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

NCT ID: NCT06195878

Last Updated: 2024-03-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

15 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-02-20

Study Completion Date

2025-12-31

Brief Summary

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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

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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

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Sleep Apnea Breathing Disorder During Sleeping Sleep Disorder Spinal Cord Injuries Spine Disease

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Device: Continuous positive airway pressure (CPAP) therapy
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

CPAP Therapy

Intervention Type DEVICE

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

Interventions

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CPAP Therapy

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

Intervention Type DEVICE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Sunnybrook Health Sciences Centre

OTHER

Sponsor Role collaborator

University Health Network, Toronto

OTHER

Sponsor Role lead

Responsible Party

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Julio Furlan, MD

Julio C Furlan, MD, PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Dr. Julio Furlan

Role: PRINCIPAL_INVESTIGATOR

University Health Network, Toronto

Locations

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Toronto Rehab - Lyndhurst Centre

Toronto, Ontario, Canada

Site Status RECRUITING

Countries

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Canada

Central Contacts

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Abrity Gomes

Role: CONTACT

4165973422 ext. 6285

Mitsue Aibe

Role: CONTACT

4165973422 ext. 6285

Facility Contacts

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Abrity Gomes

Role: primary

4165973422 ext. 6285

Other Identifiers

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23-5716

Identifier Type: -

Identifier Source: org_study_id

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