Continuous positive airway pressure (CPAP) therapy for Spinal Cord Injuries

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
KITE Toronto Research Institute, Toronto, Canada
Spinal Cord Injuries+2 More
Continuous positive airway pressure (CPAP) therapy - Device
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This randomized clinical trial will compare three groups of individuals with cervical/thoracic, complete or incomplete spinal cord injury (SCI) that will undergo: (i) early CPAP therapy in the management of moderate-to-severe sleep-related breathing disorders (SRBDs) among adults at 6 weeks after SCI; (ii) delayed CPAP therapy in the management of moderate-to-severe SRBDs among adults at 22 weeks after SCI; and (iii) no treatment as they either have mild or no SRBD.

Eligible Conditions

  • Spine Diseases
  • Spinal Cord Injuries

Treatment Effectiveness

Effectiveness Progress

1 of 3

Other trials for Spinal Cord Injuries

Study Objectives

3 Primary · 5 Secondary · Reporting Duration: From baseline to 6 months after recruitment

Month 6
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 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 Medical Outcomes Study Sleep Scale (MOS-SS) from baseline to 6 months after recruitment
Change in Montreal Cognitive Assessment (MoCA test) score from baseline to 6 months after recruitment
Change in Patient Health Questionnaire (PHQ-9) score from baseline to 6 months after recruitment
Change in Spinal Cord Independence Measure (SCIM) - version III - score from baseline to 6 months after recruitment

Trial Safety

Safety Progress

1 of 3

Other trials for Spinal Cord Injuries

Trial Design

3 Treatment Groups

Non-CPAP therapy group
1 of 3
Delayed-CPAP therapy group
1 of 3
Early-CPAP therapy group
1 of 3
Active Control
Experimental Treatment

66 Total Participants · 3 Treatment Groups

Primary Treatment: Continuous positive airway pressure (CPAP) therapy · No Placebo Group · N/A

Early-CPAP therapy group
Device
Experimental Group · 1 Intervention: Continuous positive airway pressure (CPAP) therapy · Intervention Types: Device
Non-CPAP therapy groupNoIntervention Group · 1 Intervention: Non-CPAP therapy group · Intervention Types:
Delayed-CPAP therapy group
Device
ActiveComparator Group · 1 Intervention: Continuous positive airway pressure (CPAP) therapy · Intervention Types: Device
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Continuous positive airway pressure (CPAP) therapy
2010
N/A
~80

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: from baseline to 6 months after recruitment
Closest Location: KITE Toronto Research Institute · Toronto, Canada
Photo of Toronto 1Photo of Toronto 2Photo of Toronto 3
N/AFirst Recorded Clinical Trial
1 TrialsResearching Spinal Cord Injuries
0 CompletedClinical Trials

Who is running the clinical trial?

University Health Network, TorontoLead Sponsor
1,351 Previous Clinical Trials
471,567 Total Patients Enrolled
14 Trials studying Spinal Cord Injuries
244 Patients Enrolled for Spinal Cord Injuries
Sunnybrook Health Sciences CentreOTHER
588 Previous Clinical Trials
1,467,995 Total Patients Enrolled

Eligibility Criteria

Age 18+ · All Participants · 3 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
You have an English-speaking adult (18 years of age or older) as your patient.
You are not being treated for sleep apnea prior to the spinal cord impairment onset.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.