Sleep Extension and Blood Pressure

Not Applicable

Completed

• Conditions: Sleep Extension
• Interventions: Behavioral: sleep maintenance; Behavioral: sleep extension

• Registration Number: NCT02929810
• Lead Sponsor: Mayo Clinic

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-10
• Study First Submitted: 2016-10-09
• Study First Submitted QC: 2016-10-09
• Study First Posted: 2016-10-11
• Primary Completion: 2023-09-07
• Study Completion: 2023-09-07
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-05
• Last Update Posted: 2024-02-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 9

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
sleep maintenance	sleep maintenance	-
sleep extension	sleep extension	-

Primary Outcome Measures

Name	Time	Method
change in 24-hour mean arterial pressure	8 weeks

Secondary Outcome Measures

Name	Time	Method
change in endothelial function	8 weeks
change in insulin sensitivity	8 weeks
change in baroreflex sensitivity	8 weeks

Trial Locations

Locations (1)

Mayo Clinic in Rochester; 🇺🇸 Rochester, Minnesota, United States