An interventional study of CPAP Therapy in Sleep Apnea, Breathing Disorder During Sleeping and Sleep Disorder, 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 2024-03-26.
Sponsored by University Health Network, Toronto · Not applicable, Interventional, and Treatment
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.
1,084 studies on the registry are indexed under Sleep Apnea Syndromes; 171 are open to participants now.
This study's planned enrollment of 15 is below the median of 60 across 673 interventional studies indexed under Sleep Apnea Syndromes.
Browse Sleep Apnea Syndromes 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:
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.
Device: CPAP Therapy
Continuous positive airway pressure (CPAP) therapy in the management of moderate-to-severe sleep-related breathing disorders (SRBDs)/sleep apnea.
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).
Time frame: 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).
Time frame: 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.
Time frame: 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).
Time frame: 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)
Time frame: Change in Craig Handicap Assessment and Recording Technique from baseline to after 4-month period of CPAP therapy
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.
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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.
Time frame: Change in Sport Performance Test from baseline to after 4-month period of CPAP therapy
Plan to share: No — The UHN REB needs to approve any plan to share data from this study.
No publications or documents are linked to this record.
Started Feb 2024 (actual). Primary completion is estimated for Aug 2025, 18 months after the start.
Of 200 non-industry interventional studies with no phase under Sleep Apnea Syndromes, half reached primary completion within 42 months of starting (the median), counting those still running; a quarter within 15 and three quarters within 60. This study's planned 18 months is below that.
Counting every sponsor, half of 268 studies reached it within 26 months; a quarter within 11 and three quarters within 56.
How these figures are worked out, and which studies are left out of them.
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