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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05687097
Other study ID # 19-5285
Secondary ID
Status Completed
Phase
First received
Last updated
Start date September 1, 2020
Est. completion date March 31, 2024

Study information

Verified date May 2024
Source University Health Network, Toronto
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


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).


Recruitment information / eligibility

Status Completed
Enrollment 60
Est. completion date March 31, 2024
Est. primary completion date March 31, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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).

Study Design


Intervention

Device:
Home-based sleep screening test or hospital-unattended sleep screening test
ApneaLink device will be used to assess the number of apnea and hypopnea events per hour of sleep.
Cardiovascular beat-to-beat monitoring
CareTaker device will be used to continuously record the participant's arterial blood pressure and heart rate during sleep.
ECG monitoring
Faror Bithium 180 device will be used to continuously record the participant's ECG during sleep.

Locations

Country Name City State
Canada Lyndhurst Centre, TRI and KITE Research Institute, UHN Toronto Ontario

Sponsors (3)

Lead Sponsor Collaborator
University Health Network, Toronto Sunnybrook Health Sciences Centre, Western University

Country where clinical trial is conducted

Canada, 

Outcome

Type Measure Description Time frame Safety issue
Primary Apnea-hypopnea index (AHI) The number of apneas and hypopneas per hour of sleep recorded using the ApneaLink device. One night of sleep (up to 10 hours)
Secondary Neuropathic pain Level of neuropathic pain prior to the interventions using Visual Analog Scale (0: no pain; 100: the worst pain ever). Pre-intervention assessment only.
Secondary Spasticity Degree of spasticity prior to the interventions using the modified Ashworth Scale (0: normal tone; 16: all four extremities rigid in flexion or extension). Pre-intervention assessment only.
Secondary Cardiovascular dysfunction The number of episodes of autonomic dysreflexia during sleep. Pre-intervention assessment only.
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