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OpenTrials
Completed

NCT Number: NCT02929810

Sleep Extension and Blood Pressure

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.

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Key information

Conditions

Sleep Extension

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Sleep Extension

Behavioral

sleep maintenance

Behavioral

Primary outcomes

  1. change in 24-hour mean arterial pressure

    Time frame: 8 weeks

Secondary outcomes

  1. change in baroreflex sensitivity

    Time frame: 8 weeks

  2. change in endothelial function

    Time frame: 8 weeks

  3. change in insulin sensitivity

    Time frame: 8 weeks

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2023
Study completion
2023
First posted
Oct 11, 2016
Registry last updated
Feb 6, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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