NCT04007380 Psychosocial, Cognitive, and Behavioral Consequences of Sleep-disordered Breathing After SCI
| NCT ID | NCT04007380 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University Health Network, Toronto |
| Condition | Spinal Cord Injuries |
| Study Type | INTERVENTIONAL |
| Enrollment | 24 participants |
| Start Date | 2019-09-27 |
| Primary Completion | 2025-08-30 |
Trial Parameters
Eligibility Fast-Check
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Brief Summary
This clinical trial will examine the efficacy of continuous positive airway pressure (CPAP) therapy in improving psychosocial, neurocognitive and behavioral consequences of moderate-to-severe sleep-related breathing disorders (SRBDs) in people living with spinal cord injury (SCI).
Eligibility Criteria
Inclusion Criteria: * English-speaking adults 18 years of age or older * Have traumatic cervical/thoracic (injury level at C5 to T10), severe or moderate (AIS A, B, or C) SCI who were not diagnosed with a sleep disorder prior to the injury. * At least 2 months after injury * Clinical warning symptoms and/or signs for SRBDs Exclusion Criteria: * Patients with a non-traumatic spinal cord disease at risk for neurologic progression * Concomitant diseases of the central nervous system * Preinjury chronic pain * Psychiatric disorders that may prevent the participant to be compliant to the study protocol requirements * Neuromuscular diseases * Current substance misuse * History of primary hypersomnia * Hypothyroidism * Moderate or severe iron deficiency anemia * Active infection * Kidney failure * Epilepsy * Chronic fatigue syndrome * Vitamin B12 deficiency