. jcsm.aasm.org jcsm.aasm.org/doi/10.5664/jcsm.26918

Behavioral and Physiological Consequences of Sleep ... Short-term sleep restriction results in a number of abnormal physiologic changes, including reduced glucose tolerance,67 increased blood pressure,68 activation ...

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC1978335/

Behavioral and Physiological Consequences of Sleep ... Short-term sleep restriction results in a number of abnormal physiologic changes, including reduced glucose tolerance, increased blood pressure, activation of ...

9. ahajournals.org ahajournals.org/doi/10.1161/JAHA.124.035132?doi=10.1161/JAHA.124.035132

Short Sleep Duration and Hypertension: A Double Hit for ... Cohort studies consistently show that short sleep duration is associated with an increased risk of hypertension, and cardiovascular disease, ...