Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Mindfulness and Neural Cardiovascular Control in Humans

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03626363
Recruitment Status : Recruiting
First Posted : August 13, 2018
Last Update Posted : March 13, 2020
Sponsor:
Collaborators:
Emory University
Texas Tech University
Information provided by (Responsible Party):
Michigan Technological University

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Elevated Blood Pressure Behavioral: Stress Management Not Applicable

Detailed Description:
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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Randomized, Active-Control Study to Determine the Effect of Mindfulness-Based Stress Reduction on Sympathetic Activity and Arterial Stiffness
Actual Study Start Date : September 4, 2018
Estimated Primary Completion Date : July 31, 2020
Estimated Study Completion Date : January 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Mindfulness-Based Stress Reduction Behavioral: Stress Management
An eight week stress reduction course.

Active Comparator: Stress Management Education Behavioral: Stress Management
An eight week stress reduction course.




Primary Outcome Measures :
  1. Sympathetic nerve activity [ Time Frame: 8 weeks ]
    Direct recordings of muscle sympathetic nerve activity from the peroneal nerve using microneurography.


Secondary Outcome Measures :
  1. Arterial stiffness [ Time Frame: 8 weeks ]
    Carotid-femoral pulse wave velocity using applanation tonometry.


Other Outcome Measures:
  1. Nocturnal blood pressure dip [ Time Frame: 8 weeks ]
    Change in systolic nocturnal blood pressure (will also record diastolic) during sleep when compared to wakefulness.

  2. Cardiovascular reactivity [ Time Frame: 8 weeks ]
    Blood pressure reactivity (both systolic and diastolic) to laboratory mental stress.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03626363


Contacts
Layout table for location contacts
Contact: John Durocher, PhD 906-487-1659 jjduroch@mtu.edu

Locations
Layout table for location information
United States, Michigan
Michigan Technological University Recruiting
Houghton, Michigan, United States, 49931
Contact: John Durocher, PhD    906-487-1659    jjduroch@mtu.edu   
Principal Investigator: John J Durocher, PhD         
Sponsors and Collaborators
Michigan Technological University
Emory University
Texas Tech University
Layout table for additonal information
Responsible Party: Michigan Technological University
ClinicalTrials.gov Identifier: NCT03626363    
Other Study ID Numbers: M1690
First Posted: August 13, 2018    Key Record Dates
Last Update Posted: March 13, 2020
Last Verified: March 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Hypertension
Vascular Diseases
Cardiovascular Diseases