Skip to main content
OpenTrials
Completed

NCT Number: NCT03626363

Mindfulness and Neural Cardiovascular Control in Humans

This study evaluates the impact of mindfulness-based stress reduction (MBSR) on sympathetic nerve activity and arterial stiffness. The investigator's central hypothesis is that MBSR will reduce sympathetic activity and arterial stiffness.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Elevated Blood Pressure Cardiovascular Diseases Hypertension Vascular Diseases

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Purdue University Northwest

Hammond, Indiana, 46323, United States

About this study

This study will recruit male and female subjects with elevated blood pressure who will participate in a randomized, active control study to examine the impact of mindfulness-based stress reduction (MBSR) on blood pressure, muscle sympathetic nerve activity and arterial stiffness. The study will utilize established techniques for assessing blood pressure patterns (24-hour ambulatory monitoring), peripheral sympathetic activity (microneurography) and vascular stiffness (applanation tonometry) in humans. This study includes a stress management education class for the active control.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Seated systolic blood pressure >119 mmHg and/or diastolic blood pressure >79 mmHg
  • Body mass index <30 kg/m2

Exclusion criteria

  • Smokers
  • Diabetes
  • Pregnant women
  • History of autonomic dysfunction
  • Cardiovascular medication

Treatment and study plan

Stress Management

Behavioral

An eight week stress reduction course.

Primary outcomes

  1. Muscle Sympathetic Nerve Activity

    Time frame: Data reported is the change in the mean value from before to after the 8 week intervention (i.e. pre to post).

    Direct recordings of muscle sympathetic nerve activity from the peroneal nerve using microneurography. Sympathetic bursts that were at least three times higher than baseline noise were evaluated by a trained investigator and quantified as bursts per minute. The investigator was blinded to the condition and whether the data was pre or post until after all data was collected and analyzed.

Secondary outcomes

  1. Arterial Stiffness

    Time frame: Data reported is the change in the mean value from before to after the 8 week intervention (i.e. pre to post).

    Carotid-femoral pulse wave velocity using applanation tonometry. A SphygmoCor system was used to gait pulse waves from a tonometer to the R-wave of a 3-lead ECG and carotid to femoral pulse wave velocity was evaluated in meters per second. A higher value indicates more arterial stiffness in the aorta, and a lower value indicates less stiffness in the aorta.

Other outcomes

  1. Nocturnal Blood Pressure Dip

    Time frame: Data reported is the change in the mean value from before to after the 8 week intervention (i.e. pre to post).

    Change in systolic nocturnal blood pressure during sleep when compared to wakefulness. We used ambulatory blood pressure monitors set to record blood pressures every 30 minutes while the participant was sleeping and every 20 minutes while they were awake for a 24-hour period once before and once after the 8-week intervention. Values reported are the percentage of systolic arterial pressure dipping during sleep compared to wakefulness before vs. after the 8 week intervention.

Sponsors and collaborators

Lead sponsor

Michigan Technological University

Other

Collaborators

  • Emory University
  • National Heart, Lung, and Blood Institute (NHLBI)
  • Purdue University
  • Texas Tech University

Registry information

Official study title

Randomized, Active-Control Study to Determine the Effect of Mindfulness-Based Stress Reduction on Sympathetic Activity and Arterial Stiffness

Important dates

Study start
2018
Primary completion
2022
Study completion
2023
First posted
Aug 13, 2018
Registry last updated
Nov 8, 2024

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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.