RecruitingNot ApplicableNCT05473689

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


Sponsor

University Health Network, Toronto

Enrollment

66 participants

Start Date

Aug 15, 2022

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study (OPTIMISE SCI) investigates whether improving sleep quality in people with a recent spinal cord injury (SCI) can help their motor recovery. Participants will be monitored for sleep problems like sleep apnea and their impact on physical rehabilitation outcomes. You may be eligible if: - You are an English-speaking adult (18+) - You had a spinal cord injury within the last 30 days (cervical or thoracic, C2 to T12 level) - Your injury is classified as AIS A through D (complete or incomplete) - You were not being treated for sleep apnea before your injury You may NOT be eligible if: - Your spinal cord condition is non-traumatic and likely to progress (e.g., MS, spinal cord tumor) - You have other diseases of the central nervous system - You had chronic pain before the injury - You have significant psychiatric disorders, neuromuscular diseases, or substance misuse - You have epilepsy, vitamin B12 deficiency, or a known sleep disorder other than sleep-disordered breathing Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEContinuous positive airway pressure (CPAP) therapy

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


Locations(1)

KITE Toronto Research Institute

Toronto, Ontario, Canada

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NCT05473689


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