Spinal Cord InjuriesNCT05982652
Heart Rate Variability and Its Association With Symptom of Orthostatic Hypotension in Spinal Cord Injury
An observational study of Spinal Cord Injuries and Orthostatic Hypotension, run by Pusan National University Yangsan Hospital at 1 site in South Korea.
Trial summary
In this study, the SCI patients were sub-grouped on the basis of symptoms into symptomatic and asymptomatic groups and measured HRV during resting and tilt up tests to compare their cardiovascular autonomic functions. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Spinal Cord Injuries, Orthostatic Hypotension, Heart Rate Variability
- How many people
- 30 participants
- Where
- 1 siteSouth Korea
- Study dates
- 1 Jan 2022to 31 Dec 2023
- How long will I take part?
- 1 Year
- Phase
- Observational
- 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 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Individuals with SCI were recruited from a single university-affiliated rehabilitation hospital.
Who may be able to join
- spinal cord injury with or without OH
- aged 19 or older
- ASIA Impairment Scale (AIS) A to D
- neurological level of injury above T6.
Who cannot join
- Those with heart and respiratory diseases, neurological diseases other than SCI - medically unstable states
- Those who are taking medications affecting BP that cannot be stopped
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Pusan National University Yangsan Hospital, Geumo-ro 20, Mulgeum-eup
Yangsan, Gyeongsangnam-do, 50612
About this study
In this study, the SCI patients were sub-grouped on the basis of symptoms into symptomatic and asymptomatic groups and measured HRV during resting and tilt up tests to compare their cardiovascular autonomic functions.
Read the detailed description
In study protocol and the subjects were asked to lie down quietly for 5 minutes, closing their eyes and avoiding talking, moving hand, legs and body, and coughing during the test. R-R interval and blood pressure were measured beat-to-beat using Finometer® PRO (Finapres Medical Systems, Amsterdam, Netherlands) for 6 minutes each in two positions, supine and 60-degree angle on the tilt table.
- Keywords
- Spinal Cord Injuries, Orthostatic Hypotension, Heart rate variability, Autonomic nervous system
- Medical subject headings
- Spinal Cord Injuries, Hypotension, Orthostatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| non-OH group | without orthostaric hypotension in spinal cord injuries | |
| symptomatic OH group | Symptomatic individuals in a patient population diagnosed with orthostatic hypotension (Symptom : dizziness, visual disturbance, nausea and headache) | |
| asymptomatic OH group | Asymptomatic individuals in a patient population diagnosed with orthostatic hypotension |
What is being measured
The primary outcome is the main question the study is designed to answer.
Differences of heart rate variability between groups (OH vs non-OH, asymptomatic-OH vs symptomatic-OH group)
mean HR (heart rate), mean RR(RR interval), RMSSD (mean square of the successive R-R interval differences), SDNN (standard deviation of normal-to-normal interval), LF (low frequency) domain, HF(High frequency) domain
Measured: at the test time (15minutes)
Logistic regression analysis of heart rate variability variables according to OH and presence of symptom
the investigators conducted logistic regression analysis to evaluate the significance and impact of HRV variables associated with orthostatic hypotension and its symptoms in spinal cord injury patients.
Measured: at the test time (15minutes)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2023
- Study start1 Jan 2022
- Primary completion31 Aug 2023 (estimated)
- Study completion31 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Spinal Cord InjuriesStudies 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
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 30 participants (estimated)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Pusan National University Yangsan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hae-ri Park, Pusan National University Yangsan Hospital
- Investigators
- PARK HAERI, Master, Study director, Pusan National University Yangsan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05982652
- Sponsor's protocol ID
- 05-2021-293
- Status last verified
- Aug 2023
- First submitted
- 13 Oct 2022
- Last updated
- 9 Aug 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Stampas A, Zhu L, Li S. Heart rate variability in spinal cord injury: Asymptomatic orthostatic hypotension is a confounding variable. Neurosci Lett. 2019 Jun 11;703:213-218. doi: 10.1016/j.neulet.2019.03.020. Epub 2019 Mar 20.
PubMed 30904574
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Heart Rate Variability and Its Association With Symptom of Orthostatic Hypotension in Spinal Cord Injury
- ClinicalTrials.gov ID
- NCT05982652
- Acronym / sponsor ID
- 05-2021-293
- Keywords
- Spinal Cord Injuries, Orthostatic Hypotension, Heart rate variability, Autonomic nervous system
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Pusan National University Yangsan HospitalUniversity, hospital or other
- Study start
- 1 Jan 2022 (actual)
- Primary completion
- 31 Aug 2023 (estimated)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 8 Aug 2023 (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.
In this study, the SCI patients were sub-grouped on the basis of symptoms into symptomatic and asymptomatic groups and measured HRV during resting and tilt up tests to compare their cardiovascular autonomic functions.
Detailed description
In study protocol and the subjects were asked to lie down quietly for 5 minutes, closing their eyes and avoiding talking, moving hand, legs and body, and coughing during the test. R-R interval and blood pressure were measured beat-to-beat using Finometer® PRO (Finapres Medical Systems, Amsterdam, Netherlands) for 6 minutes each in two positions, supine and 60-degree angle on the tilt table.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Target follow-up
- 1 Year
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| non-OH group | – | –without orthostaric hypotension in spinal cord injuries |
| symptomatic OH group | – | –Symptomatic individuals in a patient population diagnosed with orthostatic hypotension (Symptom : dizziness, visual disturbance, nausea and headache) |
| asymptomatic OH group | – | –Asymptomatic individuals in a patient population diagnosed with orthostatic hypotension |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Individuals with SCI were recruited from a single university-affiliated rehabilitation hospital.
Key inclusion criteria (4 listed)
- spinal cord injury with or without OH
- aged 19 or older
- ASIA Impairment Scale (AIS) A to D
- neurological level of injury above T6.
Key exclusion criteria (2 listed)
- Those with heart and respiratory diseases, neurological diseases other than SCI - medically unstable states
- Those who are taking medications affecting BP that cannot be stopped
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Differences of heart rate variability between groups (OH vs non-OH, asymptomatic-OH vs symptomatic-OH group)
Time frame: at the test time (15minutes)
mean HR (heart rate), mean RR(RR interval), RMSSD (mean square of the successive R-R interval differences), SDNN (standard deviation of normal-to-normal interval), LF (low frequency) domain, HF(High frequency) domain
Logistic regression analysis of heart rate variability variables according to OH and presence of symptom
Time frame: at the test time (15minutes)
the investigators conducted logistic regression analysis to evaluate the significance and impact of HRV variables associated with orthostatic hypotension and its symptoms in spinal cord injury patients.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Aug 2023.
- Background: PubMed 30904574Stampas A, Zhu L, Li S. Heart rate variability in spinal cord injury: Asymptomatic orthostatic hypotension is a confounding variable. Neurosci Lett. 2019 Jun 11;703:213-218. doi: 10.1016/j.neulet.2019.03.020. Epub 2019 Mar 20.
- Individual participant dataSharing planned: No
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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.
PARK HAERI, Master study director
Pusan National University Yangsan Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Spinal Cord Injuries and Orthostatic Hypotension, run by Pusan National University Yangsan Hospital at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. 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: status not confirmed, as of the sponsor's last update on 9 Aug 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 South Korea. 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?
Differences of heart rate variability between groups (OH vs non-OH, asymptomatic-OH vs symptomatic-OH group) (time frame: at the test time (15minutes)). 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?
On the ClinicalTrials.gov record for NCT05982652, which also lists 1 linked publication.
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 9 Aug 2023.