CClinicalTrials.gg
CompletedNCT03255746Updated Jul 16, 2026

HELP-HY: Health Education and sLeep Program in HYpertension

An interventional study of Sleep Enhancement and Health Education in Prehypertension and Hypertension, sponsored by Mayo Clinic. Completed at 1 site in United States. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-07-16.

Sponsored by Mayo Clinic · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
110
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study summary

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).

02

Conditions studied

  • Prehypertension
  • Hypertension
03

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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
04

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Investigator, Outcomes assessor)
Enrollment
110 participants (actual)

Study arms

  • Experimental
    Sleep Enhancement

    Behavioral: Sleep Enhancement

  • Placebo comparator
    Health Education

    Behavioral: Health Education

Interventions

  • BehavioralSleep Enhancement

    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.

  • BehavioralHealth Education

    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.

05

What researchers measure

Primary outcomes

  1. change in 48-hour mean arterial pressure

    changes in ambulatory measure of blood pressure

    Time frame: 8 weeks

Secondary outcomes

  1. changes in 48-hour heart rate

    changes in 24-hour heart rate

    Time frame: 8 weeks

  2. changes in baroreflex sensitivity

    changes in baroreflex sensitivity

    Time frame: 8 weeks

  3. changes in endothelial function

    changes in endothelial function

    Time frame: 8 weeks

  4. changes in renin

    changes in renin

    Time frame: 8 weeks

  5. changes in angiotensin peptides

    changes in angiotensin peptides

    Time frame: 8 weeks

  6. changes in aldosterone

    changes in aldosterone

    Time frame: 8 weeks

  7. changes in insulin sensitivity

    changes in insulin sensitivity

    Time frame: 8 weeks

  8. changes in cortisol

    changes in cortisol

    Time frame: 8 weeks

  9. changes in body fat

    changes in body fat

    Time frame: 8 weeks

  10. changes in catecholamines

    changes in catecholamines

    Time frame: 8 weeks

06

Study locations

1 site
  • Mayo Clinic in Rochester
    Rochester, Minnesota 55905, United States
07

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT03255746
Lead sponsor
Mayo Clinic
Collaborators
National Heart, Lung, and Blood Institute (NHLBI)
Responsible party
Virend Somers, MD, PhD (Professor of Medicine, Mayo Clinic) — Principal investigator
First posted
Aug 21, 2017
Start date
Apr 19, 2018
Primary completion
Mar 20, 2025
Completion
Mar 20, 2025
Last update
Jul 16, 2026

Study contacts

Virend Somers, MD, PhD
principal investigator · Mayo Clinic

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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