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CPAP Therapy for Sleep Apnea in Spinal Cord Injury

N/A

Recruiting

Led By Julio Furlan, MD

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

English-speaking adults 18 years of age or older

Have traumatic cervical/thoracic (injury level at C5 to T10), severe or moderate (AIS A, B, or C) SCI who were not diagnosed with a sleep disorder prior to the injury

Must not have

Neuromuscular diseases

Concomitant diseases of the central nervous system

Timeline

Screening 3 weeks

Treatment Varies

Follow Up change in depression, anxiety & stress scales- 21 from baseline to after 4-month period of cpap therapy

Awards & highlights

No Placebo-Only Group

Summary

This trial will test if CPAP therapy can help improve mental health, thinking, and behavior problems caused by moderate to severe sleep-related breathing disorders in people with spinal cord injury.

Who is the study for?

This trial is for English-speaking adults over 18 with moderate-to-severe sleep-related breathing disorders due to traumatic spinal cord injury between C5 and T10. Participants must be at least 2 months post-injury, not diagnosed with a sleep disorder before the injury, and show symptoms of SRBDs. Excluded are those with chronic fatigue, non-traumatic SCI, kidney failure, certain diseases like hypothyroidism or epilepsy, severe anemia, substance misuse or preinjury chronic pain.

What is being tested?

The study tests if CPAP therapy can help improve mental health, thinking skills and behavior in people who have trouble sleeping because of their spinal cord injury. It focuses on those who haven't been treated for sleep problems before their injury.

What are the potential side effects?

CPAP therapy may cause discomfort such as nasal congestion or dryness, mask discomfort or air leaks around the mask. Some might feel claustrophobic or experience chest muscle discomfort.

Eligibility Criteria

Inclusion Criteria

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

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I am 18 or older and speak English.

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I have a spinal cord injury between C5 and T10 without a pre-existing sleep disorder.

Exclusion Criteria

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

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I have a neuromuscular disease.

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I have a brain or spinal cord disease.

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I have epilepsy.

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I have kidney failure.

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I have been diagnosed with chronic fatigue syndrome.

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I have a spinal condition that could get worse.

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I currently have an infection.

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I have been diagnosed with primary hypersomnia.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ change in depression, anxiety & stress scales- 21 from baseline to after 4-month period of cpap therapy

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~change in depression, anxiety & stress scales- 21 from baseline to after 4-month period of cpap therapy

This trial's timeline: 3 weeks for screening, Varies for treatment, and change in depression, anxiety & stress scales- 21 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

Fatigue Severity Scale

Secondary study objectives

Depression, Anxiety & Stress Scales- 21

Epworth Sleepiness Score

Medical Outcomes Study Sleep Scale

+1 more

Other study objectives

Face-to-face, 1-hour interview for qualitative analysis

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-therapy armExperimental Treatment1 Intervention

This single-arm clinical trial will examine the effects of 4-month period CPAP therapy in individuals living with SCI. The CPAP will be adjusted according to the results of the auto-titrating CPAP testing for each participant.

0 / 10Eligibility criteria met