Spinal Cord Injuries Clinical Trial
Official title:
Sleep Apnea in Paralympic Ontario-Resident aThletes With Spinal Cord Injury (SPORTS) Study
This single arm clinical trial will assess whether continuous positive airway pressure (CPAP) therapy in the management of moderate-to-severe sleep-related breathing disorders (SRBDs) among para-athletes living with cervical/thoracic, complete or incomplete spinal cord injury (SCI) is effective in improving cognitive impairment, in reducing fatigue, depression, anxiety, and overall quality of life. Further, the study will evaluate the effectiveness of CPAP therapy in improving their performance in sports and the perceived risk of injuries.
Status | Recruiting |
Enrollment | 15 |
Est. completion date | December 2025 |
Est. primary completion date | August 2025 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Individuals with a cervical or thoracic, complete or incomplete (AIS A to D), chronic (> 6 months) SCI; - English-speaking adults (18 years of age or older); and - Play a wheelchair sport at a high-performance level. Exclusion Criteria: - A previous history of diagnosis and treatment for sleep apnea; - Concomitant diseases of the central nervous system and other pre-existing diseases of the central nervous system; - Current substance misuse; - History of primary hypersomnia, or secondary hypersomnia of any cause except for SRBDs. - Conditions that might prevent participants to follow the study protocol. |
Country | Name | City | State |
---|---|---|---|
Canada | Toronto Rehab - Lyndhurst Centre | Toronto | Ontario |
Lead Sponsor | Collaborator |
---|---|
University Health Network, Toronto | Sunnybrook Health Sciences Centre |
Canada,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Fatigue Severity Scale | Self-reported (or administered by an interviewer) scale where participants choose one of seven levels of agreement for each question. Range from 9 (best outcome) to 63 (worst outcome). | Change in Fatigue Severity Scale from baseline to after 4-month period of CPAP therapy | |
Primary | Karolinska Sleepiness Scale | Measure the level of daytime sleepiness. The scores vary from 1 (normal) to 10 (extremely sleepy). | Change in Karolinska Sleepiness Scale from baseline to after 4-month period of CPAP therapy | |
Primary | Medical Outcomes Study Sleep Scale | Scores for the sleep disturbance, snoring, respiratory problems, sleep adequacy, and daytime somnolence dimensions range from 0 (normal) to 100. | Change in Medical Outcomes Study Sleep Scale from baseline to after 4-month period of CPAP therapy | |
Primary | Depression, Anxiety & Stress Scales- 21 | Self-reported (or administered by an interviewer) scale where participants rate questions on depression, anxiety and stress. The DASS-21 scores vary from 0 (normal) to 42 (most severe symptoms of depression, anxiety and stress). | Change in Depression, Anxiety & Stress Scales- 21 from baseline to after 4-month period of CPAP therapy | |
Primary | Craig Handicap Assessment and Recording Technique | The CHART assesses capability in 6 domains as follow: physical independence, cognitive independence, mobility, occupation, social integration, and economic self-sufficiency. The scoring for each CHART dimension varies from 0 to 100 points (normal) | Change in Craig Handicap Assessment and Recording Technique from baseline to after 4-month period of CPAP therapy | |
Primary | SF-36 | Patient-reported (or administrated by an interviewer) questionnaire that assesses 8 domains with regards to physical functioning, role limitations due to physical health problems, bodily pain, general health, vitality, social functioning, role limitations due to emotional problems, and mental health. | Change in SF-36 from baseline to after 4-month period of CPAP therapy | |
Primary | Montreal Cognitive Assessment | The Montreal Cognitive Assessment test assess cognitive impairment and scores vary from 0 (worst outcome) to 30 (best outcome). | Change in Montreal Cognitive Assessment (MoCA) score from baseline to after 4-month period of CPAP therapy | |
Primary | Recovery-Stress Questionnaire for Athletes (RESTQ-Sport) | Assess perceived stress and recovery among athletes. Responses vary from 0 (never) to 6 (always) indicating the frequency of various activities during the past three days and nights. The RESTQ-Sport scores can vary from 0 (best outcome) to 462 (worst outcome). | aseline (before CPAP therapy) and follow-up assessment (after completion of the 4-month trial of CPAP therapy) | |
Primary | Acute Recovery and Stress Scale (ARSS) | Consists of questions on recovery and stress. The participants are instructed to rate how much each expression applies to them at that moment with responses ranging from 0 (does not apply at all) to 6 (fully applies). The ARSS can vary from 0 (worst outcome) to 192 (best outcome). | Change in Acute Recovery and Stress Scale from baseline to after 4-month period of CPAP therapy | |
Primary | Sport Performance Test | Sports performance using physiologic tests: Graded Exercise Test (GXT) with VO2 and Sprint Test (Wingate), which will be performed in the physiology laboratory at the Canadian Sport Institute. | Change in Sport Performance Test from baseline to after 4-month period of CPAP therapy |
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