Autonomic Nervous System Function - Hypertension

Not Applicable

Suspended

• Conditions: Hypertension
• Interventions: Other: Heart Rate Variability; Other: Galvanic Skin Response (Biopac)

• Registration Number: NCT05312996
• Lead Sponsor: Life University

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.

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 Timeline

• Study Start: 2021-10-01
• Study First Submitted: 2022-03-02
• Study First Submitted QC: 2022-03-28
• Study First Posted: 2022-04-06
• Status Verified: 2023-05
• Last Update Submitted: 2023-05-02
• Last Update Posted: 2023-05-03
• Primary Completion: 2023-10-26
• Study Completion: 2023-10-26

Recruitment & Eligibility

• Status: SUSPENDED
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Hypertension	Galvanic Skin Response (Biopac)	Hypertension test group.
Active Comparator	Galvanic Skin Response (Biopac)	Non Hypertension compare group.
Hypertension	Heart Rate Variability	Hypertension test group.
Active Comparator	Heart Rate Variability	Non Hypertension compare group.

Primary Outcome Measures

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

Trial Locations

Locations (1)

Dr. Sid E. Williams Center for Chiropractic Research; 🇺🇸 Atlanta, Georgia, United States