NCT03255746Completed
HELP-HY: Health Education and sLeep Program in HYpertension
Source: ClinicalTrials.gov · Last updated 16 Jul 2026
Brief summary (registry, in English)
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).
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 110 (actual)
- First submitted
- 8 Aug 2017
- Start date
- 19 Apr 2018
- Primary completion date
- 20 Mar 2025
- Lead sponsor
- Mayo Clinic
- Diseases
- High blood pressure
- NCT number
- NCT03255746
What you commit to
- Study type: Interventional
- Participants enrolled: 110
- From 19 Apr 2018 to the primary completion date, 20 Mar 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Travel across \>2 time zones in the previous month
- If taking prescription medications for chronic conditions, change in therapy (type, frequency and/or dosage) over the previous month
- Currently on a diet and/or actively trying to lose weight
- Current or previous (during the past 2 months) participation in other research studies at the discretion of study personnel
Other illness
- Presence of overt cardiovascular diseases, diabetes, chronic kidney disease, cancer, sleep/circadian disorders, psychiatric disorders
- History of drowsing driving
Other
- Vulnerable study populations will be excluded
- Pregnancy
- Smoking
- Shift-work
- 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)
- Severe daytime sleepiness (score \>15 at the Epworth Sleepiness Scale)
- Blood/plasma donation during the past 2 months
- Unwillingness or inability to adjust sleep schedule
Who the study is looking for
- 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.
Age in the registry: 18 years to 65 years · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Mayo Clinic in Rochester Coordinator of this site? Confirm its status | Rochester | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.