Heart Rate Variability and Its Association With Symptom of Orthostatic Hypotension in Spinal Cord Injury

NCT05982652 | Unknown

• 1 other identifier: 05-2021-293
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Spinal Cord Injuries; Orthostatic Hypotension; Heart Rate Variability

Keywords

Spinal Cord Injuries; Orthostatic Hypotension; Heart rate variability; Autonomic nervous system

Outcome Measures

Primary Outcomes (2)

• 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

  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.

  at the test time (15minutes)

Study Arms (3)

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

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Individuals with SCI were recruited from a single university-affiliated rehabilitation hospital.

You may qualify if:

• spinal cord injury with or without OH
• aged 19 or older
• ASIA Impairment Scale (AIS) A to D
• neurological level of injury above T6.

You may not qualify if:

• 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

Sponsors & Collaborators

• Pusan National University Yangsan Hospital: lead

Study Sites (1)

Pusan National University Yangsan Hospital, Geumo-ro 20, Mulgeum-eup

Yangsan, Gyeongsangnam-do, 50612, South Korea

Location

Related Publications (1)

• 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.

  PMID: 30904574 BACKGROUND

MeSH Terms

Conditions

Spinal Cord Injuries; Hypotension, Orthostatic

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries; Orthostatic Intolerance; Primary Dysautonomias; Autonomic Nervous System Diseases; Hypotension; Vascular Diseases; Cardiovascular Diseases

Study Officials

• PARK HAERI, Master

  Pusan National University Yangsan Hospital

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Year
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: doctor

Study Record Dates

• First Submitted: October 13, 2022
• First Posted: August 8, 2023
• Study Start: January 1, 2022
• Primary Completion: August 31, 2023
• Study Completion: December 31, 2023
• Last Updated: August 9, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)