HELP-HY: Health Education and sLeep Program in HYpertension
Study Details
Study Description
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).
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Sleep Enhancement
|
Behavioral: Sleep 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.
|
| Placebo Comparator: Health Education
|
Behavioral: Health 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.
|
Outcome Measures
Primary Outcome Measures
- change in 48-hour mean arterial pressure [8 weeks]
changes in ambulatory measure of blood pressure
Secondary Outcome Measures
- changes in 48-hour heart rate [8 weeks]
changes in 24-hour heart rate
- changes in baroreflex sensitivity [8 weeks]
changes in baroreflex sensitivity
- changes in endothelial function [8 weeks]
changes in endothelial function
- changes in renin [8 weeks]
changes in renin
- changes in angiotensin peptides [8 weeks]
changes in angiotensin peptides
- changes in aldosterone [8 weeks]
changes in aldosterone
- changes in insulin sensitivity [8 weeks]
changes in insulin sensitivity
- changes in cortisol [8 weeks]
changes in cortisol
- changes in body fat [8 weeks]
changes in body fat
- changes in catecholamines [8 weeks]
changes in catecholamines
Eligibility Criteria
Criteria
Inclusion criteria:
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Age: 18 to 65 (inclusive)
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Gender: both males and females
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Body mass index (BMI): 18.5-34.9 kg/m2
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Habitual sleep duration <7 hours and voluntary prolongation of sleep when circumstances allow
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Presence of prehypertension, Stage 1 hypertension, or currently taking antihypertensive medications
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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
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Not pregnant or breast feeding and not intending to become pregnant or breast feed
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Not a current smoker or tobacco user
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Ability to provide written informed consent.
Exclusion criteria:
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Vulnerable study populations will be excluded
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Pregnancy
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Smoking
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Shift-work
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Travel across >2 time zones in the previous month
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Presence of overt cardiovascular diseases, diabetes, chronic kidney disease, cancer, sleep/circadian disorders, psychiatric disorders
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If taking prescription medications for chronic conditions, change in therapy (type, frequency and/or dosage) over the previous month
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Sleep aids
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Habitual sleep duration ≥7 hours
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Excessive alcohol and/or excessive caffeine intake
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Currently on a diet and/or actively trying to lose weight
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History of drowsing driving
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Severe daytime sleepiness
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Current or previous (during the past 2 months) participation in other research studies at the discretion of study personnel
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Blood/plasma donation during the past 2 months
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Unwillingness or inability to adjust sleep schedule
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Mayo Clinic in Rochester | Rochester | Minnesota | United States | 55905 |
Sponsors and Collaborators
- Mayo Clinic
- National Heart, Lung, and Blood Institute (NHLBI)
Investigators
- Principal Investigator: Virend Somers, MD, PhD, Mayo Clinic
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 17-004044
- R01HL134808