HELP-HY: Health Education and sLeep Program in HYpertension

NCT03255746 | Active Not Recruiting

• 2 other identifiers: 17-004044R01HL134808
• Study Type: interventional
• Target: 110
• Locations: 1 country
• Sites: 1

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).

Conditions

Prehypertension; Hypertension

Outcome Measures

Primary Outcomes (1)

• change in 48-hour mean arterial pressure

  changes in ambulatory measure of blood pressure

  8 weeks

Secondary Outcomes (10)

• changes in 48-hour heart rate

  8 weeks

• changes in baroreflex sensitivity

  8 weeks

• changes in endothelial function

  8 weeks

• changes in renin

  8 weeks

• changes in angiotensin peptides

  8 weeks

Study Arms (2)

Sleep Enhancement

EXPERIMENTAL

Behavioral: Sleep Enhancement

Health Education

PLACEBO COMPARATOR

Behavioral: Health Education

Interventions

Sleep Enhancement BEHAVIORAL

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.

Sleep Enhancement

Health Education BEHAVIORAL

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.

Health Education

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Mayo Clinic: lead
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

Study Sites (1)

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Location

MeSH Terms

Conditions

Prehypertension; Hypertension

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Study Officials

• Virend Somers, MD, PhD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Medicine

Study Record Dates

• First Submitted: August 8, 2017
• First Posted: August 21, 2017
• Study Start: April 19, 2018
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 1, 2026
• Last Updated: January 12, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)