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

March 25, 2024 updated by: Julio Furlan, MD, University Health Network, Toronto
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

15

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Canada
    • Ontario
      • Toronto, Ontario, Canada, M4G 3V9
        • Recruiting
        • Toronto Rehab - Lyndhurst Centre
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Karolinska Sleepiness Scale
Time Frame: 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).
Change in Karolinska Sleepiness Scale 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
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
Sport Performance Test
Time Frame: 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.
Change in Sport Performance Test from baseline to after 4-month period of CPAP therapy
Fatigue Severity Scale
Time Frame: 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).
Change in Fatigue Severity 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
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
Time Frame: 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).
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
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
Montreal Cognitive Assessment
Time Frame: 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).
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)
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)
Time Frame: 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).
Change in Acute Recovery and Stress Scale from baseline to after 4-month period of CPAP therapy

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Health Network, Toronto

Collaborators

Sunnybrook Health Sciences Centre

Investigators

  • Principal Investigator: Dr. Julio Furlan, University Health Network, Toronto

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 20, 2024

Primary Completion (Estimated)

August 1, 2025

Study Completion (Estimated)

December 1, 2025

Study Registration Dates

First Submitted

December 24, 2023

First Submitted That Met QC Criteria

December 24, 2023

First Posted (Actual)

January 8, 2024

Study Record Updates

Last Update Posted (Actual)

March 26, 2024

Last Update Submitted That Met QC Criteria

March 25, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 23-5716

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

The UHN REB needs to approve any plan to share data from this study.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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