Psychosocial, Cognitive, and Behavioral Consequences of Sleep-disordered Breathing After S
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).
| Condition(s) | Spinal Cord Injuries, Sleep Apnea |
|---|---|
| Status | Recruiting |
| Phase | NA |
| Study type | Interventional |
| 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). |
| Who can participate | 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 |
| Ages | 18 Years |
| Sex | All |
| Lead sponsor | University Health Network, Toronto |
| Locations | Toronto, Ontario, Canada |
| Start date | 2019-09-27 |
| NCT ID | NCT04007380 |
| Official listing | https://clinicaltrials.gov/study/NCT04007380 |