HELP-HY: Health Education and sLeep Program in HYpertension

Study Overview
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Brief Summary
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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).

Official Title
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HELP-HY: Health Education and sLeep Program in HYpertension

Conditions
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Prehypertension, Hypertension

Intervention / Treatment
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* Behavioral: Sleep Enhancement
* Behavioral: Health Education


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Sleep Enhancement<br> | Behavioral: Sleep Enhancement<br>* 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.<br>|
| Placebo Comparator: Health Education<br> | Behavioral: Health Education<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change in 48-hour mean arterial pressure | changes in ambulatory measure of blood pressure | 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| changes in 48-hour heart rate | changes in 24-hour heart rate | 8 weeks | 
| changes in baroreflex sensitivity | changes in baroreflex sensitivity | 8 weeks | 
| changes in endothelial function | changes in endothelial function | 8 weeks | 
| changes in renin | changes in renin | 8 weeks | 
| changes in angiotensin peptides | changes in angiotensin peptides | 8 weeks | 
| changes in aldosterone | changes in aldosterone | 8 weeks | 
| changes in insulin sensitivity | changes in insulin sensitivity | 8 weeks | 
| changes in cortisol | changes in cortisol | 8 weeks | 
| changes in body fat | changes in body fat | 8 weeks | 
| changes in catecholamines | changes in catecholamines | 8 weeks |