NCT05473689

Outcomes Post Treatment: Impact on Motor Impairment of Sleep Efficiency in SCI (OPTIMISE SCI Trial)

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 66 (estimated)
• Sponsor: University Health Network, Toronto · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Spinal Cord Injuries
• Spine Disease

Interventions

Type	Name	Description
DEVICE	Continuous positive airway pressure (CPAP) therapy	Continuous positive airway pressure (CPAP) therapy for moderate-to-severe sleep-related breathing disorders.

Timeline

• Start date: 2022-08-15
• Primary completion: 2025-07-31
• Completion: 2025-07-31
• First posted: 2022-07-26
• Last updated: 2024-12-11

Locations

1 site across 1 country: Canada