An interventional study of Continuous positive airway pressure (CPAP) therapy in Spinal Cord Injuries and Spine Disease, sponsored by University Health Network, Toronto. Recruiting at 1 site in Canada. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-12-11.
Sponsored by University Health Network, Toronto · Not applicable, Interventional, and Treatment
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.
2,025 studies on the registry are indexed under Spinal Cord Injuries; 537 are open to participants now.
This study's planned enrollment of 66 is above the median of 24 across 1,633 interventional studies indexed under Spinal Cord Injuries.
Browse Spinal Cord Injuries studies →University Health Network, Toronto is the lead sponsor of 1,438 studies on the registry; 297 are open to participants now.
Of its 17 completed or terminated interventional studies of FDA-regulated products, 3 (18%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Individuals diagnosed with moderate-to-severe sleep-related breathing disorders (SRBDs) who will start CPAP therapy within the first 6 weeks after SCI.
Device: Continuous positive airway pressure (CPAP) therapy
Individuals diagnosed with moderate-to-severe SRBDs who will start on CPAP therapy at the 5th month after SCI.
Device: Continuous positive airway pressure (CPAP) therapy
Individuals who are diagnosed with no or mild SRBD.
Continuous positive airway pressure (CPAP) therapy for moderate-to-severe sleep-related breathing disorders.
Change 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
Plan to share: No — The UHN REB needs to approve any plan to share data from this RCT.
No publications or documents are linked to this record.
Started Aug 2022 (actual). Primary completion is estimated for Jul 2025, 35 months after the start.
Of 790 non-industry interventional studies with no phase under Spinal Cord Injuries, half reached primary completion within 37 months of starting (the median), counting those still running; a quarter within 18 and three quarters within 65. This study's planned 35 months is close to that.
Counting every sponsor, half of 839 studies reached it within 36 months; a quarter within 17 and three quarters within 64.
How these figures are worked out, and which studies are left out of them.
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