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Mindfulness and Neural Cardiovascular Control in Humans

Primary Purpose

Elevated Blood Pressure

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Stress Management

About this trial

This is an interventional basic science trial for Elevated Blood Pressure

Eligibility Criteria

18 Years - 45 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

Purdue University Northwest

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Mindfulness-Based Stress Reduction

Stress Management Education

Arm Description

Outcomes

Primary Outcome Measures

Sympathetic nerve activity

Direct recordings of muscle sympathetic nerve activity from the peroneal nerve using microneurography.

Secondary Outcome Measures

Arterial stiffness

Carotid-femoral pulse wave velocity using applanation tonometry.

Full Information

NCT ID

NCT03626363

First Posted

August 8, 2018

Last Updated

March 13, 2023

Sponsor

Michigan Technological University

Collaborators

Emory University, Texas Tech University, Purdue University

1. Study Identification

Unique Protocol Identification Number

NCT03626363

Brief Title

Mindfulness and Neural Cardiovascular Control in Humans

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

March 2023

Overall Recruitment Status

Completed

Study Start Date

September 4, 2018 (Actual)

Primary Completion Date

November 23, 2022 (Actual)

Study Completion Date

January 31, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Michigan Technological University

Collaborators

Emory University, Texas Tech University, Purdue University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Elevated Blood Pressure

7. Study Design

Primary Purpose

Basic Science

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

52 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Mindfulness-Based Stress Reduction

Arm Type

Experimental

Arm Title

Stress Management Education

Arm Type

Active Comparator

Intervention Type

Behavioral

Intervention Name(s)

Stress Management

Intervention Description

An eight week stress reduction course.

Primary Outcome Measure Information:

Title

Sympathetic nerve activity

Description

Direct recordings of muscle sympathetic nerve activity from the peroneal nerve using microneurography.

Time Frame

8 weeks

Secondary Outcome Measure Information:

Title

Arterial stiffness

Description

Carotid-femoral pulse wave velocity using applanation tonometry.

Time Frame

8 weeks

Other Pre-specified Outcome Measures:

Title

Nocturnal blood pressure dip

Description

Change in systolic nocturnal blood pressure (will also record diastolic) during sleep when compared to wakefulness.

Time Frame

8 weeks

Title

Cardiovascular reactivity

Description

Blood pressure reactivity (both systolic and diastolic) to laboratory mental stress.

Time Frame

8 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

45 Years

Accepts Healthy Volunteers

Eligibility 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

Facility Information:

Facility Name

Purdue University Northwest

City

Hammond

State/Province

Indiana

ZIP/Postal Code

46323

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

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Mindfulness and Neural Cardiovascular Control in Humans

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