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๐Ÿ›๏ธ Verified NIH Protocol โ€ข Sourced via U.S. National Library of Medicine (Last Synced: 2024-12-11)

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

๐ŸŸข Recruiting Protocol / Phase N/A โš™๏ธ Medical Device Protocol Sponsor: University Health Network, Toronto

๐Ÿฉบ Protocol 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.

Primary Research Facility: KITE Toronto Research Institute (Toronto, Ontario)

๐Ÿ“‹ Basic Study Criteria & Logistics Checklist

0 of 3 Checked

Review these 3 basic logistical and protocol criteria extracted from the public NIH record. (This is a preliminary logistical checklist, not an official clinical eligibility determination).

๐Ÿ“ Primary Site Map

Site: KITE Toronto Research Institute โ€” Toronto, Ontario

๐Ÿ“„ Print Doctor Discussion Sheet

Preview and print a 1-page summary with 5 tailored questions for your physician.

๐Ÿ’ฐ Clinical Trial Costs & Insurance Coverage

Coverage for clinical trial participation varies depending on your health insurance policy, state legislation, and whether specific procedures are investigational research or routine medical care. Under federal law (Affordable Care Act ยง 2709), health insurers generally cannot drop coverage or refuse to pay for routine patient care costs incurred in approved clinical trials.

๐Ÿ’ก Always ask the study coordinator for the trial's official Informed Consent Form, which outlines all sponsor-funded research items versus procedures billed to your insurance.

๐Ÿ›๏ธ Official Government Provenance

NIH ClinicalTrials.gov Protocol Record

NCT Identifier: NCT05473689 โ€ข Last Synced: 2024-12-11
View on ClinicalTrials.gov โ†—
๐Ÿ“ž Call Desk ๐Ÿ“‹ Check Criteria