HELP-HY: Health Education and sLeep Program in HYpertension

Overview

  • Study type

    Interventional
  • Study IDs

  • Describes the nature of a clinical study. Types include:

    • Observational study — observes people and measures outcomes without affecting results.
    • Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
    • Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
  • Site IRB
    • Rochester, Minnesota: 17-004044
    NCT ID: NCT03255746
    Sponsor Protocol Number: 17-004044

About this study

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).

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. If you need assistance understanding the eligibility criteria, please contact the study team.

See eligibility criteria

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 ≤6.5 hours and voluntary prolongation of sleep when circumstances allow (as indicated by napping and/or >45 min catch-up sleep during weekends or holidays[77]).
  • 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 >6.5 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 drowsy driving.
  • Severe daytime sleepiness (score >15 at the Epworth Sleepiness Scale[78]).
  • 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.

Participating Mayo Clinic locations

Study statuses change often. Please contact us for help.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Virend Somers, M.D., Ph.D.

Open for enrollment

Contact information:

Sleep and Cardiovascular Clinical Research Unit

CPL@mayo.edu