Spinal Cord Injuries, Spine Disease
Conditions
Keywords
sleep apnea, sleep-related breathing disorders
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.
Interventions
Continuous positive airway pressure (CPAP) therapy for moderate-to-severe sleep-related breathing disorders.
Sponsors
Sunnybrook Health Sciences Centre
University Health Network, Toronto
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 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 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). |
| 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. |
Countries
Canada
Contacts
Primary ContactLamisa Etu, BSc
Outcome results
None listed