Autonomic Nervous System Function - Hypertension

Hypertension Clinical Trial

Official title:

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

Clinical Trial Details — Status: Suspended

Administrative data

• NCT number: NCT05312996
• Other study ID #: I-0017
• Status: Suspended
• Phase: N/A
• Start date: October 1, 2021
• Est. completion date: October 26, 2023

Study information

• Verified date: May 2023
• Source: Life University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Suspended
• Enrollment: 30
• Est. completion date: October 26, 2023
• Est. primary completion date: October 26, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Hypertension

Intervention

Other:
• Heart Rate Variability
Caretaker Heart Rate Variability ECG wrist monitor and chest patch.
• Galvanic Skin Response (Biopac)
Galvanic Skin Response- measuring autonomic response-via perspiration

Locations

Country	Name	City	State
United States	Dr. Sid E. Williams Center for Chiropractic Research	Atlanta	Georgia

Sponsors (1)

Lead Sponsor	Collaborator
Life University

Country where clinical trial is conducted

United States, 

Outcome

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