Mindfulness and Neural Cardiovascular Control in Humans

Elevated Blood Pressure Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03626363
• Other study ID #: M1690
• Status: Completed
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Elevated Blood Pressure
• Hypertension

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