Sleep Apnea in Paralympic Ontario-Resident aThletes With Spinal Cord Injury (SPORTS) Study

University Health Network, Toronto

Status: Enrolling

Conditions: Spinal Cord Injuries; Sleep Disorder; Spine Disease; Sleep Apnea; Breathing Disorder During Sleeping

Treatments: Device: CPAP Therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT06195878

23-5716

Details and patient eligibility

About

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.

Full 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.

Enrollment: 15 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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15 participants in 1 patient group

CPAP Therapy

Experimental group

Description:

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.

Treatment:

Device: CPAP Therapy