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Sleep Extension and Blood Pressure

Lowering Blood Pressure by Sleep Extension: a Randomized, Controlled Trial

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02929810
Enrollment
9
Registered
2016-10-11
Start date
2016-10-31
Completion date
2023-09-07
Last updated
2024-02-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Sleep Extension

Brief summary

Emerging evidence suggests that approximately 30% of the US adult population sleeps less than 7 hours per night, and those who do exhibit 20-52% enhanced risk to develop cardiovascular diseases and particularly hypertension. Since sleep curtailment is largely voluntary, sleep deficiency can be corrected and its detrimental health consequences potentially reversed. The purpose of the present proposal is to investigate the cardiovascular and metabolic effects of sleep extension in prehypertensive and stage 1 hypertensive subjects who report habitual short sleep.

Interventions

BEHAVIORALsleep extension
BEHAVIORALsleep maintenance

Sponsors

Mayo Clinic
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes

Inclusion criteria

* Age: 18 to 65 (inclusive) * Gender: both males and females * Body mass index (BMI): 18.5-34.9 kg/m2 * Habitual sleep duration: \<7 hours * Presence of either: * Prehypertension: office systolic BP (SBP) 120-139 mmHg and/or diastolic BP (DBP) 80- 89 mmHg; * Stage 1 hypertension: office SBP 140-159 mmHg and/or DBP 90-99 mmHg * Either on no prescription medications (other than oral contraceptive pills, or intrauterine devices) or on stable medical regimen for at least 1 month, if taking prescription medications for chronic conditions * Not pregnant or breast feeding and not intending to become pregnant or breast feed * Not a current smoker or tobacco user * Ability to provide written informed consent

Exclusion criteria

* Vulnerable study populations will be excluded * Pregnancy * Smoking * Presence of overt cardiovascular diseases, diabetes, chronic kidney disease, cancer, sleep disorders, psychiatric disorders * If taking prescription medications for chronic conditions, change in therapy (type, frequency and/or dosage) over the previous month * Habitual sleep duration ≥7 hours * Excessive alcohol (≥15 drinks/week in men and ≥8 drinks/week in women) and/or excessive caffeine intake (\>400 mg) * Currently on a diet and/or actively trying to lose weight * Currently or previously (during the past 2 months) participation in any other research study at the discretion of study personnel * Blood/plasma donation during the past 2 months * Unwillingness or inability to adjust sleep schedule.

Design outcomes

Primary

MeasureTime frame
change in 24-hour mean arterial pressure8 weeks

Secondary

MeasureTime frame
change in baroreflex sensitivity8 weeks
change in endothelial function8 weeks
change in insulin sensitivity8 weeks

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026