HELP-HY: Health Education and sLeep Program in HYpertension

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).

Study Overview

• Status: Recruiting
• Conditions: Hypertension; Prehypertension
• Intervention / Treatment: Behavioral: Sleep Enhancement; Behavioral: Health Education

• Study Type: Interventional
• Enrollment (Estimated): 80
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Madeline Reid; Phone Number: 507-255-0007; Email: CPLSLEEPEXT@mayo.edu
• Study Contact Backup: Name: Naima Covassin, PhD

Study Locations

• United States
  • Minnesota
    • Rochester, Minnesota, United States, 55905
      • Recruiting
      • Mayo Clinic in Rochester

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Sleep Enhancement	Behavioral: 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.
Placebo Comparator: Health Education	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
change in 48-hour mean arterial pressure	changes in ambulatory measure of blood pressure	8 weeks

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Mayo Clinic
• Collaborators: National Heart, Lung, and Blood Institute (NHLBI)
• Investigators: Principal Investigator: Virend Somers, MD, PhD, Mayo Clinic

Publications and helpful links

Helpful Links

• Mayo Clinic Clinical Trials

Study record dates

Study Major Dates

• Study Start (Actual): April 19, 2018
• Primary Completion (Estimated): June 30, 2024
• Study Completion (Estimated): June 30, 2024

Study Registration Dates

• First Submitted: August 8, 2017
• First Submitted That Met QC Criteria: August 16, 2017
• First Posted (Actual): August 21, 2017

Study Record Updates

• Last Update Posted (Actual): August 3, 2023
• Last Update Submitted That Met QC Criteria: August 2, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Hypertension; Prehypertension
• Other Study ID Numbers: 17-004044; R01HL134808 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No