Autonomic Nervous System Function - Hypertension

NCT ID: NCT05312996

Last Updated: 2023-05-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

SUSPENDED

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-10-01

Study Completion Date

2023-10-26

Brief Summary

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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.

Detailed Description

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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

Conditions

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Hypertension

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Hypertension

Hypertension test group.

Group Type EXPERIMENTAL

Heart Rate Variability

Intervention Type OTHER

Caretaker Heart Rate Variability ECG wrist monitor and chest patch.

Galvanic Skin Response (Biopac)

Intervention Type OTHER

Galvanic Skin Response- measuring autonomic response-via perspiration

Active Comparator

Non Hypertension compare group.

Group Type OTHER

Heart Rate Variability

Intervention Type OTHER

Caretaker Heart Rate Variability ECG wrist monitor and chest patch.

Galvanic Skin Response (Biopac)

Intervention Type OTHER

Galvanic Skin Response- measuring autonomic response-via perspiration

Interventions

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Heart Rate Variability

Caretaker Heart Rate Variability ECG wrist monitor and chest patch.

Intervention Type OTHER

Galvanic Skin Response (Biopac)

Galvanic Skin Response- measuring autonomic response-via perspiration

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Life University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Stephanie Sullivan, DC, PhD

Role: STUDY_DIRECTOR

Life Univeristy

Locations

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Dr. Sid E. Williams Center for Chiropractic Research

Atlanta, Georgia, United States

Site Status

Countries

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United States

Other Identifiers

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I-0017

Identifier Type: -

Identifier Source: org_study_id

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