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HELP-HY: Health Education and sLeep Program in HYpertension

HELP-HY: Health Education and sLeep Program in HYpertension

Recruiting
18-65 years
All
Phase N/A

Overview

Hypertension is the major risk factor for cardiovascular and cerebrovascular diseases worldwide. The escalating prevalence of inadequate sleep now parallels that of hypertension. Observational and experimental evidence favoring a causal relation between insufficient sleep and hypertension are particularly compelling - sleeping 6 hours or less per night is associated with a 20-32% higher probability of incident hypertension. Since sleep curtailment is largely voluntary, sleep deficiency may be corrected and the detrimental health consequences potentially reversed.

In this study the investigators aim to investigate the effects of 8 weeks of sleep enhancement/extension vs health education in prehypertensive and stage 1 hypertensive subjects who report habitual short sleep (6.5 hours/night).

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 and voluntary prolongation of sleep when circumstances allow
  • Presence of prehypertension, Stage 1 hypertension, or currently taking antihypertensive medications
  • 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
  • Shift-work
  • Travel across >2 time zones in the previous month
  • Presence of overt cardiovascular diseases, diabetes, chronic kidney disease, cancer, sleep/circadian disorders, psychiatric disorders
  • If taking prescription medications for chronic conditions, change in therapy (type, frequency and/or dosage) over the previous month
  • Sleep aids
  • Habitual sleep duration 7 hours
  • Excessive alcohol and/or excessive caffeine intake
  • Currently on a diet and/or actively trying to lose weight
  • History of drowsing driving
  • Severe daytime sleepiness
  • Current or previous (during the past 2 months) participation in other research studies at the discretion of study personnel
  • Blood/plasma donation during the past 2 months
  • Unwillingness or inability to adjust sleep schedule

Study details
    Vascular Diseases
    Vascular Diseases
    Hypertension
    high blood pressure (hypertension)
    high blood pressure (hypertension - pediatric)
    diabetes and hypertension
    Prehypertension
    high blood pressure (hypertension)
    diabetes and hypertension
    high blood pressure (hypertension - pediatric)

NCT03255746

Mayo Clinic

19 February 2024

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