HELP-HY: Health Education and sLeep Program in HYpertension

Hypertension Clinical Trial

Official title:

HELP-HY: Health Education and sLeep Program in HYpertension

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03255746
• Other study ID #: 17-004044
• Secondary ID: R01HL134808
• Status: Recruiting
• Phase: N/A
• Start date: April 19, 2018
• Est. completion date: June 30, 2024

Study information

• Verified date: August 2023
• Source: Mayo Clinic
• Contact: Madeline Reid
• Phone: 507-255-0007
• Email: CPLSLEEPEXT[@]mayo.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: June 30, 2024
• Est. primary completion date: June 30, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Hypertension
• Prehypertension

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	Mayo Clinic in Rochester	Rochester	Minnesota

Sponsors (2)

Lead Sponsor	Collaborator
Mayo Clinic	National Heart, Lung, and Blood Institute (NHLBI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	change in 48-hour mean arterial pressure	changes in ambulatory measure of blood pressure	8 weeks
Secondary	changes in 48-hour heart rate	changes in 24-hour heart rate	8 weeks
Secondary	changes in baroreflex sensitivity	changes in baroreflex sensitivity	8 weeks
Secondary	changes in endothelial function	changes in endothelial function	8 weeks
Secondary	changes in renin	changes in renin	8 weeks
Secondary	changes in angiotensin peptides	changes in angiotensin peptides	8 weeks
Secondary	changes in aldosterone	changes in aldosterone	8 weeks
Secondary	changes in insulin sensitivity	changes in insulin sensitivity	8 weeks
Secondary	changes in cortisol	changes in cortisol	8 weeks
Secondary	changes in body fat	changes in body fat	8 weeks
Secondary	changes in catecholamines	changes in catecholamines	8 weeks

External Links

•   Mayo Clinic Clinical Trials