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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 : February 11, 2019
Sponsor:
Collaborator:
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
Virend Somers, 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).


Condition or disease Intervention/treatment Phase
Prehypertension Hypertension Behavioral: Sleep Enhancement Behavioral: Health Education Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 94 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: HELP-HY: Health Education and sLeep Program in HYpertension
Actual Study Start Date : April 19, 2018
Estimated Primary Completion Date : June 30, 2022
Estimated Study Completion Date : June 30, 2022

Resource links provided by the National Library of Medicine


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.




Primary Outcome Measures :
  1. change in 48-hour mean arterial pressure [ Time Frame: 8 weeks ]
    changes in ambulatory measure of blood pressure


Secondary Outcome Measures :
  1. changes in 48-hour heart rate [ Time Frame: 8 weeks ]
    changes in 24-hour heart rate

  2. changes in baroreflex sensitivity [ Time Frame: 8 weeks ]
    changes in baroreflex sensitivity

  3. changes in endothelial function [ Time Frame: 8 weeks ]
    changes in endothelial function

  4. changes in renin [ Time Frame: 8 weeks ]
    changes in renin

  5. changes in angiotensin peptides [ Time Frame: 8 weeks ]
    changes in angiotensin peptides

  6. changes in aldosterone [ Time Frame: 8 weeks ]
    changes in aldosterone

  7. changes in insulin sensitivity [ Time Frame: 8 weeks ]
    changes in insulin sensitivity

  8. changes in cortisol [ Time Frame: 8 weeks ]
    changes in cortisol

  9. changes in body fat [ Time Frame: 8 weeks ]
    changes in body fat

  10. changes in catecholamines [ Time Frame: 8 weeks ]
    changes in catecholamines



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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 ≤6.5 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 >6.5 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03255746


Contacts
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Contact: Carrie Witter (507) 255-0492 CPLSLEEPEXT@mayo.edu
Contact: Naima Covassin, PhD

Locations
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United States, Minnesota
Mayo Clinic in Rochester Recruiting
Rochester, Minnesota, United States, 55905
Sponsors and Collaborators
Mayo Clinic
National Heart, Lung, and Blood Institute (NHLBI)
Investigators
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Principal Investigator: Virend Somers, MD, PhD Mayo Clinic

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Responsible Party: Virend Somers, Professor of Medicine, Mayo Clinic
ClinicalTrials.gov Identifier: NCT03255746     History of Changes
Other Study ID Numbers: 17-004044
R01HL134808 ( U.S. NIH Grant/Contract )
First Posted: August 21, 2017    Key Record Dates
Last Update Posted: February 11, 2019
Last Verified: February 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Hypertension
Prehypertension
Vascular Diseases
Cardiovascular Diseases