Outcomes Post Treatment: Impact on Motor Impairment of Sleep Efficiency in SCI (OPTIMISE SCI Trial)
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Early-CPAP therapy group Individuals diagnosed with moderate-to-severe sleep-related breathing disorders (SRBDs) who will start CPAP therapy within the first 6 weeks after SCI. |
Device: Continuous positive airway pressure (CPAP) therapy
Continuous positive airway pressure (CPAP) therapy for moderate-to-severe sleep-related breathing disorders.
|
| Active Comparator: Delayed-CPAP therapy group Individuals diagnosed with moderate-to-severe SRBDs who will start on CPAP therapy at the 5th month after SCI. |
Device: Continuous positive airway pressure (CPAP) therapy
Continuous positive airway pressure (CPAP) therapy for moderate-to-severe sleep-related breathing disorders.
|
| No Intervention: Non-CPAP therapy group Individuals who are diagnosed with no or mild SRBD. |
Outcome Measures
Primary Outcome Measures
- Change in International Standards for Neurological Classification of SCI (ISNCSCI) motor subscore from baseline to 6 months after recruitment [From baseline to 6 months after recruitment]
Motor assessment of muscles in the upper and lower extremities (100: normal; 0: complete paresis)
- Change in International from baseline to 6 months after recruitment Standards for Neurological Classification of SCI (ISNCSCI) sensory subscore [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 [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).
Secondary Outcome Measures
- Change in Fatigue Severity Scale (FSS) from baseline to 6 months after recruitment [From baseline to 6 months after recruitment]
The FSS scores vary from 9 (normal) to 56 (the most severe degree of fatigue)
- Change in Depression, Anxiety & Stress Scales- 21 (DASS-21) score from baseline to 6 months after recruitment [From baseline to 6 months after recruitment]
The DASS-21 scores vary from 0 (normal) to 42 (most severe symptoms of depression, anxiety and stress).
- Change in Patient Health Questionnaire (PHQ-9) score from baseline to 6 months after recruitment [From baseline to 6 months after recruitment]
The PHQ-9 scores vary from 0 to 27, which means: 0-4 is the normal or minimal; 5-9 if the person is mildly depressed; 10-14 if the person is moderately depressed; 15-19 if the person has moderately severe depression; and 20-27 if the person is severely depressed.
- Change in Medical Outcomes Study Sleep Scale (MOS-SS) from baseline to 6 months after recruitment [From baseline to 6 months after recruitment]
Scores for the sleep disturbance, snoring, respiratory problems, sleep adequacy, and daytime somnolence dimensions range from 0 (normal) to 100.
- Change in Montreal Cognitive Assessment (MoCA test) score from baseline to 6 months after recruitment [From baseline to 6 months after recruitment]
The MoCA test scores vary from 0 to 30 (normal).
Eligibility Criteria
Criteria
Inclusion Criteria:
-
English-speaking adults (18 years of age or older)
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Acute (≤ 30 days after injury), cervical/thoracic (injury level at C2 to T12), complete or incomplete (AIS A to D) SCI
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Not being treated for sleep apnea prior to the spinal cord impairment onset.
Exclusion Criteria:
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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)
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Concomitant diseases of the central nervous system
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Preinjury chronic pain
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Other pre-existing diseases of the central nervous system
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Significant psychiatric disorders with recent episode of exacerbation
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Neuromuscular diseases
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Current substance misuse
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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)
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Epilepsy
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Vitamin B12 deficiency
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | KITE Toronto Research Institute | Toronto | Ontario | Canada | M4G 3V9 |
Sponsors and Collaborators
- University Health Network, Toronto
- Sunnybrook Health Sciences Centre
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 21-6214