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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
66
Continuous positive airway pressure (CPAP) therapy for moderate-to-severe sleep-related breathing disorders.
KITE Toronto Research Institute
Toronto, Ontario, Canada
RECRUITINGChange 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)
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
Sensory assessment of dermatomes in the upper and lower extremities (224: normal; 0: no sensory function)
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
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).
Time frame: From baseline to 6 months after recruitment
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)
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
The DASS-21 scores vary from 0 (normal) to 42 (most severe symptoms of depression, anxiety and stress).
Time frame: 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.
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
Scores for the sleep disturbance, snoring, respiratory problems, sleep adequacy, and daytime somnolence dimensions range from 0 (normal) to 100.
Time frame: 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).
Time frame: From baseline to 6 months after recruitment
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