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HELP-HY: Health Education and sLeep Program in HYpertension
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).
Conditions:
🦠 Prehypertension 🦠 Hypertension
🗓️ Study Start (Actual) 19 April 2018
🗓️ Primary Completion (Estimated) 30 June 2024
✅ Study Completion (Estimated) 30 June 2024
👥 Enrollment (Estimated) 80
🔬 Study Type INTERVENTIONAL
📊 Phase NA
Locations:
📍 Rochester, Minnesota, United States

📋 Eligibility Criteria

Description

    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 (as indicated by napping and/or \>45 min catch-up sleep during weekends or holidays)
    • * Presence of 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 ) , 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 (\>14 drinks/week in men and \>7 drinks/week in women) and/or excessive caffeine intake (\>400 mg)
    • * Currently on a diet and/or actively trying to lose weight
    • * History of drowsing driving
    • * Severe daytime sleepiness (score \>15 at the Epworth Sleepiness Scale)
    • * 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
Ages Eligible for Study: 18 Years to 65 Years (ADULT, OLDER_ADULT)
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: Yes

🗓️ Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

  • First Submitted 8 August 2017
  • First Submitted that Met QC Criteria 16 August 2017
  • First Posted 21 August 2017

Study Record Updates

  • Last Update Submitted that Met QC Criteria 2 August 2023
  • Last Update Posted 3 August 2023
  • Last Verified August 2023
I'm interested ...!!