Impact of Early Versus Delayed CPAP Therapy on Sleep and Motor Recovery in Adults with Cervical or Thoracic Spinal Cord Injury

What this Trial Is About

Researchers are evaluating the impact of continuous positive airway pressure CPAP therapy on adults with cervical or thoracic spinal cord injuries SCI who have moderate-to-severe sleep-related breathing disorders SRBDs. The study compares three groups those starting early CPAP therapy within 6 weeks after SCI, those starting delayed CPAP therapy at about 22 weeks, and those with mild or no SRBD who receive no treatment. This trial aims to understand how timing of CPAP treatment may affect motor impairment and overall recovery in SCI. Participants are assigned randomly to one of three groups early CPAP therapy, delayed CPAP therapy, or no CPAP treatment. The CPAP therapy device is used to manage breathing disorders in the affected individuals. The study monitors changes from baseline to 6 months after enrollment, capturing motor and sensory scores and daily independence measures. Each group follows their assigned intervention timeline, with CPAP therapy starting either early or delayed, or no treatment for those with mild or no SRBD. During the 6-month study period, participants undergo assessments including motor and sensory function evaluations using the International Standards for Neurological Classification of SCI ISNCSCI, spinal cord independence measures, and various scales for fatigue, mood, sleep quality, and cognitive function. These evaluations take place at baseline and at 6 months to measure changes. The study is designed to track safety and effectiveness of CPAP timing on recovery after spinal cord injury.

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