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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03626363
Other study ID # M1690
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date September 4, 2018
Est. completion date January 31, 2023

Study information

Verified date March 2023
Source Michigan Technological University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 52
Est. completion date January 31, 2023
Est. primary completion date November 23, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 45 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Stress Management
An eight week stress reduction course.

Locations

Country Name City State
United States Purdue University Northwest Hammond Indiana

Sponsors (4)

Lead Sponsor Collaborator
Michigan Technological University Emory University, Purdue University, Texas Tech University

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Other Nocturnal blood pressure dip Change in systolic nocturnal blood pressure (will also record diastolic) during sleep when compared to wakefulness. 8 weeks
Other Cardiovascular reactivity Blood pressure reactivity (both systolic and diastolic) to laboratory mental stress. 8 weeks
Primary Sympathetic nerve activity Direct recordings of muscle sympathetic nerve activity from the peroneal nerve using microneurography. 8 weeks
Secondary Arterial stiffness Carotid-femoral pulse wave velocity using applanation tonometry. 8 weeks
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