Outcomes Post Treatment: Impact on Motor Impairment of Sleep Efficiency in SCI (OPTIMISE SCI Trial) (NCT05473689)
🩺 Plain-English Summary (8th-Grade Level)
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.
Who can join: To join this study, participants generally need to meet the listed inclusion criteria (3 items) and avoid the listed exclusions (11 items).
Location: KITE Toronto Research Institute — Toronto, Ontario
Age range: 18 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistCheck every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).
Usually NOT eligible if any of the following apply:
- 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
🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.
📍 All Participating Trial Locations (1 Sites)
- KITE Toronto Research Institute — Toronto, Ontario
📞 Contact the Study Coordinator
Phone: (416) 597-3422
Email: LamisaFaria.Etu@uhn.ca
Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
More studies in Spinal Cord Injuries
- Remote Ischemic Conditioning for PwSCI — St Louis, Missouri
- Use of Point-of-care Neuro-sacral Electrophysiology Following Spinal Cord Injury — Montreal, Quebec
- Activity-Based Therapy and Transcutaneous Spinal Cord Stimulation After Spinal Cord Injury (ABT-TCSCS) — Toronto, Ontario
- Restoring Motor and Sensory Hand Function in Tetraplegia Using a Neural Bypass System — Manhasset, New York
- Closed-Loop Deep Brain Stimulation for Refractory Chronic Pain — San Francisco, California
Explore by condition: All Spinal Cord Injuries clinical trials
💡 How to Participate
- Check the checklist above to see if you may qualify.
- Contact the study coordinator using the phone/email above.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.