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

NCT05473689 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 66

Last updated 2024-12-11

No results posted yet for this study

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.

Conditions

  • Spinal Cord Injuries
  • Spine Disease

Interventions

DEVICE

Continuous positive airway pressure (CPAP) therapy

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

Sponsors & Collaborators

  • Sunnybrook Health Sciences Centre

    collaborator OTHER

  • University Health Network, Toronto

    lead OTHER

Principal Investigators

  • Julio C Furlan, MD, FRCPC · KITE Research Institute, University Health Network

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-08-15
Primary Completion
2025-07-31
Completion
2025-07-31

Countries

  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05473689 on ClinicalTrials.gov