Furlan Julio C, Yao Christie, McKay Martha, Walsh Sandra, Boulos Mark
Physical Medicine and Rehabilitation, University of Toronto, Toronto, Ontario, Canada
KITE Research Institute, University Health Network, Toronto, Ontario, Canada.
BMJ Open. 2025 Jun 6;15(6):e099266. doi: 10.1136/bmjopen-2025-099266.
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 (utcomes ost reatment: mpact on otor mpairment of leep 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).
脊髓损伤（SCI）与睡眠相关呼吸障碍（SRBDs）的发生率增加有关（截瘫后发生率≤50%，四肢瘫后发生率≤90%）。然而，脊髓损伤患者中睡眠相关呼吸障碍一直未得到充分认识和治疗。脊髓损伤优化治疗（utcomes ost reatment: mpact on otor mpairment of leep fficiency in SCI）是一项正在进行的3期临床试验，重点关注在脊髓损伤急性/亚急性期早期使用持续气道正压通气（CPAP）治疗中重度睡眠相关呼吸障碍患者的效果。
共有44名新诊断为中重度睡眠相关呼吸障碍的脊髓损伤患者被随机分为早期CPAP治疗组（伤后8周内开始）和延迟CPAP治疗组（伤后6个月开始）。无/轻度睡眠相关呼吸障碍的患者纳入对照组（n = 22）。主要结局指标包括脊髓损伤后的神经和功能恢复情况。
这项随机临床试验（RCT）的方案引发了我们研究伦理委员会关于在参与者被诊断为中重度睡眠相关呼吸障碍时将CPAP治疗延迟3个月的有趣讨论。鉴于目前的护理标准不包括对脊髓损伤康复患者进行睡眠相关呼吸障碍筛查，大多数患者在脊髓损伤慢性期进行睡眠相关呼吸障碍筛查，这意味着该人群睡眠相关呼吸障碍的诊断和治疗会有更大延迟。由于脊髓损伤优化治疗试验对当前护理标准的潜在影响超过了将CPAP治疗延迟3个月的风险，该试验方案获得批准。传播计划包括在科学会议上进行报告以及在同行评审的科学期刊上发表研究结果。
ClinicalTrials.gov（NCT05473689）。
