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

Not Applicable

Recruiting

• Conditions: Sleep Apnea; Spinal Cord Injuries; Spine Disease; Breathing Disorder During Sleeping; Sleep Disorder
• Interventions: Device: CPAP Therapy

• Registration Number: NCT06195878
• Lead Sponsor: University Health Network, Toronto

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.

Study Timeline

• Study First Submitted: 2023-12-24
• Study First Submitted QC: 2023-12-24
• Study First Posted: 2024-01-08
• Study Start: 2024-02-20
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-25
• Last Update Posted: 2024-03-26
• Primary Completion: 2025-08
• Study Completion: 2025-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 15

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
CPAP Therapy	CPAP Therapy	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.

Primary Outcome Measures

Name	Time	Method
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).
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.
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).
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).
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)
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).
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).
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.

Trial Locations

Locations (1)

Toronto Rehab - Lyndhurst Centre; 🇨🇦 Toronto, Ontario, Canada