Impact of Sleep Efficiency on Motor Impairment in Spinal Cord Injury
Official title: Outcomes Post Treatment: Impact on Motor Impairment of Sleep Efficiency in SCI (OPTIMISE SCI Trial)
Run by University Health Network, Toronto · NCT05473689 · Data updated 2026-11-12
This study is testing if starting CPAP therapy early or later helps people with spinal cord injuries and sleep problems improve their movement abilities.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 66 (estimated) |
| Sponsor | University Health Network, Toronto Academic / other |
| Locations | 1 site (Toronto, Ontario) |
| Status | Recruiting |
| Started | August 15, 2022 |
| Main results expected | July 31, 2025 |
| Study ends | July 31, 2025 |
| Registry record updated | December 11, 2024 |
| Trial ID | NCT05473689 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are English-speaking adults aged 18 or older with acute cervical or thoracic spinal cord injuries who have not been treated for sleep apnea prior to their injury.
✕Probably not a fit
Patients with non-traumatic spinal cord diseases, significant psychiatric disorders, or other central nervous system diseases may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This clinical trial investigates the effects of continuous positive airway pressure (CPAP) therapy on individuals with cervical or thoracic spinal cord injuries who experience moderate-to-severe sleep-related breathing disorders. Participants will be randomly assigned to receive either early CPAP therapy at 6 weeks post-injury, delayed CPAP therapy at 22 weeks post-injury, or no treatment if they have mild or no sleep-related breathing disorders. The goal is to assess how these different approaches to managing sleep efficiency impact motor impairment outcomes in this patient population.
Why it matters
Potential benefit: If successful, this study could improve motor function and overall quality of life for patients with spinal cord injuries by effectively managing sleep-related breathing disorders.
How similar studies have gone: Other studies have shown promising results in managing sleep-related breathing disorders in similar populations, suggesting potential for success in this approach.
Who can join: the full rules
Show full inclusion / exclusion criteria
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
Where it's running
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KITE Toronto Research Institute
Toronto, Ontario, Canada Recruiting
Study contacts
- Principal investigator: Julio C Furlan, MD, FRCPC — KITE Research Institute, University Health Network
- Study coordinator: Lamisa Etu, BSc
- Email: LamisaFaria.Etu@uhn.ca
- Phone: 4165973422
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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Transcutaneous spinal cord stimulation with 4-aminopyridine and intensive rehab for chronic spinal cord injury
This pilot study tests whether combining noninvasive spinal stimulation, dalfampridine, and rigorous rehab is safe and feasible for adults with chronic spinal cord injury and whether it can help improve movement and walking.
-
NG004 for incomplete cervical spinal cord injury
This trial tests NG004 versus placebo to see if it is safe and helps motor function and daily life in adults with acute incomplete cervical spinal cord injury.
-
Robot-assisted training for arm and leg movement after stroke or injury
This study tests whether adding ZEPU-AI robotic training to usual therapy is safe and helps adults with arm or leg movement problems from stroke, spinal cord injury, brain injury, or orthopedic conditions.
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ZEPU-AI3 Lower Limb Feedback Training and Evaluation Robot in Rehab
This pilot trial tests whether adding the ZEPU-AI3 robotic leg training with real-time feedback to standard rehab helps adults with lower limb motor problems from stroke, spinal cord injury, or similar conditions.
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Combined magnetic stimulation and ultrasound for detrusor overactivity in spinal cord injury
This study tests whether using high-frequency sacral nerve stimulation together with bladder-directed ultrasound can reduce involuntary bladder contractions and improve bladder function in people with spinal cord injury.
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Hybrid HIIT-FES cycling program for people with spinal cord injury
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.