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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
At least 2 months after injury
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

Study 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.Check my eligibility
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.See study design
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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It has been over 2 months since my injury.
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I show signs or symptoms of sleep-related breathing disorders.
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I have a spinal cord injury between C5 and T10 without a pre-existing sleep disorder.

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
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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Fatigue Severity Scale
Secondary outcome measures
Depression, Anxiety & Stress Scales- 21
Epworth Sleepiness Score
Medical Outcomes Study Sleep Scale
+1 more
Other outcome measures
Face-to-face, 1-hour interview for qualitative analysis

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.

Find a Location

Who is running the clinical trial?

University Health Network, TorontoLead Sponsor
1,463 Previous Clinical Trials
483,507 Total Patients Enrolled
4 Trials studying Sleep Apnea
355 Patients Enrolled for Sleep Apnea
The Craig H. Neilsen FoundationOTHER
54 Previous Clinical Trials
2,871 Total Patients Enrolled
Julio Furlan, MDPrincipal InvestigatorToronto Rehabilitation Institute
1 Previous Clinical Trials
60 Total Patients Enrolled
1 Trials studying Sleep Apnea
60 Patients Enrolled for Sleep Apnea

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the cap on participants in this experiment?

"Affirmative. According to the data hosted on clinicaltrials.gov, this medical trial is still recruiting participants since it was first posted in September of 2019 and last updated in August 2022. 24 individuals are needed across one site for successful enrollment into the study."

Answered by AI

Is this experiment actively seeking participants?

"That is correct. According to the records from clinicaltrials.gov, this trial initiated on September 27th 2019 and was recently updated on August 16th 2022. The experiment requires 24 total participants at a single site for completion."

Answered by AI
~0 spots leftby Apr 2024