Autonomic Nervous System Function - Hypertension

NCT05312996 | Suspended

• 1 other identifier: I-0017
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Hypertension

Outcome Measures

Primary Outcomes (2)

• Heart Rate Varability

  Caretaker Heart Rate Variability (HRV) Electrocardiogram (ECG) wrist monitor and chest patch.

  Through study completion, an average of 1 year

• Galvanic Skin Response

  Galvanic Skin Response- measuring autonomic response-via perspiration

  Through study completion, an average of 1 year

Study Arms (2)

Hypertension

EXPERIMENTAL

Hypertension test group.

Other: Heart Rate Variability; Other: Galvanic Skin Response (Biopac)

Active Comparator

OTHER

Non Hypertension compare group.

Other: Heart Rate Variability; Other: Galvanic Skin Response (Biopac)

Interventions

Heart Rate Variability OTHER

Caretaker Heart Rate Variability ECG wrist monitor and chest patch.

Active Comparator; Hypertension

Galvanic Skin Response (Biopac) OTHER

Galvanic Skin Response- measuring autonomic response-via perspiration

Active Comparator; Hypertension

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Life University: lead

Study Sites (1)

Dr. Sid E. Williams Center for Chiropractic Research

Atlanta, Georgia, 30308, United States

Location

MeSH Terms

Conditions

Hypertension

Interventions

Galvanic Skin Response

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Psychological Techniques; Investigative Techniques; Behavioral Disciplines and Activities; Electrophysiological Phenomena; Physiological Phenomena; Skin Physiological Phenomena; Integumentary System Physiological Phenomena

Study Officials

• Stephanie Sullivan, DC, PhD

  Life Univeristy

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 2, 2022
• First Posted: April 6, 2022
• Study Start: October 1, 2021
• Primary Completion: October 26, 2023
• Study Completion: October 26, 2023
• Last Updated: May 3, 2023

Record last verified: 2023-05

Locations

US (1)