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| Name | Class |
|---|---|
| Sunnybrook Health Sciences Centre | OTHER |
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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.
Untreated moderate-to-severe SRBDs are associated with an increased risk of stroke, heart attack, diabetes, and kidney problems. For para-athletes living with SCI, it can have a major negative impact on their performance when practicing and playing sports.
CPAP therapy is the treatment of choice for moderate-to-severe SRBD (or sleep apnea) in accordance with current good medical practices.
Therefore, the aim of the study is to determine whether CPAP therapy in para-athletes living with SCI who developed moderate-to-severe SRBDs is effective in improving memory, psychosocial implications, social and work participation, and performance in sports.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CPAP Therapy | Experimental | Participants who are diagnosed with moderate-to-severe sleep related breathing disorders (SRBDs) will undergo a 4-month trial of Continuous positive airway pressure (CPAP) therapy. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CPAP Therapy | Device | Continuous positive airway pressure (CPAP) therapy in the management of moderate-to-severe sleep-related breathing disorders (SRBDs)/sleep apnea. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Abrity Gomes | Contact | 4165973422 | 6285 | abrity.gomes@uhn.ca |
| Mitsue Aibe | Contact | 4165973422 | 6285 | Mitsue.Aibe@uhn.ca |
| Name | Affiliation | Role |
|---|---|---|
| Dr. Julio Furlan | University Health Network, Toronto | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Toronto Rehab - Lyndhurst Centre | Recruiting | Toronto | Ontario | M4G 3V9 | Canada |
The UHN REB needs to approve any plan to share data from this study.
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| ID | Term |
|---|---|
| D012891 | Sleep Apnea Syndromes |
| D012893 | Sleep Wake Disorders |
| D013119 | Spinal Cord Injuries |
| D013122 | Spinal Diseases |
| ID | Term |
|---|---|
| D001049 | Apnea |
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
| D020919 | Sleep Disorders, Intrinsic |
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Device: Continuous positive airway pressure (CPAP) therapy
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| 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 |
| 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 |
| 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) |
| 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 |
| 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 |
| D020920 |
| Dyssomnias |
| D009422 | Nervous System Diseases |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001523 | Mental Disorders |
| D013118 | Spinal Cord Diseases |
| D002493 | Central Nervous System Diseases |
| D020196 | Trauma, Nervous System |
| D014947 | Wounds and Injuries |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |