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NCT Number: NCT03043963

Mechanisms Underlying the Blood Pressure Lowering Effect of Sleep

The main purpose of this study is to learn about the influence of two different behavioral interventions (lasting 8 weeks) involving sleep for lowering blood pressure, and to study the mechanisms involved. There is research evidence that healthy sleep promotes heart-health and may decrease blood pressure, and that sensitivity to insufficient or disrupted sleep may be influenced by sex. This research will compare two interventions that are each designed to improve sleep health, and will investigate sex differences in response. The project includes 3 in-hospital stays with biological measurements to evaluate the underlying mechanisms associated with the effectiveness of two different blood pressure lowering behavioral interventions.

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Key information

Conditions

Hypertension Cardiovascular Diseases Vascular Diseases

Age range

25 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

About this study

The study involves home-based sleep-wake data collection before and during behavioral intervention, and 3 overnight stays in the hospital. For each hospital stay participants will be asked to arrive in the afternoon, and stay until the next evening. They will be provided dinner on the first day and breakfast, lunch and dinner on the second day. If they are taking any blood pressure medication they will continue to take it through the study. During the in-hospital stays, blood pressure will be measured continuously using two small finger cuffs. In order to monitor and record brain waves to determine sleep and wakefulness, small gold-coated disks called electrodes will be placed on the head and body. Heart rate, blood pressure and brain activity will be recorded for a little over 24 hours on each in-hospital stay. Before as well as during the in-hospital stays questions will be asked about sleep times, subjective sleepiness and other indices relating to well-being.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • pre-hypertension or stage one hypertension (BP ≥120/80 and <160/100).
  • usual sleep period occurs at night

Exclusion criteria

  • significant active or uncontrolled sleep disorders
  • shiftwork
  • current pregnancy
  • diabetic patients who are insulin dependent (or have HbA1c>9.0%)
  • current use of hypnotics or clonidine
  • renal/electrolyte disorders and any other condition that the study screening physician considers would significantly impede participation in the study

Treatment and study plan

Sleep Extension

Behavioral

Lengthen the duration of sleep time.

Sleep timing

Behavioral

Regularize the timing of the sleep period.

Primary outcomes

  1. Reduction in 24 hour blood pressure

    Time frame: The primary outcome measure will be measured during 3 hospital visit periods of approximately 28 hours each. The primary outcome will be evaluated based on an 8 week behavioral intervention.

    24h blood pressure (daily averaged).

Secondary outcomes

  1. Lowering of sleep period blood pressure

    Time frame: he primary outcome measure will be measured during 3 hospital visit periods ofThe secondary outcome will be evaluated based on an 8 week behavioral intervention.

    Blood pressure during day wake period minus blood pressure at night during sleep period

Sponsors and collaborators

Lead sponsor

Beth Israel Deaconess Medical Center

Other

Registry information

Official study title

Mechanisms Underlying the Blood Pressure Lowering Effect of Sleep Extension

Important dates

Study start
2017
Primary completion
2021
Study completion
2022
First posted
Feb 6, 2017
Registry last updated
Feb 21, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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