Study protocol for the Outcomes Post-Treatment: Impact on Motor Impairment of Sleep Efficiency in Spinal Cord Injury (OPTIMISE SCI) - a randomised controlled trial.

Abstract

Spinal cord injury (SCI) has been linked to increased frequencies of sleep-related breathing disorders (SRBDs) (≤50% after paraplegia and ≤90% following tetraplegia). However, SRBDs have been under-recognised and undertreated among individuals with SCI. The OPTIMISE SCI (<i>O</i>utcomes <i>P</i>ost <i>T</i>reatment: <i>I</i>mpact on <i>M</i>otor <i>I</i>mpairment of <i>S</i>leep <i>E</i>fficiency in SCI) is an ongoing phase 3 clinical trial focused on the effects of the early use of continuous positive airway pressure (CPAP) therapy to treat individuals with moderate-to-severe SRBDs in the acute/subacute stage after SCI. A total of 44 participants with SCI who are newly diagnosed with moderate-to-severe SRBD are randomised into early CPAP therapy (initiated within the first 8 weeks postinjury) versus delayed CPAP therapy (initiated at 6 months postinjury). Participants with no/mild SRBDs are included in the control group (n=22). Primary outcome measures include neurological and functional recovery after SCI. The protocol for this randomised clinical trial (RCT) raised an interesting discussion with our research ethics board about delaying CPAP therapy by 3 months when a participant is diagnosed with moderate-to-severe SRBD. Given that the current standard of care does not include screening for SRBDs in individuals who are admitted for spinal cord rehabilitation, most individuals are screened for SRBDs during the chronic stage post-SCI, which represents a greater delay in the diagnosis and treatment of SRBDs in this population. Because the potential impact of the OPTIMISE SCI trial on the current standard of care outweighs the risk of delaying CPAP therapy by 3 months, this trial protocol was approved. The dissemination plan includes presentations at scientific meetings and publication of the results in a peer-reviewed scientific journal. ClinicalTrials.gov (NCT05473689).