HELP-HY: Health Education and sLeep Program in HYpertension
Primary Purpose
Prehypertension, Hypertension
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Sleep Enhancement
Health Education
Sponsored by
About this trial
This is an interventional treatment trial for Prehypertension
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
- 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
Sites / Locations
- Mayo Clinic in RochesterRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Sleep Enhancement
Health Education
Arm Description
Outcomes
Primary Outcome Measures
change in 48-hour mean arterial pressure
changes in ambulatory measure of blood pressure
Secondary Outcome Measures
changes in 48-hour heart rate
changes in 24-hour heart rate
changes in baroreflex sensitivity
changes in baroreflex sensitivity
changes in endothelial function
changes in endothelial function
changes in renin
changes in renin
changes in angiotensin peptides
changes in angiotensin peptides
changes in aldosterone
changes in aldosterone
changes in insulin sensitivity
changes in insulin sensitivity
changes in cortisol
changes in cortisol
changes in body fat
changes in body fat
changes in catecholamines
changes in catecholamines
Full Information
NCT ID
NCT03255746
First Posted
August 8, 2017
Last Updated
August 2, 2023
Sponsor
Mayo Clinic
Collaborators
National Heart, Lung, and Blood Institute (NHLBI)
1. Study Identification
Unique Protocol Identification Number
NCT03255746
Brief Title
HELP-HY: Health Education and sLeep Program in HYpertension
Official Title
HELP-HY: Health Education and sLeep Program in HYpertension
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 19, 2018 (Actual)
Primary Completion Date
June 30, 2024 (Anticipated)
Study Completion Date
June 30, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mayo Clinic
Collaborators
National Heart, Lung, and Blood Institute (NHLBI)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prehypertension, Hypertension
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
80 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Sleep Enhancement
Arm Type
Experimental
Arm Title
Health Education
Arm Type
Placebo Comparator
Intervention Type
Behavioral
Intervention Name(s)
Sleep Enhancement
Intervention Description
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
Intervention Name(s)
Health Education
Intervention Description
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 Measure Information:
Title
change in 48-hour mean arterial pressure
Description
changes in ambulatory measure of blood pressure
Time Frame
8 weeks
Secondary Outcome Measure Information:
Title
changes in 48-hour heart rate
Description
changes in 24-hour heart rate
Time Frame
8 weeks
Title
changes in baroreflex sensitivity
Description
changes in baroreflex sensitivity
Time Frame
8 weeks
Title
changes in endothelial function
Description
changes in endothelial function
Time Frame
8 weeks
Title
changes in renin
Description
changes in renin
Time Frame
8 weeks
Title
changes in angiotensin peptides
Description
changes in angiotensin peptides
Time Frame
8 weeks
Title
changes in aldosterone
Description
changes in aldosterone
Time Frame
8 weeks
Title
changes in insulin sensitivity
Description
changes in insulin sensitivity
Time Frame
8 weeks
Title
changes in cortisol
Description
changes in cortisol
Time Frame
8 weeks
Title
changes in body fat
Description
changes in body fat
Time Frame
8 weeks
Title
changes in catecholamines
Description
changes in catecholamines
Time Frame
8 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Madeline Reid
Phone
507-255-0007
Email
CPLSLEEPEXT@mayo.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Naima Covassin, PhD
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Virend Somers, MD, PhD
Organizational Affiliation
Mayo Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mayo Clinic in Rochester
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Individual Site Status
Recruiting
12. IPD Sharing Statement
Plan to Share IPD
No
Links:
URL
http://www.mayo.edu/research/clinical-trials
Description
Mayo Clinic Clinical Trials
Learn more about this trial
HELP-HY: Health Education and sLeep Program in HYpertension
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