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

NCT06195878 | Recruiting

• 1 other identifier: 23-5716
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (10)

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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)

• 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

• 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

Study Arms (1)

CPAP Therapy

EXPERIMENTAL

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

Interventions

CPAP Therapy DEVICE

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

CPAP Therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University Health Network, Toronto: lead
• Sunnybrook Health Sciences Centre: collaborator

Study Sites (1)

Toronto Rehab - Lyndhurst Centre

Toronto, Ontario, M4G 3V9, Canada

RECRUITING

MeSH Terms

Conditions

Sleep Apnea Syndromes; Sleep Wake Disorders; Spinal Cord Injuries; Spinal Diseases

Condition Hierarchy (Ancestors)

Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Nervous System Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders; Spinal Cord Diseases; Central Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries; Bone Diseases; Musculoskeletal Diseases

Study Officials

• Dr. Julio Furlan

  University Health Network, Toronto

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Abrity Gomes

CONTACT

4165973422; abrity.gomes@uhn.ca

Mitsue Aibe

CONTACT

4165973422; Mitsue.Aibe@uhn.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Julio C Furlan, MD, PhD

Model Details: Device: Continuous positive airway pressure (CPAP) therapy

Study Record Dates

• First Submitted: December 24, 2023
• First Posted: January 8, 2024
• Study Start: February 20, 2024
• Primary Completion: August 1, 2025
• Study Completion: December 1, 2025
• Last Updated: March 26, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)