HELP-HY: Health Education and sLeep Program in HYpertension

NCT ID: NCT03255746

Last Updated: 2026-01-12

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 110 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-04-19
• Study Completion Date: 2026-06-30

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Sleep Enhancement

Group Type: EXPERIMENTAL

Sleep Enhancement

Intervention Type: 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.

Health Education

Group Type: PLACEBO_COMPARATOR

Health Education

Intervention Type: 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.

Interventions

Sleep Enhancement

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.

Intervention Type: BEHAVIORAL

Health Education

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.

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National Heart, Lung, and Blood Institute (NHLBI)

NIH

Sponsor Role: collaborator

Mayo Clinic

OTHER

Sponsor Role: lead

Responsible Party

Virend Somers, MD, PhD

Professor of Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Virend Somers, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Mayo Clinic

Locations

Mayo Clinic in Rochester

Rochester, Minnesota, United States

Countries

United States

Other Identifiers

R01HL134808

Identifier Type: NIH

Identifier Source: secondary_id

View Link

17-004044

Identifier Type: -

Identifier Source: org_study_id