Impact of Sleep Efficiency on Motor Impairment in Spinal Cord Injury
Outcomes Post Treatment: Impact on Motor Impairment of Sleep Efficiency in SCI (OPTIMISE SCI Trial)
NA · University Health Network, Toronto · NCT05473689
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
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 66 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University Health Network, Toronto (other) |
| Locations | 1 site (Toronto, Ontario) |
| Trial ID | NCT05473689 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: Other studies have shown promising results in managing sleep-related breathing disorders in similar populations, suggesting potential for success in this approach.
Eligibility criteria
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 this trial is running
Toronto, Ontario
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Spinal Cord Injuries, Spine Disease, sleep apnea, sleep-related breathing disorders