HELP-HY: Health Education and sLeep Program in HYpertension



Status:Recruiting
Conditions:High Blood Pressure (Hypertension)
Therapuetic Areas:Cardiology / Vascular Diseases
Healthy:No
Age Range:18 - 65
Updated:2/13/2019
Start Date:April 19, 2018
End Date:June 30, 2022
Contact:Carrie Witter
Email:CPLSLEEPEXT@mayo.edu
Phone:(507) 255-0492

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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).


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 ≤6.5 hours and voluntary prolongation of sleep when
circumstances allow

- Presence of prehypertension, Stage 1 hypertension, 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 >6.5 hours

- Excessive alcohol and/or excessive caffeine intake

- Currently on a diet and/or actively trying to lose weight

- History of drowsing driving

- Severe daytime sleepiness

- 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
We found this trial at
1
site
200 First Street SW
Rochester, Minnesota 55905
507-284-2511
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