Actively Recruiting
Outcomes Post Treatment: Impact on Motor Impairment of Sleep Efficiency in SCI (OPTIMISE SCI Trial)
Led by University Health Network, Toronto · Updated on 2024-12-11
66
Participants Needed
1
Research Sites
154 weeks
Total Duration
On this page
Sponsors
U
University Health Network, Toronto
Lead Sponsor
S
Sunnybrook Health Sciences Centre
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Outcomes Post Treatment: Impact on Motor Impairment of Sleep Efficiency in SCI (OPTIMISE SCI Trial)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- English-speaking adults 18 years of age or older
- Acute spinal cord injury within 30 days of injury
- Injury level between C2 and T12, complete or incomplete (AIS A to D)
- Not previously treated for sleep apnea before spinal cord injury onset
You will not qualify if you...
- Non-traumatic spinal cord diseases at risk of neurological progression (e.g., neuromyelitis optica, multiple sclerosis, spinal cord malignancy)
- Other diseases of the central nervous system
- Preexisting chronic pain before injury
- Significant psychiatric disorders with recent exacerbation
- Neuromuscular diseases
- Current substance misuse
- Known history of primary or secondary hypersomnia except for sleep-related breathing disorders
- Epilepsy
- Vitamin B12 deficiency
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
KITE Toronto Research Institute
Toronto, Ontario, Canada, M4G 3V9
Actively Recruiting
Research Team
L
Lamisa Etu, BSc
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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