HELP-HY: Health Education and sLeep Program in HYpertension

Overview

Información sobre este estudio

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).

Elegibilidad para la participación

Los requisitos de elegibilidad de los participantes incluyen la edad, el sexo, el tipo y el estadio de la enfermedad, y los problemas de salud o tratamientos previos. Las pautas difieren de un estudio a otro e identifican quiénes pueden o no pueden participar. No hay garantía de que cada persona elegible que desee participar en un ensayo se inscribirá. Comunícate con el equipo del estudio para analizar la elegibilidad del estudio y la posible participación.

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.

 

Sedes participantes de Mayo Clinic

Los estatus de los estudios cambian con frecuencia. Comunícate con el equipo del estudio para obtener la información más actualizada acerca de la posibilidad de participar.

Sede de Mayo Clinic Estatus Contacto

Rochester, Minn.

Investigador principal de Mayo Clinic

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

Abierto para la inscripción

Contact information:

CPL Hypertension Sleep Study

CPLSleepExt@mayo.edu

More information

Publicaciones

Publications are currently not available