HypertensionNCT05312996
Autonomic Nervous System Function - Hypertension
A study testing Heart Rate Variability and Galvanic Skin Response (Biopac) in people with Hypertension, run by Life University at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Hypertension
- What is being tested?
- Heart Rate Variability and Galvanic Skin Response (Biopac)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Oct 2021to 26 Oct 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Dr. Sid E. Williams Center for Chiropractic Research
Atlanta, Georgia, 30308
About this study
Official title: 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.
Read the 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
- Conditions
- Hypertension
- Being tested
- Heart Rate Variability, Galvanic Skin Response (Biopac)
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Heart Rate VariabilityOther
Caretaker Heart Rate Variability ECG wrist monitor and chest patch.
Galvanic Skin Response (Biopac)Other
Galvanic Skin Response- measuring autonomic response-via perspiration
| Study group | Role | What they receive |
|---|---|---|
| Hypertension | Experimental | Hypertension test group. Receives: Other: Heart Rate Variability; Other: Galvanic Skin Response (Biopac) |
| Active Comparator | Other | Non Hypertension compare group. Receives: Other: Heart Rate Variability; Other: Galvanic Skin Response (Biopac) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Heart Rate Varability
Caretaker Heart Rate Variability (HRV) Electrocardiogram (ECG) wrist monitor and chest patch.
Measured: Through study completion, an average of 1 year
Galvanic Skin Response
Galvanic Skin Response- measuring autonomic response-via perspiration
Measured: Through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2022
- Study start1 Oct 2021
- Primary completion26 Oct 2023 (estimated)
- Study completion26 Oct 2023 (estimated)
Why it stopped: Prioritizing other studies
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypertensionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Life University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Stephanie Sullivan, DC, PhD, Study director, Life Univeristy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05312996
- Sponsor's protocol ID
- I-0017
- Status last verified
- May 2023
- First submitted
- 2 Mar 2022
- Last updated
- 3 May 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Perceived Stress and Patterns of Autonomic Function: a Protocol Development Study
- ClinicalTrials.gov ID
- NCT05312996
- Acronym / sponsor ID
- I-0017
- Conditions
- Hypertension
- Study type
- Interventional
- Recruitment status
- SuspendedReason stopped: Prioritizing other studies
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Life UniversityUniversity, hospital or other
- Study start
- 1 Oct 2021 (actual)
- Primary completion
- 26 Oct 2023 (estimated)
- Study completion
- 26 Oct 2023 (estimated)
- First posted
- 6 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hypertension | Experimental | Other: Heart Rate Variability, Other: Galvanic Skin Response (Biopac)Hypertension test group. |
| Active Comparator | Other | Other: Heart Rate Variability, Other: Galvanic Skin Response (Biopac)Non Hypertension compare group. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Heart Rate VariabilityCaretaker Heart Rate Variability ECG wrist monitor and chest patch. | Other | Active Comparator, Hypertension |
| Galvanic Skin Response (Biopac)Galvanic Skin Response- measuring autonomic response-via perspiration | Other | Active Comparator, Hypertension |
Primary outcome
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.
Galvanic Skin Response
Time frame: Through study completion, an average of 1 year
Galvanic Skin Response- measuring autonomic response-via perspiration
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 May 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stephanie Sullivan, DC, PhD study director
Life Univeristy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Heart Rate Variability and Galvanic Skin Response (Biopac) in people with Hypertension, run by Life University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: paused, as of the sponsor's last update on 3 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Heart Rate Varability (time frame: Through study completion, an average of 1 year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 May 2023.