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Recruiting NCT05473689

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

No phase Interventional Spinal Cord Injuries Spine Disease

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Continuous positive airway pressure (CPAP) therapy.
Who it may be relevant to
Registry conditions: Spinal Cord Injuries, Spine Disease. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Canada
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Overview

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.

Interventions

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

Primary outcome measures

  • Change in International Standards for Neurological Classification of SCI (ISNCSCI) motor subscore from baseline to 6 months after recruitment [Time frame: From baseline to 6 months after recruitment]
  • Change in International from baseline to 6 months after recruitment Standards for Neurological Classification of SCI (ISNCSCI) sensory subscore [Time frame: From baseline to 6 months after recruitment]
  • Change in Spinal Cord Independence Measure (SCIM) - version III - score from baseline to 6 months after recruitment [Time frame: From baseline to 6 months after recruitment]
Secondary outcome measures (5)
  • Change in Fatigue Severity Scale (FSS) from baseline to 6 months after recruitment [Time frame: From baseline to 6 months after recruitment]
  • Change in Depression, Anxiety & Stress Scales- 21 (DASS-21) score from baseline to 6 months after recruitment [Time frame: From baseline to 6 months after recruitment]
  • Change in Patient Health Questionnaire (PHQ-9) score from baseline to 6 months after recruitment [Time frame: From baseline to 6 months after recruitment]
  • Change in Medical Outcomes Study Sleep Scale (MOS-SS) from baseline to 6 months after recruitment [Time frame: From baseline to 6 months after recruitment]
  • Change in Montreal Cognitive Assessment (MoCA test) score from baseline to 6 months after recruitment [Time frame: From baseline to 6 months after recruitment]

Eligibility criteria

Inclusion criteria

  • English-speaking adults (18 years of age or older)
  • Acute (≤ 30 days after injury), cervical/thoracic (injury level at C2 to T12), complete or incomplete (AIS A to D) SCI
  • Not being treated for sleep apnea prior to the spinal cord impairment onset.

Exclusion criteria

  • Non-traumatic spinal cord disease at risk for neurologic progression (e.g., demyelinating spine diseases such as neuromyelitis optica and multiple sclerosis, spinal cord malignancy)
  • Concomitant diseases of the central nervous system
  • Preinjury chronic pain
  • Other pre-existing diseases of the central nervous system
  • Significant psychiatric disorders with recent episode of exacerbation
  • Neuromuscular diseases
  • Current substance misuse
  • Known history of primary hypersomnia or secondary hypersomnia of any cause except for SRBDs (e.g., hypothyroidism, moderate or severe iron deficiency anemia, infections, depression, kidney failure, chronic fatigue syndrome, neurodegenerative diseases, and myotonic dystrophy)
  • Epilepsy
  • Vitamin B12 deficiency

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Treatment

Study locations

Canada · 1 center
  • KITE Toronto Research Institute — Toronto

Publications

  • Furlan JC, Yao C, McKay M, Walsh S, Boulos M. 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. 2025 Jun 6;15(6):e099266. doi: 10.1136/bmjopen-2025-099266. PMID 40480676

Identifiers

NCT: NCT05473689 · 21-6214

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗