Autonomic Nervous System Function - Hypertension

May 2, 2023 updated by: Life University

Perceived Stress and Patterns of Autonomic Function: a Protocol Development Study

The Life University Center for Chiropractic Research is conducting a research study to better understand the physiological differences, in terms of Autonomic nervous system function, between individuals with Hypertension and control individuals with out hypertension. Data will be gathered using Heart Rate Variability (HRV), and Galvanic Skin Response (GSR). A series of tests will be conducted to elicit Autonomic Nervous system responses. These tests include Cold Face Test (mammalian dive reflex), Cold Pressor test, Sit to stand, and the Valsalva maneuver.

Study Overview

Status

Suspended

Conditions

Intervention / Treatment

Detailed Description

The objective of the study is to ascertain the level of autonomic health in persons with hypertension versus a healthy population. Further, via the implemented protocol, the study will attempt to develop a sequence of autonomic nervous system tests to be used in future studies and clinical settings

Study Type

Interventional

Enrollment (Anticipated)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Georgia
      • Atlanta, Georgia, United States, 30308
        • Dr. Sid E. Williams Center for Chiropractic Research

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

Participants will be included in the hypertension group if they present with the following:

  • Hypertension, defined as:
  • Self-reported or previously diagnosed with elevated resting state blood pressure (120-129 systolic and less than 80 mmHg diastolic) or stage 1 hypertension with a blood pressure of Systolic between 130- and 139-mm Hg with a diastolic of 80-89 mmHg.
  • Or medically diagnosed and managed stage 2 hypertension with blood pressure of Systolic between 140- and 159-mm Hg or diastolic 90 and 99 mm
  • between the ages of 18-65
  • Able to wear a monitor on their right wrist.
  • Able to wear a pulse oximeter on their left hand.

Participants will be included in the healthy group if they present with the following:

  • between the ages of 18-65
  • Able to wear a monitor on their right wrist.
  • Able to wear a pulse oximeter on their left hand.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Hypertension
Hypertension test group.
Other: Heart Rate Variability
Caretaker Heart Rate Variability ECG wrist monitor and chest patch.
Other: Galvanic Skin Response (Biopac)
Galvanic Skin Response- measuring autonomic response-via perspiration
Other: Active Comparator
Non Hypertension compare group.
Other: Heart Rate Variability
Caretaker Heart Rate Variability ECG wrist monitor and chest patch.
Other: Galvanic Skin Response (Biopac)
Galvanic Skin Response- measuring autonomic response-via perspiration

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Heart Rate Varability
Time Frame: Through study completion, an average of 1 year
Caretaker Heart Rate Variability (HRV) Electrocardiogram (ECG) wrist monitor and chest patch.
Through study completion, an average of 1 year
Galvanic Skin Response
Time Frame: Through study completion, an average of 1 year
Galvanic Skin Response- measuring autonomic response-via perspiration
Through study completion, an average of 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Life University

Investigators

  • Study Director: Stephanie Sullivan, DC, PhD, Life Univeristy

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2021

Primary Completion (Anticipated)

October 26, 2023

Study Completion (Anticipated)

October 26, 2023

Study Registration Dates

First Submitted

March 2, 2022

First Submitted That Met QC Criteria

March 28, 2022

First Posted (Actual)

April 6, 2022

Study Record Updates

Last Update Posted (Actual)

May 3, 2023

Last Update Submitted That Met QC Criteria

May 2, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • I-0017

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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