What side effects are associated with this type of intervention?

Common treatments for Spinal Cord Injury (SCI) include pharmacologic agents, physical therapy, and respiratory management such as CPAP therapy. CPAP therapy, used to manage sleep-related breathing disorders in SCI patients, can have side effects including nasal congestion, dry mouth, skin irritation from the mask, and discomfort. Pharmacologic treatments may cause side effects like dizziness, gastrointestinal issues, and potential dependency. Physical therapy, while generally safe, can sometimes lead to muscle soreness or fatigue. Overall, the side effects vary depending on the specific treatment modality used.

What prior FDA approvals exist?

There is no specific mention of FDA-approved treatments for Spinal Cord Injury (SCI) in the provided context. However, CPAP therapy is being studied for its potential benefits in managing sleep-related breathing disorders in SCI patients. CPAP therapy is commonly used to keep airways open during sleep, which can be crucial for individuals with SCI who may experience respiratory complications. While the context does not provide details on FDA approvals for SCI treatments, it highlights ongoing research into therapies that could improve respiratory function and overall quality of life for these patients.

What other types of research exist?

Promising novel alternatives to CPAP therapy for spinal cord injury patients include non-invasive positive pressure ventilation (NIPPV), mechanical insufflation-exsufflation (MI-E) devices, and diaphragm pacing. These methods have shown efficacy in managing respiratory insufficiency and improving patient outcomes.

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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

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from baseline to 6 months after recruitment

Awards & highlights

No Placebo-Only Group

Summary

This trial will test if using a CPAP machine can help adults with spinal cord injuries who have serious sleep breathing problems. The machine helps them breathe better by keeping their airways open while they sleep.

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.

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.

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.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from baseline to 6 months after recruitment

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

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

Primary study objectives

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 study objectives

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

Awards & Highlights

No Placebo-Only Group

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

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

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Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for Spinal Cord Injury (SCI) focus on managing respiratory complications due to impaired respiratory muscle function and reduced lung volumes. CPAP therapy, for instance, provides continuous positive airway pressure to keep airways open during sleep, preventing airway collapse and improving oxygenation. This is crucial for SCI patients who often have weakened respiratory muscles and compromised ventilatory control. Other treatments like noninvasive positive pressure ventilation (NPPV) and mechanical insufflation-exsufflation help maintain adequate ventilation and clear secretions, reducing the risk of pneumonia and other pulmonary issues. These interventions are essential for enhancing respiratory function and overall quality of life in SCI patients.

Effects of Respiratory Muscle Training on Baroreflex Sensitivity, Respiratory Function, and Serum Oxidative Stress in Acute Cervical Spinal Cord Injury.Impact of cervical spinal cord contusion on the breathing pattern across the sleep-wake cycle in the rat.The immediate effects of breathing with oscillated inspiratory and expiratory airflows on secretion clearance in intubated patients with cervical spinal cord injury.