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| Name | Class |
|---|---|
| Sunnybrook Health Sciences Centre | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Early-CPAP therapy group | Experimental | Individuals diagnosed with moderate-to-severe sleep-related breathing disorders (SRBDs) who will start CPAP therapy within the first 6 weeks after SCI. |
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| Delayed-CPAP therapy group | Active Comparator | Individuals diagnosed with moderate-to-severe SRBDs who will start on CPAP therapy at the 5th month after SCI. |
|
| Non-CPAP therapy group | No Intervention | Individuals who are diagnosed with no or mild SRBD. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Continuous positive airway pressure (CPAP) therapy | Device | Continuous positive airway pressure (CPAP) therapy for moderate-to-severe sleep-related breathing disorders. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in International Standards for Neurological Classification of SCI (ISNCSCI) motor subscore from baseline to 6 months after recruitment | Motor assessment of muscles in the upper and lower extremities (100: normal; 0: complete paresis) | 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 | Sensory assessment of dermatomes in the upper and lower extremities (224: normal; 0: no sensory function) | From baseline to 6 months after recruitment |
| Change in Spinal Cord Independence Measure (SCIM) - version III - score 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). | From baseline to 6 months after recruitment |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Fatigue Severity Scale (FSS) from baseline to 6 months after recruitment | The FSS scores vary from 9 (normal) to 56 (the most severe degree of fatigue) | From baseline to 6 months after recruitment |
| Change in Depression, Anxiety & Stress Scales- 21 (DASS-21) score from baseline to 6 months after recruitment |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Lamisa Etu, BSc | Contact | 4165973422 | 6285 | LamisaFaria.Etu@uhn.ca |
| Name | Affiliation | Role |
|---|---|---|
| Julio C Furlan, MD, FRCPC | KITE Research Institute, University Health Network | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| KITE Toronto Research Institute | Recruiting | Toronto | Ontario | M4G 3V9 | Canada |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40480676 | Derived | 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. |
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The UHN REB needs to approve any plan to share data from this RCT.
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| ID | Term |
|---|---|
| D013119 | Spinal Cord Injuries |
| D013122 | Spinal Diseases |
| D012891 | Sleep Apnea Syndromes |
| ID | Term |
|---|---|
| D013118 | Spinal Cord Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D020196 | Trauma, Nervous System |
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| ID | Term |
|---|---|
| D045422 | Continuous Positive Airway Pressure |
| D013812 | Therapeutics |
| ID | Term |
|---|---|
| D011175 | Positive-Pressure Respiration |
| D012121 | Respiration, Artificial |
| D058109 | Airway Management |
| D012138 | Respiratory Therapy |
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The DASS-21 scores vary from 0 (normal) to 42 (most severe symptoms of depression, anxiety and stress). |
| From baseline to 6 months after recruitment |
| Change in Patient Health Questionnaire (PHQ-9) score 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. | From baseline to 6 months after recruitment |
| Change in Medical Outcomes Study Sleep Scale (MOS-SS) 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. | From baseline to 6 months after recruitment |
| Change in Montreal Cognitive Assessment (MoCA test) score from baseline to 6 months after recruitment | The MoCA test scores vary from 0 to 30 (normal). | From baseline to 6 months after recruitment |
| D014947 | Wounds and Injuries |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D001049 | Apnea |
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
| D020919 | Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |