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Device

CPAP Therapy for Spinal Cord Injury

N/A
Recruiting
Led By Julio C Furlan, MD, FRCPC
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)
Not being treated for sleep apnea prior to the spinal cord impairment onset
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from baseline to 6 months after recruitment
Awards & highlights

Study Summary

This trial will compare the effects of early and delayed CPAP therapy for sleep-related breathing disorders after spinal cord injury.

Who is the study for?
The OPTIMISE SCI trial is for English-speaking adults over 18 with recent (≤30 days old) spinal cord injuries from C2 to T12, either complete or incomplete. It's not for those with non-traumatic spinal diseases, other central nervous system conditions, chronic pre-injury pain, significant psychiatric disorders, neuromuscular diseases, substance misuse issues, epilepsy, vitamin B12 deficiency or known hypersomnia unrelated to sleep-related breathing disorders.Check my eligibility
What is being tested?
This study tests CPAP therapy on adults with spinal cord injury and sleep-related breathing disorders. Participants are divided into three groups: one gets early CPAP treatment at 6 weeks post-injury; another starts CPAP at 22 weeks; the third group doesn't get treatment if their SRBDs are mild or absent.See study design
What are the potential side effects?
CPAP therapy side effects can include discomfort or irritation where the mask touches the face, dry nose or throat, runny nose, sneezing and congestion. Some people might feel claustrophobic wearing the mask and experience trouble falling asleep.

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 wasn't treated for sleep apnea before my spinal cord issue began.
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My spinal cord injury is recent and located between my neck and mid-back.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from baseline to 6 months after recruitment
This trial's timeline: 3 weeks for screening, Varies for treatment, and from baseline to 6 months after recruitment for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in International Standards for Neurological Classification of SCI (ISNCSCI) motor subscore from baseline to 6 months after recruitment
Change in International from baseline to 6 months after recruitment Standards for Neurological Classification of SCI (ISNCSCI) sensory subscore
Change in Spinal Cord Independence Measure (SCIM) - version III - score from baseline to 6 months after recruitment
Secondary outcome measures
Change in Depression, Anxiety & Stress Scales- 21 (DASS-21) score from baseline to 6 months after recruitment
Change in Fatigue Severity Scale (FSS) from baseline to 6 months after recruitment
Change in Medical Outcomes Study Sleep Scale (MOS-SS) from baseline to 6 months after recruitment
+2 more

Trial Design

3Treatment groups
Experimental Treatment
Active Control
Group I: Early-CPAP therapy groupExperimental Treatment1 Intervention
Individuals diagnosed with moderate-to-severe sleep-related breathing disorders (SRBDs) who will start CPAP therapy within the first 6 weeks after SCI.
Group II: Delayed-CPAP therapy groupActive Control1 Intervention
Individuals diagnosed with moderate-to-severe SRBDs who will start on CPAP therapy at the 5th month after SCI.
Group III: Non-CPAP therapy groupActive Control1 Intervention
Individuals who are diagnosed with no or mild SRBD.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Continuous positive airway pressure (CPAP) therapy
2010
N/A
~80

Find a Location

Who is running the clinical trial?

University Health Network, TorontoLead Sponsor
1,464 Previous Clinical Trials
483,535 Total Patients Enrolled
Sunnybrook Health Sciences CentreOTHER
654 Previous Clinical Trials
1,543,231 Total Patients Enrolled
Julio C Furlan, MD, FRCPCPrincipal InvestigatorKITE Research Institute, University Health Network

Media Library

CPAP therapy (Device) Clinical Trial Eligibility Overview. Trial Name: NCT05473689 — N/A
Spinal Cord Injury Research Study Groups: Early-CPAP therapy group, Delayed-CPAP therapy group, Non-CPAP therapy group
Spinal Cord Injury Clinical Trial 2023: CPAP therapy Highlights & Side Effects. Trial Name: NCT05473689 — N/A
CPAP therapy (Device) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05473689 — N/A

Frequently Asked Questions

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

How extensive is the enrollment for this research study?

"Yes, the clinicaltrials.gov portal states that this study is currently recruiting participants for enrollment. Initially posted on August 15th 2022, it was last modified on October 31st of the same year and will require 66 enrollees from a single medical centre."

Answered by AI

What are the objectives of this medical study?

"The primary objective of this trial is to observe the alteration in spinal cord independence, as measured by SCIM-version III scores, from baseline until 6 months after recruitment. Secondary endpoints include tracking changes in fatigue severity (FSS), sleep quality (MOS-SS) and psychological health (PHQ-9). These metrics range from 0 to 100 for FSS and MOS-SS and 0 to 27 for PHQ-9 respectively which indicate varying levels of normalcy or distress."

Answered by AI

Are there any unfilled positions remaining in this experiment?

"Affirmative. Clinicaltrials.gov reveals that recruitment for this clinical trial, which was initially published on August 15th 2022, is currently in progress. 66 participants need to be sourced from 1 medical facility."

Answered by AI
~11 spots leftby Jul 2024