Actively Recruiting
Led by University Health Network, Toronto · Updated on 2024-12-11
66
Participants Needed
1
Research Sites
N/A
Total Duration
U
University Health Network, Toronto
Lead Sponsor
S
Sunnybrook Health Sciences Centre
Collaborating Sponsor
Researchers are evaluating the impact of continuous positive airway pressure (CPAP) therapy on adults with cervical or thoracic spinal cord injuries (SCI) who have moderate-to-severe sleep-related breathing disorders (SRBDs). The study compares three groups: those starting early CPAP therapy within 6 weeks after SCI, those starting delayed CPAP therapy at about 22 weeks, and those with mild or no SRBD who receive no treatment. This trial aims to understand how timing of CPAP treatment may affect motor impairment and overall recovery in SCI. Participants are assigned randomly to one of three groups: early CPAP therapy, delayed CPAP therapy, or no CPAP treatment. The CPAP therapy device is used to manage breathing disorders in the affected individuals. The study monitors changes from baseline to 6 months after enrollment, capturing motor and sensory scores and daily independence measures. Each group follows their assigned intervention timeline, with CPAP therapy starting either early or delayed, or no treatment for those with mild or no SRBD. During the 6-month study period, participants undergo assessments including motor and sensory function evaluations using the International Standards for Neurological Classification of SCI (ISNCSCI), spinal cord independence measures, and various scales for fatigue, mood, sleep quality, and cognitive function. These evaluations take place at baseline and at 6 months to measure changes. The study is designed to track safety and effectiveness of CPAP timing on recovery after spinal cord injury.
CONDITIONS
Outcomes Post Treatment: Impact on Motor Impairment of Sleep Efficiency in SCI (OPTIMISE SCI Trial)
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Complete this quick 3-step screening to check your eligibility
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 6 months after recruitment
Participants diagnosed with moderate-to-severe sleep-related breathing disorders receive Continuous Positive Airway Pressure (CPAP) therapy starting either early within 6 weeks after spinal cord injury or delayed at 5 months post-injury. Participants with no or mild sleep-related breathing disorders do not receive CPAP therapy.
Regular visits as per group assignment
Total: 1 location
1
KITE Toronto Research Institute
Toronto, Ontario, Canada, M4G 3V9
Actively Recruiting
L
Lamisa Etu, BSc
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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Julio C Furlan, Christie Yao, Martha McKay...
https://pubmed.ncbi.nlm.nih.gov/40480676