NCT05473689 Outcomes Post Treatment: Impact on Motor Impairment of Sleep Efficiency in SCI (OPTIMISE SCI Trial)
| NCT ID | NCT05473689 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University Health Network, Toronto |
| Condition | Spinal Cord Injuries |
| Study Type | INTERVENTIONAL |
| Enrollment | 66 participants |
| Start Date | 2022-08-15 |
| Primary Completion | 2025-07-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 66 participants in total. It began in 2022-08-15 with a primary completion date of 2025-07-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility 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
Contact & Investigator
Julio C Furlan, MD, FRCPC
PRINCIPAL INVESTIGATOR
KITE Research Institute, University Health Network
Frequently Asked Questions
Who can join the NCT05473689 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Spinal Cord Injuries. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05473689 currently recruiting?
Yes, NCT05473689 is actively recruiting participants. Contact the research team at LamisaFaria.Etu@uhn.ca for enrollment information.
Where is the NCT05473689 trial being conducted?
This trial is being conducted at Toronto, Canada.
Who is sponsoring the NCT05473689 clinical trial?
NCT05473689 is sponsored by University Health Network, Toronto. The principal investigator is Julio C Furlan, MD, FRCPC at KITE Research Institute, University Health Network. The trial plans to enroll 66 participants.