Outcomes Post Treatment: Impact on Motor Impairment of Sleep Efficiency in SCI (OPTIMISE SCI Trial)
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Spinal Cord Injuries
- Sponsor
- University Health Network, Toronto
- Enrollment
- 66
- Locations
- 1
- Primary Endpoint
- Change in International from baseline to 6 months after recruitment Standards for Neurological Classification of SCI (ISNCSCI) sensory subscore
- Status
- Recruiting
- Last Updated
- last year
Overview
Brief 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.
Investigators
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)
- •Vitamin B12 deficiency
Outcomes
Primary Outcomes
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
Sensory assessment of dermatomes in the upper and lower extremities (224: normal; 0: no sensory function)
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
The SCIM scores varies from 0 to 100 and includes the following subscores: self-care (0-20); respiration and sphincter management (0-40); mobility (0-40).
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
Motor assessment of muscles in the upper and lower extremities (100: normal; 0: complete paresis)
Secondary Outcomes
- Change in Fatigue Severity Scale (FSS) from baseline to 6 months after recruitment(From baseline to 6 months after recruitment)
- Change in Medical Outcomes Study Sleep Scale (MOS-SS) from baseline to 6 months after recruitment(From baseline to 6 months after recruitment)
- Change in Depression, Anxiety & Stress Scales- 21 (DASS-21) score from baseline to 6 months after recruitment(From baseline to 6 months after recruitment)
- Change in Patient Health Questionnaire (PHQ-9) score from baseline to 6 months after recruitment(From baseline to 6 months after recruitment)
- Change in Montreal Cognitive Assessment (MoCA test) score from baseline to 6 months after recruitment(From baseline to 6 months after recruitment)