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

Spinal Cord Injuries Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06195878
• Other study ID #: 23-5716
• Status: Recruiting
• Phase: N/A
• Start date: February 20, 2024
• Est. completion date: December 2025

Study information

• Verified date: March 2024
• Source: University Health Network, Toronto
• Contact: Abrity Gomes
• Phone: 4165973422
• Email: abrity.gomes[@]uhn.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 15
• Est. completion date: December 2025
• Est. primary completion date: August 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Apnea
• Respiratory Aspiration
• Sleep Apnea
• Sleep Apnea Syndromes
• Sleep Disorder
• Sleep Wake Disorders
• Spinal Cord Injuries
• Spinal Diseases
• Spine Disease
• Wounds and Injuries

Intervention

Device:
• CPAP Therapy
Continuous positive airway pressure (CPAP) therapy in the management of moderate-to-severe sleep-related breathing disorders (SRBDs)/sleep apnea.

Locations

Country	Name	City	State
Canada	Toronto Rehab - Lyndhurst Centre	Toronto	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
University Health Network, Toronto	Sunnybrook Health Sciences Centre

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).	Change in Fatigue Severity Scale from baseline to after 4-month period of CPAP therapy
Primary	Karolinska Sleepiness Scale	Measure the level of daytime sleepiness. The scores vary from 1 (normal) to 10 (extremely sleepy).	Change in Karolinska Sleepiness Scale from baseline to after 4-month period of CPAP therapy
Primary	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.	Change in Medical Outcomes Study Sleep Scale from baseline to after 4-month period of CPAP therapy
Primary	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).	Change in Depression, Anxiety & Stress Scales- 21 from baseline to after 4-month period of CPAP therapy
Primary	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)	Change in Craig Handicap Assessment and Recording Technique from baseline to after 4-month period of CPAP therapy
Primary	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.	Change in SF-36 from baseline to after 4-month period of CPAP therapy
Primary	Montreal Cognitive Assessment	The Montreal Cognitive Assessment test assess cognitive impairment and scores vary from 0 (worst outcome) to 30 (best outcome).	Change in Montreal Cognitive Assessment (MoCA) score from baseline to after 4-month period of CPAP therapy
Primary	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).	aseline (before CPAP therapy) and follow-up assessment (after completion of the 4-month trial of CPAP therapy)
Primary	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).	Change in Acute Recovery and Stress Scale from baseline to after 4-month period of CPAP therapy
Primary	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.	Change in Sport Performance Test from baseline to after 4-month period of CPAP therapy