Study protocol for the Outcomes Post-Treatment: Impact on Motor Impairment of Sleep Efficiency in Spinal Cord Injury (OPTIMISE SCI) – a randomised controlled trial
Introduction 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 (Outcomes Post T...
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BMJ Publishing Group
2025-06-01
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| Series: | BMJ Open |
| Online Access: | https://bmjopen.bmj.com/content/15/6/e099266.full |
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| author | Julio C Furlan Sandra Walsh Mark Boulos Christie Yao Martha McKay |
| author_facet | Julio C Furlan Sandra Walsh Mark Boulos Christie Yao Martha McKay |
| author_sort | Julio C Furlan |
| collection | DOAJ |
| description | Introduction 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 (Outcomes Post Treatment: Impact on Motor Impairment of Sleep Efficiency 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.Methods and analysis 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.Ethics and dissemination 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.Trial registration number ClinicalTrials.gov (NCT05473689). |
| format | Article |
| id | doaj-art-747e8bbb687f47dbb3aee20ec60da662 |
| institution | Kabale University |
| issn | 2044-6055 |
| language | English |
| publishDate | 2025-06-01 |
| publisher | BMJ Publishing Group |
| record_format | Article |
| series | BMJ Open |
| spelling | doaj-art-747e8bbb687f47dbb3aee20ec60da6622025-08-20T03:25:03ZengBMJ Publishing GroupBMJ Open2044-60552025-06-0115610.1136/bmjopen-2025-099266Study protocol for the Outcomes Post-Treatment: Impact on Motor Impairment of Sleep Efficiency in Spinal Cord Injury (OPTIMISE SCI) – a randomised controlled trialJulio C Furlan0Sandra Walsh1Mark Boulos2Christie Yao3Martha McKay4Physical Medicine and Rehabilitation, University of Toronto, Toronto, Ontario, CanadaLyndhurst Centre, Toronto Rehabilitation Institute, University Health Network, Toronto, Ontario, CanadaInstitute of Medical Science, Univeristy of Toronto, Toronto, Ontario, CanadaLyndhurst Centre, Toronto Rehabilitation Institute, University Health Network, Toronto, Ontario, CanadaLyndhurst Centre, Toronto Rehabilitation Institute, University Health Network, Toronto, Ontario, CanadaIntroduction 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 (Outcomes Post Treatment: Impact on Motor Impairment of Sleep Efficiency 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.Methods and analysis 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.Ethics and dissemination 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.Trial registration number ClinicalTrials.gov (NCT05473689).https://bmjopen.bmj.com/content/15/6/e099266.full |
| spellingShingle | Julio C Furlan Sandra Walsh Mark Boulos Christie Yao Martha McKay Study protocol for the Outcomes Post-Treatment: Impact on Motor Impairment of Sleep Efficiency in Spinal Cord Injury (OPTIMISE SCI) – a randomised controlled trial BMJ Open |
| title | Study protocol for the Outcomes Post-Treatment: Impact on Motor Impairment of Sleep Efficiency in Spinal Cord Injury (OPTIMISE SCI) – a randomised controlled trial |
| title_full | Study protocol for the Outcomes Post-Treatment: Impact on Motor Impairment of Sleep Efficiency in Spinal Cord Injury (OPTIMISE SCI) – a randomised controlled trial |
| title_fullStr | Study protocol for the Outcomes Post-Treatment: Impact on Motor Impairment of Sleep Efficiency in Spinal Cord Injury (OPTIMISE SCI) – a randomised controlled trial |
| title_full_unstemmed | Study protocol for the Outcomes Post-Treatment: Impact on Motor Impairment of Sleep Efficiency in Spinal Cord Injury (OPTIMISE SCI) – a randomised controlled trial |
| title_short | Study protocol for the Outcomes Post-Treatment: Impact on Motor Impairment of Sleep Efficiency in Spinal Cord Injury (OPTIMISE SCI) – a randomised controlled trial |
| title_sort | study protocol for the outcomes post treatment impact on motor impairment of sleep efficiency in spinal cord injury optimise sci a randomised controlled trial |
| url | https://bmjopen.bmj.com/content/15/6/e099266.full |
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