Sleep Extension and Blood Pressure

Sleep Extension Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02929810
• Other study ID #: 16-000987
• Status: Completed
• Phase: N/A
• Start date: October 2016
• Est. completion date: September 7, 2023

Study information

• Verified date: February 2024
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 9
• Est. completion date: September 7, 2023
• Est. primary completion date: September 7, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Sleep Extension

Intervention

Behavioral:
• sleep extension

• sleep maintenance

Locations

Country	Name	City	State
United States	Mayo Clinic in Rochester	Rochester	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	change in 24-hour mean arterial pressure		8 weeks
Secondary	change in baroreflex sensitivity		8 weeks
Secondary	change in endothelial function		8 weeks
Secondary	change in insulin sensitivity		8 weeks

External Links

•   Mayo Clinic Clinical Trials