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HELP-HY: Health Education and sLeep Program in HYpertension

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ClinicalTrials.gov Identifier: NCT03255746
Recruitment Status : Recruiting
First Posted : August 21, 2017
Last Update Posted : October 15, 2021
Sponsor:
Collaborator:
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
Virend Somers, MD, PhD, Mayo Clinic

Tracking Information
First Submitted Date  ICMJE August 8, 2017
First Posted Date  ICMJE August 21, 2017
Last Update Posted Date October 15, 2021
Actual Study Start Date  ICMJE April 19, 2018
Estimated Primary Completion Date June 30, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 19, 2018)
change in 48-hour mean arterial pressure [ Time Frame: 8 weeks ]
changes in ambulatory measure of blood pressure
Original Primary Outcome Measures  ICMJE
 (submitted: August 16, 2017)
change in 24-hour mean arterial pressure [ Time Frame: 8 weeks ]
changes in ambulatory measure of blood pressure
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 19, 2018)
  • changes in 48-hour heart rate [ Time Frame: 8 weeks ]
    changes in 24-hour heart rate
  • changes in baroreflex sensitivity [ Time Frame: 8 weeks ]
    changes in baroreflex sensitivity
  • changes in endothelial function [ Time Frame: 8 weeks ]
    changes in endothelial function
  • changes in renin [ Time Frame: 8 weeks ]
    changes in renin
  • changes in angiotensin peptides [ Time Frame: 8 weeks ]
    changes in angiotensin peptides
  • changes in aldosterone [ Time Frame: 8 weeks ]
    changes in aldosterone
  • changes in insulin sensitivity [ Time Frame: 8 weeks ]
    changes in insulin sensitivity
  • changes in cortisol [ Time Frame: 8 weeks ]
    changes in cortisol
  • changes in body fat [ Time Frame: 8 weeks ]
    changes in body fat
  • changes in catecholamines [ Time Frame: 8 weeks ]
    changes in catecholamines
Original Secondary Outcome Measures  ICMJE
 (submitted: August 16, 2017)
  • changes in 24-hour heart rate [ Time Frame: 8 weeks ]
    changes in 24-hour heart rate
  • changes in baroreflex sensitivity [ Time Frame: 8 weeks ]
    changes in baroreflex sensitivity
  • changes in muscle sympathetic nerve activity [ Time Frame: 8 weeks ]
    changes in muscle sympathetic nerve activity
  • changes in endothelial function [ Time Frame: 8 weeks ]
    changes in endothelial function
  • changes in renin [ Time Frame: 8 weeks ]
    changes in renin
  • changes in angiotensin peptides [ Time Frame: 8 weeks ]
    changes in angiotensin peptides
  • changes in aldosterone [ Time Frame: 8 weeks ]
    changes in aldosterone
  • changes in insulin sensitivity [ Time Frame: 8 weeks ]
    changes in insulin sensitivity
  • changes in cortisol [ Time Frame: 8 weeks ]
    changes in cortisol
  • changes in body fat [ Time Frame: 8 weeks ]
    changes in body fat
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE HELP-HY: Health Education and sLeep Program in HYpertension
Official Title  ICMJE HELP-HY: Health Education and sLeep Program in HYpertension
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 Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Prehypertension
  • Hypertension
Intervention  ICMJE
  • 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.
  • 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.
Study Arms  ICMJE
  • Experimental: Sleep Enhancement
    Intervention: Behavioral: Sleep Enhancement
  • Placebo Comparator: Health Education
    Intervention: Behavioral: Health Education
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: August 16, 2017)
94
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE June 30, 2022
Estimated Primary Completion Date June 30, 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
  • Presence of prehypertension, Stage 1 hypertension, 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 and/or excessive caffeine intake
  • Currently on a diet and/or actively trying to lose weight
  • History of drowsing driving
  • Severe daytime sleepiness
  • 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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Carrie Witter (507) 255-0492 CPLSLEEPEXT@mayo.edu
Contact: Naima Covassin, PhD
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03255746
Other Study ID Numbers  ICMJE 17-004044
R01HL134808 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Virend Somers, MD, PhD, Mayo Clinic
Study Sponsor  ICMJE Mayo Clinic
Collaborators  ICMJE National Heart, Lung, and Blood Institute (NHLBI)
Investigators  ICMJE
Principal Investigator: Virend Somers, MD, PhD Mayo Clinic
PRS Account Mayo Clinic
Verification Date October 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP