Recruiting

Observational Study

Sponsor:

University Health Network, Toronto

Code:

NCT06195878

Conditions

Sleep Apnea

Breathing Disorder During Sleeping

Sleep Disorder

Spinal Cord Injuries

Spine Disease

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

CPAP Therapy

Study Details

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

Study ID

NCT06195878

Start date

Feb 20, 2024

Status verified date

Mar, 2024

Completion date

Dec, 2025

Anticipated

Primary completion date

Aug, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

15 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: 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.

Interventions

CPAP Therapy

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

Primary outcome measure

  • Fatigue Severity Scale [ Time Frame: Change in Fatigue Severity Scale from baseline to after 4-month period of CPAP therapy ]
  • Karolinska Sleepiness Scale [ Time Frame: Change in Karolinska Sleepiness Scale from baseline to after 4-month period of CPAP therapy ]
  • Medical Outcomes Study Sleep Scale [ Time Frame: Change in Medical Outcomes Study Sleep Scale from baseline to after 4-month period of CPAP therapy ]
  • Depression, Anxiety & Stress Scales- 21 [ Time Frame: Change in Depression, Anxiety & Stress Scales- 21 from baseline to after 4-month period of CPAP therapy ]
  • Craig Handicap Assessment and Recording Technique [ Time Frame: Change in Craig Handicap Assessment and Recording Technique from baseline to after 4-month period of CPAP therapy ]
  • SF-36 [ Time Frame: Change in SF-36 from baseline to after 4-month period of CPAP therapy ]
  • Montreal Cognitive Assessment [ Time Frame: Change in Montreal Cognitive Assessment (MoCA) score from baseline to after 4-month period of CPAP therapy ]
  • Recovery-Stress Questionnaire for Athletes (RESTQ-Sport) [ Time Frame: aseline (before CPAP therapy) and follow-up assessment (after completion of the 4-month trial of CPAP therapy) ]
  • Acute Recovery and Stress Scale (ARSS) [ Time Frame: Change in Acute Recovery and Stress Scale from baseline to after 4-month period of CPAP therapy ]
  • Sport Performance Test [ Time Frame: Change in Sport Performance Test from baseline to after 4-month period of CPAP therapy ]

Central Contacts and Locations

Central contacts

Abrity Gomes

4165973422abrity.gomes@uhn.ca

Mitsue Aibe

4165973422Mitsue.Aibe@uhn.ca

Locations

Toronto Rehab - Lyndhurst Centre

Recruiting

Toronto, Ontario, Canada, M4G 3V9

Contacts

Abrity Gomes

4165973422abrity.gomes@uhn.ca

More Information

Sponsor

University Health Network, Toronto

Last update posted

Mar 26, 2024

Last verified

Mar, 2024

Keywords

  • sleep-related breathing disorders
  • sleep apnea
  • Spinal Cord Injuries
  • para-athletes
  • Spinal Diseases
  • sports

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University Health Network, Toronto on 2024-03-26.