Elevated Blood PressureNCT03626363

Mindfulness and Neural Cardiovascular Control in Humans

A study testing Stress Management in people with Elevated Blood Pressure, run by Michigan Technological University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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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. Read more about this study

Who is it for?: Ages 18 to 45 yearsHealthy volunteers can take part
Conditions the study is for: Elevated Blood Pressure
What is being tested?: Stress Management
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 52 participants
Where: 1 siteUnited States
Study dates: 4 Sep 2018to 31 Jan 2023
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 45 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

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

Who cannot join

Smokers
Diabetes
Pregnant women
History of autonomic dysfunction
Cardiovascular medication

Trial locations and contacts

1 site in 1 country.

United States1 site

Purdue University Northwest
Hammond, Indiana, 46323

Other trials in United States

About this study

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

Read the 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.

Conditions: Elevated Blood Pressure
Being tested: Stress Management
Medical subject headings: Hypertension

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Stress ManagementBehavioural
An eight week stress reduction course.

Study groups in NCT03626363
Study group	Role	What they receive
Mindfulness-Based Stress Reduction	Experimental	An 8-week program specifically designed to improve mindfulness and to reduce stress. Receives: Behavioral: Stress Management
Stress Management Education	Active comparator	An 8-week program specifically designed to provide education about stress responses in humans, and as an active control for Mindfulness-Based Stress Reduction studies. Receives: Behavioral: Stress Management

What is being measured

The primary outcome is the main question the study is designed to answer.

Muscle Sympathetic Nerve Activity
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.
Measured: Data reported is the change in the mean value from before to after the 8 week intervention (i.e. pre to post).

Secondary outcomes (1)

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

4 Sep 201831 Jan 2023

First posted13 Aug 2018
Study start4 Sep 2018
Primary completion23 Nov 2022
Study completion31 Jan 2023

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Elevated Blood PressureStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Basic science
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 52 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03626363
Sponsor's protocol ID: M1690
Other IDs: 1R15HL140596-01
Status last verified: Nov 2024
First submitted: 8 Aug 2018
Last updated: 8 Nov 2024
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 8 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Randomized, Active-Control Study to Determine the Effect of Mindfulness-Based Stress Reduction on Sympathetic Activity and Arterial Stiffness
ClinicalTrials.gov ID: NCT03626363
Acronym / sponsor ID: M1690
Conditions: Elevated Blood Pressure
Study type: Interventional
Recruitment status: Completed
Enrolment: 52 participants (actual)
Lead sponsor: Michigan Technological UniversityUniversity, hospital or other
Collaborators: Emory University, Texas Tech University, Purdue University, National Heart, Lung, and Blood Institute (NHLBI)
Study start: 4 Sep 2018 (actual)
Primary completion: 23 Nov 2022 (actual)
Study completion: 31 Jan 2023 (actual)
First posted: 13 Aug 2018 (actual)
Results: Posted 8 Nov 2024

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Basic science
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Mindfulness-Based Stress Reduction	Experimental	Behavioral: Stress ManagementAn 8-week program specifically designed to improve mindfulness and to reduce stress.
Stress Management Education	Active comparator	Behavioral: Stress ManagementAn 8-week program specifically designed to provide education about stress responses in humans, and as an active control for Mindfulness-Based Stress Reduction studies.

Who may qualify

Ages: 18 to 45 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (2 listed)

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

Key exclusion criteria (5 listed)

Smokers
Diabetes
Pregnant women
History of autonomic dysfunction
Cardiovascular medication

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Stress ManagementAn eight week stress reduction course.	Behavioural	Mindfulness-Based Stress Reduction, Stress Management Education

Primary outcome

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.

1 secondary outcome

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).

Results and safety

Results posted to the registry on 8 Nov 2024, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Mindfulness-Based Stress Reduction	27	18
Stress Management Education	25	18

Primary outcome: 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).. Mean (Standard Error). Unit: bursts per minute

Measure	Mindfulness-Based Stress Reduction n = 5	Stress Management Education n = 5
Value	-2 (2)	-1 (2)

Mindfulness-Based Stress Reduction vs Stress Management Education: Mean Difference (Net): -2, p = 0.51, ANOVA

Population analysed: We had 21 participants in the spring of 2020 with excellent success on baseline nerve recordings, but with COVID-19 restrictions we were not allowed to bring any participants into the laboratory for post testing. This resulted in the limited sample size of 5 participants in each arm with excellent muscle sympathetic nerve recordings both before and after the 8-week interventions.

1 secondary outcome is reported in the full results.

Adverse events

Time frame: Participants were randomized into an 8-week mindfulness-based stress reduction OR 8-week stress management education intervention. We pre-tested participants within a week of starting the interventions, and then post-tested them within a week of completing the interventions. Thus, each participant was monitored for a period of 10 weeks.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Mindfulness-Based Stress Reduction	0 of 27 (0%)	0 of 27 (0%)	0 of 27
Stress Management Education	0 of 25 (0%)	0 of 25 (0%)	0 of 25

Limitations and caveats (from the sponsor): In spring 2020 we had 21 participants enrolled, and we shifted the MBSR and SME courses to Zoom for the final 4 weeks of each intervention. We were able to send out questionnaires to participants for post testing, but we were not allowed to post-test anyone in the lab for our three specific aims related to blood pressure dipping, MSNA, or arterial stiffness due to COVID-19 restrictions. The original PI moved to a new position in the summer of 2020 which provided some additional complications.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 8 Nov 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

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Chronic Kidney Disease, Hypertension (HTN)
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

John Durocher, PhD principal investigator

Purdue University Northwest Biological Sciences

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Stress Management in people with Elevated Blood Pressure, run by Michigan Technological University at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 8 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 8 Nov 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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).). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03626363.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Nov 2024.