HELP-HY: Health Education and sLeep Program in HYpertension
Overview
- Phase
- Not Applicable
- Intervention
- Sleep Enhancement
- Conditions
- Prehypertension
- Sponsor
- Mayo Clinic
- Enrollment
- 110
- Locations
- 1
- Primary Endpoint
- change in 48-hour mean arterial pressure
- Status
- Active, not recruiting
- Last Updated
- 3 months ago
Overview
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 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).
Investigators
Virend Somers, MD, PhD
Professor of Medicine
Mayo Clinic
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 \<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
- •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
Arms & Interventions
Sleep Enhancement
Intervention: Sleep Enhancement
Health Education
Intervention: Health Education
Outcomes
Primary Outcomes
change in 48-hour mean arterial pressure
Time Frame: 8 weeks
changes in ambulatory measure of blood pressure
Secondary Outcomes
- changes in endothelial function(8 weeks)
- changes in cortisol(8 weeks)
- changes in catecholamines(8 weeks)
- changes in angiotensin peptides(8 weeks)
- changes in baroreflex sensitivity(8 weeks)
- changes in 48-hour heart rate(8 weeks)
- changes in renin(8 weeks)
- changes in aldosterone(8 weeks)
- changes in insulin sensitivity(8 weeks)
- changes in body fat(8 weeks)