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Outcomes Post Treatment: Impact on Motor Impairment of Sleep Efficiency in SCI (OPTIMISE SCI Trial)

RecruitingNAAges 18 Years - anyAllUniversity Health Network, Toronto
NCT05473689 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
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
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What it tests

  • Continuous positive airway pressure (CPAP) therapy
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Where

1 site
KITE Toronto Research Institute
Toronto, Canada
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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