HELP-HY: Health Education and sLeep Program in HYpertension

Mayo Clinic

Status

Active, not recruiting

Conditions

Hypertension

Prehypertension

Treatments

Behavioral: Health Education

Behavioral: Sleep Enhancement

Study type

Interventional

Funder types

Other

NIH

Identifiers

NCT03255746

17-004044

R01HL134808 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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).

Enrollment

110 patients

Sex

All

Ages

18 to 65 years old

Volunteers

Accepts Healthy Volunteers

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