Clinical trial NCT06195878: Sleep Apnea in Paralympic Ontario-Resident aThletes With Spinal Cord Injury (SPORTS) Study
Official title: Sleep Apnea in Paralympic Ontario-Resident aThletes With Spinal Cord Injury (SPORTS) Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Sleep Apnea
Breathing Disorder During Sleeping
Sleep Disorder
Spinal Cord Injuries
Spine Disease
Keywords: sleep-related breathing disorders
sleep apnea
Spinal Cord Injuries
para-athletes
Spinal Diseases
sports
Lead sponsor: University Health Network, Toronto
Sponsor class: OTHER
Collaborators: name: Sunnybrook Health Sciences Centre
First posted: 2024-01-08
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Device: Continuous positive airway pressure (CPAP) therapy
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Fatigue Severity Scale
timeFrame: Change in Fatigue Severity Scale from baseline to after 4-month period of CPAP therapy
measure: Karolinska Sleepiness Scale
timeFrame: Change in Karolinska Sleepiness Scale from baseline to after 4-month period of CPAP therapy
measure: Medical Outcomes Study Sleep Scale
timeFrame: Change in Medical Outcomes Study Sleep Scale from baseline to after 4-month period of CPAP therapy
measure: Depression, Anxiety & Stress Scales- 21
timeFrame: Change in Depression, Anxiety & Stress Scales- 21 from baseline to after 4-month period of CPAP therapy
measure: Craig Handicap Assessment and Recording Technique
timeFrame: Change in Craig Handicap Assessment and Recording Technique from baseline to after 4-month period of CPAP therapy
measure: SF-36
timeFrame: Change in SF-36 from baseline to after 4-month period of CPAP therapy
measure: Montreal Cognitive Assessment
timeFrame: Change in Montreal Cognitive Assessment (MoCA) score from baseline to after 4-month period of CPAP therapy
measure: Recovery-Stress Questionnaire for Athletes (RESTQ-Sport)
timeFrame: aseline (before CPAP therapy) and follow-up assessment (after completion of the 4-month trial of CPAP therapy)
measure: Acute Recovery and Stress Scale (ARSS)
timeFrame: Change in Acute Recovery and Stress Scale from baseline to after 4-month period of CPAP therapy
measure: Sport Performance Test
timeFrame: Change in Sport Performance Test from baseline to after 4-month period of CPAP therapy
Secondary outcomes:
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Toronto Rehab - Lyndhurst Centre
state: Ontario
Study officials:
affiliation: University Health Network, Toronto
name: Dr. Julio Furlan
role: PRINCIPAL_INVESTIGATOR
References: