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Clinical Trials/NCT05687097
NCT05687097
Completed
Not Applicable

Untreated Sleep-related Breathing Disorders as an Aggravating Factor for Neuropathic Pain, Spasticity and Cardiovascular Dysfunction After Spinal Cord Injury: A Cross-sectional Prospective Study

University Health Network, Toronto1 site in 1 country60 target enrollmentSeptember 1, 2020

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Sleep Apnea
Sponsor
University Health Network, Toronto
Enrollment
60
Locations
1
Primary Endpoint
Apnea-hypopnea index (AHI)
Status
Completed
Last Updated
last year

Overview

Brief Summary

This cross-sectional prospective study will assess the potential association of more severe sleep apnea after spinal cord injury with more intense neuropathic pain, more severe spasticity, and more significant cardiovascular abnormalities including cardiac arrhythmias and blood pressure fluctuations. In addition, the participants' experience when undergoing home-based sleep screening test or hospital-unattended sleep screening test will be assessed in a semi-structured interview.

Detailed Description

This cross-sectional prospective study will assess the potential association of more severe sleep apnea after spinal cord injury with more intense neuropathic pain, more severe spasticity, and more significant cardiovascular abnormalities including cardiac arrhythmias and blood pressure fluctuations. In addition, the participants' experience when undergoing home-based sleep screening test or hospital-unattended sleep screening test will be assessed in a semi-structured interview (qualitative analysis).

Registry
clinicaltrials.gov
Start Date
September 1, 2020
End Date
March 31, 2024
Last Updated
last year
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Julio Furlan, MD

Clinical Investigator and Scientist

University Health Network, Toronto

Eligibility Criteria

Inclusion Criteria

  • Individuals with subacute/chronic (\> 1 month after injury) spinal cord injury.
  • Individuals with a mid-cervical/mid-thoracic (levels C5 to T6) spinal cord injury.
  • Individuals with a complete or incomplete (ASIA Impairment Scale A, B, C, or D) spinal cord injury.

Exclusion Criteria

  • individuals with other disorders of the central nervous system (e.g., sequelae of traumatic brain injury, stroke);
  • Individuals with psychiatric disorders that can interfere with adherence to study;
  • Individuals with neuromuscular diseases;
  • Individuals with history of substance abuse;
  • Individuals with prior history of hypersomnias or sleep apnea under treatment;
  • Individuals with prior history of chronic pain (e.g. fibromyalgia).

Outcomes

Primary Outcomes

Apnea-hypopnea index (AHI)

Time Frame: One night of sleep (up to 10 hours)

The number of apneas and hypopneas per hour of sleep recorded using the ApneaLink device.

Secondary Outcomes

  • Neuropathic pain(Pre-intervention assessment only.)
  • Cardiovascular dysfunction(Pre-intervention assessment only.)
  • Spasticity(Pre-intervention assessment only.)

Study Sites (1)

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