Cardiovascular Complication, Neuropathic Pain, Sleep Apnea, Spasticity, Muscle, Spinal Cord Injuries
Conditions
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).
Interventions
DEVICEHome-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.
DEVICECardiovascular beat-to-beat monitoring
CareTaker device will be used to continuously record the participant's arterial blood pressure and heart rate during sleep.
DEVICEECG monitoring
Faror Bithium 180 device will be used to continuously record the participant's ECG during sleep.
Sponsors
Sunnybrook Health Sciences Centre
Western University
University Health Network, Toronto
Study design
Observational model
OTHER
Time perspective
CROSS_SECTIONAL
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Apnea-hypopnea index (AHI) | One night of sleep (up to 10 hours) | The number of apneas and hypopneas per hour of sleep recorded using the ApneaLink device. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Neuropathic pain | Pre-intervention assessment only. | Level of neuropathic pain prior to the interventions using Visual Analog Scale (0: no pain; 100: the worst pain ever). |
| Spasticity | Pre-intervention assessment only. | Degree of spasticity prior to the interventions using the modified Ashworth Scale (0: normal tone; 16: all four extremities rigid in flexion or extension). |
| Cardiovascular dysfunction | Pre-intervention assessment only. | The number of episodes of autonomic dysreflexia during sleep. |
Countries
Canada
Outcome results
None listed