Status:
ACTIVE_NOT_RECRUITING
HELP-HY: Health Education and sLeep Program in HYpertension
Lead Sponsor:
Mayo Clinic
Collaborating Sponsors:
National Heart, Lung, and Blood Institute (NHLBI)
Conditions:
Prehypertension
Hypertension
Eligibility:
All Genders
18-65 years
Phase:
NA
Brief 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 exp...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
April 19 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2025
Estimated Enrollment :
110 Patients enrolled
Trial Details
Trial ID
NCT03255746
Start Date
April 19 2018
End Date
December 1 2025
Last Update
March 4 2025
Active Locations (1)
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1
Mayo Clinic in Rochester
Rochester, Minnesota, United States, 55905