Outcomes Post Treatment: Impact on Motor Impairment of Sleep Efficiency in SCI (OPTIMISE SCI Trial)
Recruiting now · Not applicable
Conditions studied: Spinal Cord Injuries, Spine Disease
In brief
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.
Key facts
- Study ID
- NCT05473689
- Run by
- University Health Network, Toronto
- People needed
- 66
- Starts
- 2022-08-15
- Expected to finish
- 2025-07-31
- Last updated by the study team
- 2024-12-11
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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
Where it is running
- KITE Toronto Research Institute — Toronto, Ontario, Canada (enrolling)
Full record on ClinicalTrials.gov
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