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Procedure

CPAP Therapy for Sleep Apnea

N/A

Recruiting

Led By Dr. Julio Furlan

Research Sponsored by University Health Network, Toronto

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

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)

Must not have

Concomitant diseases of the central nervous system and other pre-existing diseases of the central nervous system

History of primary hypersomnia, or secondary hypersomnia of any cause except for SRBDs

Timeline

Screening 3 weeks

Treatment Varies

Follow Up change in sf-36 from baseline to after 4-month period of cpap therapy

Awards & highlights

No Placebo-Only Group

Summary

This trial will investigate if continuous positive airway pressure (CPAP) therapy can help improve cognitive function and overall quality of life for para-athletes with spinal cord injuries and sleep-related breathing disorders.

Who is the study for?

This trial is for para-athletes in Ontario with spinal cord injuries who have moderate-to-severe sleep-related breathing disorders. Participants should be experiencing issues like cognitive impairment, fatigue, depression, or anxiety and are looking to improve their quality of life and sports performance.

What is being tested?

The study is testing if CPAP therapy can help these athletes by improving mental sharpness, reducing tiredness and negative feelings, enhancing overall well-being, and lowering the chance of sports injuries.

What are the potential side effects?

CPAP therapy may cause side effects such as discomfort or irritation where the mask touches the face, dry nose or throat, headaches, excessive dreaming during early use, stomach bloating and leaks around the mask.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have had a spinal cord injury in my neck or upper back for more than 6 months.

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I am 18 or older and speak English.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have no brain or nervous system diseases.

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I have a history of severe daytime sleepiness not caused by sleep-related breathing disorders.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ change in sf-36 from baseline to after 4-month period of cpap therapy

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~change in sf-36 from baseline to after 4-month period of cpap therapy

This trial's timeline: 3 weeks for screening, Varies for treatment, and change in sf-36 from baseline to after 4-month period of cpap therapy for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Acute Recovery and Stress Scale (ARSS)

Craig Handicap Assessment and Recording Technique

Depression, Anxiety & Stress Scales- 21

+7 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: CPAP TherapyExperimental Treatment1 Intervention

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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

CPAP Therapy

2008

N/A

~160

0 / 4Eligibility criteria met