Spinal Cord Injuries Clinical Trial
Official title:
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
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 |
Verified date | May 2024 |
Source | University Health Network, Toronto |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
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). |
Country | Name | City | State |
---|---|---|---|
Canada | Lyndhurst Centre, TRI and KITE Research Institute, UHN | Toronto | Ontario |
Lead Sponsor | Collaborator |
---|---|
University Health Network, Toronto | Sunnybrook Health Sciences Centre, Western University |
Canada,
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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