This randomized clinical trial will compare three groups of individuals with cervical/thoracic, complete or incomplete spinal cord injury (SCI) that will undergo: (i) early CPAP therapy in the management of moderate-to-severe sleep-related breathing disorders (SRBDs) among adults at 6 weeks after SCI; (ii) delayed CPAP therapy in the management of moderate-to-severe SRBDs among adults at 22 weeks after SCI; and (iii) no treatment as they either have mild or no SRBD.
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria:
* English-speaking adults (18 years of age or older)
* Acute (≤ 30 days after injury), cervical/thoracic (injury level at C2 to T12), complete or incomplete (AIS A to D) SCI
* Not being treated for sleep apnea prior to the spinal cord impairment onset.
Exclusion Criteria:
* Non-traumatic spinal cord disease at risk for neurologic progression (e.g., demyelinating spine diseases such as neuromyelitis optica and multiple sclerosis, spinal cord malignancy)
* Concomitant diseases of the central nervous system
* Preinjury chronic pain
* Other pre-existing diseases of the central nervous system
* Significant psychiatric disorders with recent episode of exacerbation
* Neuromuscular diseases
* Current substance misuse
* Known history of primary hypersomnia or secondary hypersomnia of any cause except for SRBDs (e.g., hypothyroidism, moderate or severe iron deficiency anemia, infections, depression, kidney failure, chronic fatigue syndrome, neurodegenerative diseases, and myotonic dystrophy)
* Epilepsy
* Vitamin B12 deficiency
Primary outcome measure(s)
Change in International Standards for Neurological Classification of SCI (ISNCSCI) motor subscore from baseline to 6 months after recruitment — From baseline to 6 months after recruitment Motor assessment of muscles in the upper and lower extremities (100: normal; 0: complete paresis)
Change in International from baseline to 6 months after recruitment Standards for Neurological Classification of SCI (ISNCSCI) sensory subscore — From baseline to 6 months after recruitment Sensory assessment of dermatomes in the upper and lower extremities (224: normal; 0: no sensory function)
Change in Spinal Cord Independence Measure (SCIM) - version III - score from baseline to 6 months after recruitment — From baseline to 6 months after recruitment The SCIM scores varies from 0 to 100 and includes the following subscores: self-care (0-20); respiration and sphincter management (0-40); mobility (0-40).
Trial sites (1)
Facility
City
Region
Status
KITE Toronto Research Institute
Toronto
Ontario
Recruiting
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This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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