Clinical trial NCT03255746: HELP-HY: Health Education and sLeep Program in HYpertension
Official title: HELP-HY: Health Education and sLeep Program in HYpertension
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Prehypertension
Hypertension
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
Collaborators: name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2017-08-21
Enrollment: 110
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).


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
* 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

Primary outcomes:
measure: change in 48-hour mean arterial pressure
timeFrame: 8 weeks
Secondary outcomes:
measure: changes in 48-hour heart rate
timeFrame: 8 weeks
measure: changes in baroreflex sensitivity
timeFrame: 8 weeks
measure: changes in endothelial function
timeFrame: 8 weeks
measure: changes in renin
timeFrame: 8 weeks
measure: changes in angiotensin peptides
timeFrame: 8 weeks
measure: changes in aldosterone
timeFrame: 8 weeks
measure: changes in insulin sensitivity
timeFrame: 8 weeks
measure: changes in cortisol
timeFrame: 8 weeks
measure: changes in body fat
timeFrame: 8 weeks
measure: changes in catecholamines
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic in Rochester
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Virend Somers, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: