HELP-HY: Health Education and sLeep Program in HYpertension

Overview

About this study

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).

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

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

Eligibility last updated6/7/22. Questions regarding updates should be directed to the study team contact.

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location	Status	Contact
Rochester, Minn. Mayo Clinic principal investigator Virend Somers, M.D., Ph.D.	Open for enrollment	Contact information: CPL Hypertension Sleep Study CPLSleepExt@mayo.edu

Mayo Clinic Location

Status

Contact

Rochester, Minn.

Mayo Clinic principal investigator

Virend Somers, M.D., Ph.D.

Open for enrollment

Contact information:

CPL Hypertension Sleep Study

CPLSleepExt@mayo.edu

More information

Publications

Publications are currently not available

Clinical Trials