Outcomes Post Treatment: Impact on Motor Impairment of Sleep Efficiency in SCI (OPTIMISE SCI Trial)
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Contact the study team: see the registry record → Contacts and Locations
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- Who runs it
- University Health Network, Toronto
- Trial code
- NCT05473689
- Record updated
- 11 December 2024
- Original description
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.Read full original descriptionShow less
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.
Inclusion: 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: Concomitant diseases of the central nervous system; 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); Other pre-existing diseases of the central nervous system; Significant psychiatric disorders with recent episode of exacerbation; Neuromuscular diseases; 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; Preinjury chronic pain; Current substance misuse; Vitamin B12 deficiency.