Sleep Apnea, Breathing Disorder During Sleeping, Sleep Disorder, Spinal Cord Injuries, Spine Disease
Conditions
Keywords
sleep-related breathing disorders, sleep apnea, Spinal Cord Injuries, para-athletes, Spinal Diseases, sports
Brief summary
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.
Detailed description
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.
Interventions
DEVICECPAP Therapy
Continuous positive airway pressure (CPAP) therapy in the management of moderate-to-severe sleep-related breathing disorders (SRBDs)/sleep apnea.
Sponsors
Sunnybrook Health Sciences Centre
University Health Network, Toronto
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Device: Continuous positive airway pressure (CPAP) therapy
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Fatigue Severity Scale | Change in Fatigue Severity Scale from baseline to after 4-month period of CPAP therapy | 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). |
| Karolinska Sleepiness Scale | Change in Karolinska Sleepiness Scale from baseline to after 4-month period of CPAP therapy | Measure the level of daytime sleepiness. The scores vary from 1 (normal) to 10 (extremely sleepy). |
| Medical Outcomes Study Sleep Scale | Change in Medical Outcomes Study Sleep Scale from baseline to after 4-month period of CPAP therapy | Scores for the sleep disturbance, snoring, respiratory problems, sleep adequacy, and daytime somnolence dimensions range from 0 (normal) to 100. |
| Depression, Anxiety & Stress Scales- 21 | Change in Depression, Anxiety & Stress Scales- 21 from baseline to after 4-month period of CPAP therapy | 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). |
| Craig Handicap Assessment and Recording Technique | Change in Craig Handicap Assessment and Recording Technique from baseline to after 4-month period of CPAP therapy | 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) |
| SF-36 | Change in SF-36 from baseline to after 4-month period of CPAP therapy | 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. |
| Montreal Cognitive Assessment | Change in Montreal Cognitive Assessment (MoCA) score from baseline to after 4-month period of CPAP therapy | The Montreal Cognitive Assessment test assess cognitive impairment and scores vary from 0 (worst outcome) to 30 (best outcome). |
| Recovery-Stress Questionnaire for Athletes (RESTQ-Sport) | aseline (before CPAP therapy) and follow-up assessment (after completion of the 4-month trial of CPAP therapy) | 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). |
| Acute Recovery and Stress Scale (ARSS) | Change in Acute Recovery and Stress Scale from baseline to after 4-month period of CPAP therapy | 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). |
| Sport Performance Test | Change in Sport Performance Test from baseline to after 4-month period of CPAP therapy | 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. |
Countries
Canada
Contacts
Primary ContactAbrity Gomes
Backup ContactMitsue Aibe
Outcome results
None listed