Improving sleep-related issues in spinal cord injury patients with CPAP therapy
Official title: Psychosocial, Cognitive, and Behavioral Consequences of Sleep-disordered Breathing in Spinal Cord Injured People
Run by University Health Network, Toronto · NCT04007380 · Data updated 2026-11-12
This study is testing if using CPAP therapy at night can help improve sleep problems and overall well-being in adults with spinal cord injuries who have breathing issues during sleep.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 24 (estimated) |
| Sponsor | University Health Network, Toronto Academic / other |
| Locations | 1 site (Toronto, Ontario) |
| Status | Recruiting |
| Started | September 27, 2019 |
| Main results expected | August 30, 2025 |
| Study ends | August 30, 2025 |
| Registry record updated | December 11, 2024 |
| Trial ID | NCT04007380 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are English-speaking adults aged 18 and older with traumatic cervical or thoracic spinal cord injuries who have not been diagnosed with a sleep disorder prior to their injury.
✕Probably not a fit
Patients with non-traumatic spinal cord diseases, significant psychiatric disorders, or other serious health conditions may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This clinical trial investigates the effectiveness of continuous positive airway pressure (CPAP) therapy in addressing the psychosocial, cognitive, and behavioral impacts of sleep-related breathing disorders (SRBDs) in individuals with spinal cord injuries (SCI). The study will involve a single-arm trial with 24 adults who have moderate-to-severe SRBDs, assessing the impact of nightly CPAP use over four months. Additionally, it will explore the challenges faced by participants during the diagnosis and treatment process. The goal is to enhance fatigue, mood, cognition, quality of life, and social participation among this population.
Why it matters
Potential benefit: If successful, this study could significantly improve the quality of life and mental health of patients with spinal cord injuries by effectively managing their sleep-related breathing disorders.
How similar studies have gone: While the specific approach of using CPAP therapy for this population is less explored, similar studies have shown positive outcomes in managing sleep disorders in other patient groups.
Who can join: the full rules
Show full inclusion / exclusion 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
Where it's running
-
Lyndhurst Centre, KITE - TRI UHN
Toronto, Ontario, Canada Recruiting
Study contacts
- Principal investigator: Julio Furlan, MD — Toronto Rehabilitation Institute
- Study coordinator: Mitsue Aibe, MD
- Email: Mitsue.Aibe@uhn.ca
- Phone: 4165973422
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.