Outcomes Post Treatment: Impact on Motor Impairment of Sleep Efficiency in SCI (OPTIMISE SCI Trial)
NCT ID: NCT05473689
Last Updated: 2024-12-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
66 participants
INTERVENTIONAL
2022-08-15
2025-07-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Early-CPAP therapy group
Individuals diagnosed with moderate-to-severe sleep-related breathing disorders (SRBDs) who will start CPAP therapy within the first 6 weeks after SCI.
Continuous positive airway pressure (CPAP) therapy
Continuous positive airway pressure (CPAP) therapy for moderate-to-severe sleep-related breathing disorders.
Delayed-CPAP therapy group
Individuals diagnosed with moderate-to-severe SRBDs who will start on CPAP therapy at the 5th month after SCI.
Continuous positive airway pressure (CPAP) therapy
Continuous positive airway pressure (CPAP) therapy for moderate-to-severe sleep-related breathing disorders.
Non-CPAP therapy group
Individuals who are diagnosed with no or mild SRBD.
No interventions assigned to this group
Interventions
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Continuous positive airway pressure (CPAP) therapy
Continuous positive airway pressure (CPAP) therapy for moderate-to-severe sleep-related breathing disorders.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Sunnybrook Health Sciences Centre
OTHER
University Health Network, Toronto
OTHER
Responsible Party
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Principal Investigators
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Julio C Furlan, MD, FRCPC
Role: PRINCIPAL_INVESTIGATOR
KITE Research Institute, University Health Network
Locations
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KITE Toronto Research Institute
Toronto, Ontario, Canada
Countries
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Central Contacts
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Facility Contacts
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Mitsue Aibe
Role: primary
References
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Furlan JC, Yao C, McKay M, Walsh S, Boulos M. Study protocol for the Outcomes Post-Treatment: Impact on Motor Impairment of Sleep Efficiency in Spinal Cord Injury (OPTIMISE SCI) - a randomised controlled trial. BMJ Open. 2025 Jun 6;15(6):e099266. doi: 10.1136/bmjopen-2025-099266.
Other Identifiers
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21-6214
Identifier Type: -
Identifier Source: org_study_id