HELP-HY: Health Education and sLeep Program in HYpertension

Not Applicable

Active, not recruiting

• Conditions: Hypertension; Prehypertension
• Interventions: Behavioral: Sleep Enhancement; Behavioral: Health Education

• Registration Number: NCT03255746
• Lead Sponsor: Mayo Clinic

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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-08-08
• Study First Submitted QC: 2017-08-16
• Study First Posted: 2017-08-21
• Study Start: 2018-04-19
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-03
• Last Update Posted: 2025-03-25
• Primary Completion: 2025-12
• Study Completion: 2025-12

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 110

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Sleep Enhancement	Sleep Enhancement	-
Health Education	Health Education	-

Primary Outcome Measures

Name	Time	Method
change in 48-hour mean arterial pressure	8 weeks	changes in ambulatory measure of blood pressure

Secondary Outcome Measures

Name	Time	Method
changes in angiotensin peptides	8 weeks	changes in angiotensin peptides
changes in endothelial function	8 weeks	changes in endothelial function
changes in cortisol	8 weeks	changes in cortisol
changes in catecholamines	8 weeks	changes in catecholamines
changes in baroreflex sensitivity	8 weeks	changes in baroreflex sensitivity
changes in 48-hour heart rate	8 weeks	changes in 24-hour heart rate
changes in renin	8 weeks	changes in renin
changes in aldosterone	8 weeks	changes in aldosterone
changes in insulin sensitivity	8 weeks	changes in insulin sensitivity
changes in body fat	8 weeks	changes in body fat

Trial Locations

Locations (1)

Mayo Clinic in Rochester; 🇺🇸 Rochester, Minnesota, United States