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Completed

NCT Number: NCT03255746

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).

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Key information

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 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

Treatment and study plan

Sleep Enhancement

Behavioral

This regimen combines education and behavioral skills to enable prolonging sleep in chronically sleep deprived subjects so as to better meet participant's sleep needs. This intervention emphasizes plain language communication of cognitive behavioral therapy strategies for initiating and maintaining health behavior change, primarily through using brief action plans (time-limited, personally relevant, behavioral goal setting with confidence), and collaborative problem-solving. Coaching will be provided to modify daily routines and adhere to sleep hygiene practices to allow for extended time in bed.

Health Education

Behavioral

This is a placebo/attention control condition. Participants will receive health education based on NIH information. Number, duration, and frequency of sessions will be identical to those administered to the intervention group.

Primary outcomes

  1. change in 48-hour mean arterial pressure

    Time frame: 8 weeks

    changes in ambulatory measure of blood pressure

Secondary outcomes

  1. changes in 48-hour heart rate

    Time frame: 8 weeks

    changes in 24-hour heart rate

  2. changes in baroreflex sensitivity

    Time frame: 8 weeks

    changes in baroreflex sensitivity

  3. changes in endothelial function

    Time frame: 8 weeks

    changes in endothelial function

  4. changes in renin

    Time frame: 8 weeks

    changes in renin

  5. changes in angiotensin peptides

    Time frame: 8 weeks

    changes in angiotensin peptides

  6. changes in aldosterone

    Time frame: 8 weeks

    changes in aldosterone

  7. changes in insulin sensitivity

    Time frame: 8 weeks

    changes in insulin sensitivity

  8. changes in cortisol

    Time frame: 8 weeks

    changes in cortisol

  9. changes in body fat

    Time frame: 8 weeks

    changes in body fat

  10. changes in catecholamines

    Time frame: 8 weeks

    changes in catecholamines

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Collaborators

  • National Heart, Lung, and Blood Institute (NHLBI)

Registry information

Important dates

Study start
2018
Primary completion
2025
Study completion
2025
First posted
Aug 21, 2017
Registry last updated
Jul 16, 2026

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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