Sleep ApneaNCT06195878
Sleep Apnea in Paralympic Ontario-Resident aThletes With Spinal Cord Injury (SPORTS) Study
A study testing CPAP Therapy in people with Sleep Apnea and Breathing Disorder During Sleeping, run by University Health Network, Toronto at 1 site in Canada.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sleep Apnea, Breathing Disorder During Sleeping, Sleep Disorder
- What is being tested?
- CPAP Therapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteCanada
- Study dates
- 20 Feb 2024to Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Canada1 site, 1 recruiting
- Recruiting
Toronto Rehab - Lyndhurst Centre
Toronto, Ontario, M4G 3V9
Abrity Gomes, 4165973422 ext. 6285, abrity.gomes@uhn.ca
About this study
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.
Read the 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.
- Conditions
- Sleep Apnea, Breathing Disorder During Sleeping, Sleep Disorder, Spinal Cord Injuries, Spine Disease
- Being tested
- CPAP Therapy
- Keywords
- sleep-related breathing disorders, sleep apnea, Spinal Cord Injuries, para-athletes, Spinal Diseases, sports
- Medical subject headings
- Sleep Apnea Syndromes, Sleep Wake Disorders, Spinal Cord Injuries, Spinal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CPAP TherapyDevice
Continuous positive airway pressure (CPAP) therapy in the management of moderate-to-severe sleep-related breathing disorders (SRBDs)/sleep apnea.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: CPAP Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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).
Measured: 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.
Measured: 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).
Measured: 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)
Measured: 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.
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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.
Measured: Change in Sport Performance Test from baseline to after 4-month period of CPAP therapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jan 2024
- Study start20 Feb 2024
- Primary completionAug 2025 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sleep ApneaStudies of the same condition, open and under way.
- More trials run by University Health Network, TorontoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Device: Continuous positive airway pressure (CPAP) therapy
- Masking
- None (open label)
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Health Network, Toronto
- Sponsor type
- University, hospital or other
- Collaborators
- Sunnybrook Health Sciences Centre
- Responsible party
- Principal investigator, Julio Furlan, MD, University Health Network, Toronto
- Investigators
- Dr. Julio Furlan, Principal investigator, University Health Network, Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06195878
- Sponsor's protocol ID
- 23-5716
- Status last verified
- Mar 2024
- First submitted
- 24 Dec 2023
- Last updated
- 26 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The UHN REB needs to approve any plan to share data from this study.
Study at a glance
From the registry record, last updated by the sponsor on 26 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sleep Apnea in Paralympic Ontario-Resident aThletes With Spinal Cord Injury (SPORTS) Study
- ClinicalTrials.gov ID
- NCT06195878
- Acronym / sponsor ID
- 23-5716
- 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
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- University Health Network, TorontoUniversity, hospital or other
- Collaborators
- Sunnybrook Health Sciences Centre
- Study start
- 20 Feb 2024 (actual)
- Primary completion
- Aug 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 8 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Device: Continuous positive airway pressure (CPAP) therapy
| Arm | Type | Receives |
|---|---|---|
| CPAP Therapy | Experimental | Device: CPAP TherapyParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CPAP TherapyContinuous positive airway pressure (CPAP) therapy in the management of moderate-to-severe sleep-related breathing disorders (SRBDs)/sleep apnea. | Device | CPAP Therapy |
Primary outcome
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).
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).
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.
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).
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)
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.
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).
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).
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).
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Mar 2024.
- Individual participant dataSharing planned: No. The UHN REB needs to approve any plan to share data from this study.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dr. Julio Furlan principal investigator
University Health Network, Toronto
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CPAP Therapy in people with Sleep Apnea and Breathing Disorder During Sleeping, run by University Health Network, Toronto at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 26 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Abrity Gomes (4165973422 ext. 6285, abrity.gomes@uhn.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fatigue Severity Scale (time frame: Change in Fatigue Severity Scale from baseline to after 4-month period of CPAP therapy). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Mar 2024.