Sleep Restriction for High Blood Pressure

Overseen By Sabah Munir

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: Mayo Clinic

Must not be taking: Prescription medications, Melatonin

Disqualifiers: Hypertension, Diabetes, Insomnia, others

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

Compensation: Varies

Number of Visits: Unknown

44 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial investigates how reduced sleep affects individuals with parents who have high blood pressure compared to those with parents who have normal blood pressure. Participants will undergo both normal sleep and sleep restriction (partial sleep deprivation) in different phases. The trial suits healthy adults aged 18-35 who typically sleep 7-9 hours a night and have information about their parents' blood pressure. As an unphased trial, it offers a unique opportunity to contribute to understanding the impact of sleep on blood pressure risk factors.

Will I have to stop taking my current medications?

Yes, you will need to stop taking any regular prescription medications other than contraceptives to participate in this trial.

What prior data suggests that sleep restriction is safe for individuals with a family history of high blood pressure?

Research shows that sleep restriction, or not getting enough sleep, can have side effects. Some studies have found that short-term sleep restriction might raise blood pressure and cause other bodily changes, leading to increased daytime fatigue or difficulty focusing.

Participants in sleep restriction studies have reported physical changes, such as higher blood pressure and reduced ability to process sugar, which links to diabetes. Additionally, some studies suggest that insufficient sleep can increase the risk of health problems, including heart issues.

Effects vary from person to person. Some may find it harder to concentrate or feel more stressed. While these outcomes are possible, individual reactions differ. Those considering joining a study on sleep restriction should consult a healthcare provider to understand the risks and benefits. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores how sleep restriction might impact high blood pressure, which is a new angle compared to traditional methods like medication or lifestyle changes. Unlike standard treatments that usually involve drugs like ACE inhibitors or beta-blockers, this approach examines whether adjusting sleep patterns can naturally influence blood pressure. This investigation could reveal if managing sleep can be an effective, non-pharmaceutical strategy for controlling high blood pressure, offering a potentially safer and more accessible option for patients.

What evidence suggests that this trial's treatments could be effective for high blood pressure?

Research has shown that insufficient sleep can raise blood pressure. Studies suggest that poor sleep may elevate blood pressure, particularly when sleep quality is low. In some cases, inadequate sleep can cause sudden nighttime spikes in blood pressure. Other studies have found links between both mild and severe sleep deprivation and higher blood pressure. This trial will compare two sleep conditions: one group will undergo sleep restriction followed by normal sleep, while the other group will have normal sleep followed by sleep restriction. The researchers aim to determine if sleep limitation affects blood pressure differently in individuals whose parents have either high or normal blood pressure. ^{6 7 8 9 10}

Who Is on the Research Team?

Naima Covassin, Ph.D

Principal Investigator

Mayo Clinic

Are You a Good Fit for This Trial?

This trial is for healthy adults aged 18-35, nonsmokers with normal sleep patterns and no significant medical or psychiatric diseases. Participants must have both biological parents' hypertension history from specific records and not be on any drugs, including high caffeine or alcohol intake. Pregnant women, those with abnormal blood pressure or glucose levels, extreme physical activity habits, or poor kidney function are excluded.

Inclusion Criteria

I am a healthy adult between 18 and 35 years old.

Nonsmoker

Nonpregnant

Exclusion Criteria

Pregnant or lactating

I don't know if my biological parents had high blood pressure or I am adopted.

Use of tobacco, vaping, marijuana products or other drugs

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline

Participants undergo a 3-day/2-night baseline assessment to establish initial conditions

3 days

Inpatient visit

Experimental

Participants undergo a 5-day/5-night experimental phase with either sleep restriction or normal sleep

5 days

Inpatient visit

Recovery

Participants undergo a 2-day/2-night recovery phase following the experimental phase

2 days

Inpatient visit

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Normal sleep
• Partial sleep deprivation (sleep restriction)

Trial Overview The study examines the impact of partial sleep deprivation on individuals with a family history of high blood pressure versus those without such a history. It involves comparing the effects of reduced sleep to normal sleep in these two groups.

How Is the Trial Designed?

Group I: Study Sequence BA Experimental Treatment 2 Interventions

Normal sleep condition in the first period and sleep restriction condition in the second period. Each period will consist of a 10-day inpatient visit comprising a 3-day/2-night baseline, followed by a 5-day/5-night experimental phase, and a 2-day/2-night recovery phase.

Group II: Study Sequence AB Experimental Treatment 2 Interventions

Sleep restriction condition in the first period and normal sleep condition in the second period. Each period will consist of a 10-day inpatient visit comprising a 3-day/2-night baseline, followed by a 5-day/5-night experimental phase, and a 2-day/2-night recovery phase.

Who Is Running the Clinical Trial?

Mayo Clinic

Lead Sponsor

Trials

3,427

Recruited

3,221,000+

National Heart, Lung, and Blood Institute (NHLBI)

Collaborator

Trials

3,987

Recruited

47,860,000+

Published Research Related to This Trial

A systematic review of six randomized controlled trials involving 10 to 43 healthy adults found that sleep restriction did not significantly affect systolic or diastolic blood pressure, nor heart rate, indicating that short-term sleep deprivation may not pose immediate cardiovascular risks.

Preliminary evidence suggests that sleep restriction could influence the body's sympathetic and parasympathetic systems, but further studies with continuous monitoring are needed to confirm these effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Sleep Restriction Effects on BP: Systematic Review & Meta-analysis of RCTs. Hu, S., Jing, S., Gao, Y.[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 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]

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 10,308 British civil servants aged 35 to 55, short sleep duration (≤5 hours per night) was linked to a higher risk of hypertension, particularly in women, with an odds ratio of 1.72 compared to those sleeping 7 hours.

The association between short sleep duration and hypertension was less pronounced when accounting for other cardiovascular risk factors and psychiatric conditions, suggesting that sleep deprivation may have significant cardiovascular effects in women.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Gender-specific associations of short sleep duration with prevalent and incident hypertension: the Whitehall II Study. Cappuccio, FP., Stranges, S., Kandala, NB., et al.[2022]

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 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]

Citations

1. 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 ...

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

Effects of Experimental Sleep Restriction on Ambulatory ... We investigated the effects of prolonged sleep restriction on 24-hour ambulatory blood pressure (BP) and other cardiovascular measures in 20 healthy young ...

3. 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).

4. 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 ...

5. arteryresearch.biomedcentral.com arteryresearch.biomedcentral.com/articles/10.1016/j.artres.2017.06.003

Sleep restriction and its influence on blood pressure We observed, among restricted sleep individuals, sleepiness was significant increase at 4th and 7th day when compare to normal sleep individuals ...

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. mayo.edu mayo.edu/research/clinical-trials/cls-20568492

Sleep Restriction and Parental History of Hypertension The purpose of this study is to research the effects of partial sleep deprivation (sleep restriction) in a group of individuals whose parents have high blood ...

8. clinicaltrials.gov clinicaltrials.gov/study/NCT01433315

NCT01433315 | Physiologic Effects of Sleep Restriction The investigators hypothesize that sleep restriction will result in elevated blood pressure, inflammation, and neurocognitive deficits. Detailed Description.

9. 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 ...

10. ahajournals.org ahajournals.org/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, ...