CPAP Therapy for Spinal Cord Injury

Overseen By Lamisa Etu, BSc

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University Health Network, Toronto

Disqualifiers: Neuromuscular diseases, Epilepsy, Psychiatric disorders, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 4 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

66 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines the effectiveness of CPAP therapy (a machine that aids breathing during sleep) for individuals with spinal cord injuries who experience sleep-related breathing issues. Participants will be divided into three groups: one will start CPAP therapy early, another will start it later, and a third group will not receive the therapy if their condition is mild or non-existent. Individuals who have sustained a spinal cord injury in the neck or upper back within the last month and have not received treatment for sleep apnea before their injury may be suitable candidates. As an unphased trial, this study provides participants the chance to contribute to valuable research that could enhance future treatment options for others with similar conditions.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that CPAP therapy is safe for individuals with spinal cord injury?

Research has shown that CPAP therapy, or continuous positive airway pressure, is generally safe and serves as the main treatment for moderate-to-severe sleep-related breathing problems. Studies have found that most people, including those with spinal cord injuries, can use it without issues. However, some individuals might find it uncomfortable and struggle with consistent use. Reports of minor side effects, such as dryness in the nose or throat, are common but usually manageable. CPAP therapy is widely used and trusted, with a strong safety record for treating sleep problems. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about using CPAP therapy for individuals with spinal cord injuries (SCI) because it specifically targets sleep-related breathing disorders (SRBDs) that are commonly overlooked in this population. Unlike standard treatments that may focus solely on the physical rehabilitation of SCI, CPAP therapy addresses the breathing difficulties that can significantly impact sleep quality and overall recovery. The trial is exploring the effectiveness of starting CPAP therapy early, within six weeks of SCI, compared to a delayed start at five months, aiming to determine the optimal timing for improving sleep and potentially enhancing recovery outcomes. This approach could lead to more comprehensive care strategies for SCI patients by integrating respiratory management early in the treatment process.

What evidence suggests that CPAP therapy is effective for sleep-related breathing disorders in spinal cord injury patients?

This trial will compare different timing strategies for CPAP therapy in individuals with spinal cord injuries. Studies have shown that CPAP, or continuous positive airway pressure, is the best treatment for moderate-to-severe sleep-related breathing problems. It keeps the airway open during sleep, which is especially beneficial for people with spinal cord injuries who often have sleep apnea. CPAP can improve sleep quality and reduce symptoms. However, some research suggests its effectiveness might decrease over time if not used regularly. Despite this, CPAP remains crucial for managing sleep issues in this group. ^{2 3 4 5 6}

Who Is on the Research Team?

Julio C Furlan, MD, FRCPC

Principal Investigator

KITE Research Institute, University Health Network

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

I wasn't treated for sleep apnea before my spinal cord issue began.

My spinal cord injury is recent and located between my neck and mid-back.

Exclusion Criteria

I have epilepsy.

Preinjury chronic pain

I have a spinal cord condition like MS that could get worse.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Early CPAP Therapy

Participants with moderate-to-severe SRBDs start CPAP therapy within the first 6 weeks after SCI

6 weeks

Delayed CPAP Therapy

Participants with moderate-to-severe SRBDs start CPAP therapy at the 5th month after SCI

4 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

6 months

What Are the Treatments Tested in This Trial?

Interventions

• CPAP therapy

Trial Overview 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.

How Is the Trial Designed?

Group I: Early-CPAP therapy group Experimental Treatment 1 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 group Active Control 1 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 group Active Control 1 Intervention

Individuals who are diagnosed with no or mild SRBD.

CPAP therapy is already approved in European Union, United States, Canada for the following indications:

Approved in European Union as CPAP Therapy for:

• Obstructive Sleep Apnea
• Sleep-Related Breathing Disorders

Approved in United States as CPAP Therapy for:

• Obstructive Sleep Apnea
• Central Sleep Apnea
• Sleep-Related Breathing Disorders

Approved in Canada as CPAP Therapy for:

• Obstructive Sleep Apnea
• Sleep-Related Breathing Disorders

Who Is Running the Clinical Trial?

University Health Network, Toronto

Lead Sponsor

Trials

1,555

Recruited

526,000+

Sunnybrook Health Sciences Centre

Collaborator

Trials

693

Recruited

1,569,000+

Published Research Related to This Trial

In a study of 79 individuals with acute tetraplegia and obstructive sleep apnea, only 33% adhered to CPAP therapy, averaging 2.9 hours of use per night over 3 months, indicating low adherence rates in this population.

Adherence to CPAP was better in patients with more severe obstructive sleep apnea and those who used the device more in the first week, suggesting that early acceptance of therapy is crucial for improving long-term use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Continuous Positive Airway Pressure Use for Obstructive Sleep Apnea in Acute, Traumatic Tetraplegia. Graco, M., Schembri, R., Ross, J., et al.[2020]

A study involving 17 individuals with spinal cord injury (SCI) revealed that adherence to CPAP therapy for sleep apnea is influenced by unique factors such as physical dependence on caregivers and the increased burden of daily care, which are not typically seen in the general population.

The research identified four key categories affecting adherence: the process of diagnosing sleep apnea, fitting the CPAP device, perceptions of sleep apnea, and actual adherence levels, highlighting the need for tailored approaches in managing sleep apnea in individuals with SCI.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Factors influencing adherence to continuous positive airway pressure devices in individuals with spinal cord injury and sleep apnea: Results of a qualitative study. Bulteel, C., Le Bonniec, A., Gounelle, M., et al.[2021]

High-flow nasal cannula (HFNC) oxygen therapy effectively improved swallowing function in an 87-year-old man with dysphagia following a cervical spinal cord injury, demonstrating its potential as a treatment for dysphagia related to respiratory muscle paralysis.

The therapy not only enhanced swallowing capabilities but also helped prevent complications like aspiration pneumonia, suggesting that HFNC may support both swallowing and respiratory functions in patients with similar conditions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

High-flow nasal cannula oxygen therapy was effective for dysphagia associated with respiratory muscle paralysis due to cervical spinal cord injury: A case report. Watanabe, Y., Tamura, T., Imai, R., et al.[2023]

A 70-year-old man with quadriplegia due to a cervical spinal cord injury was found to have severe obstructive sleep apnea (OSA) with an apnea-hypopnea index of 46.5/hr, indicating a significant respiratory issue exacerbated by his injury.

Treatment with nasal continuous positive airway pressure (NCPAP) led to a dramatic improvement in his condition, reducing the oxygen desaturation index from 31.0 dips/hr to 0 dips/hr over 60 days, demonstrating the efficacy of NCPAP in managing OSA in this patient.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Case of obstructive sleep apnea syndrome exacerbated due to cervical spinal cord injury]. Nagaoka, H., Kitagawa, K., Kishi, K., et al.[2013]

In a study of 16 individuals with tetraplegia and obstructive sleep apnoea, only 38% adhered to CPAP therapy after one month, with adherence dropping to 25% by six and twelve months, indicating significant challenges in long-term use.

Participants reported discomfort and emotional issues as barriers to CPAP use, while those who adhered noted improvements in mood and alertness, suggesting that more intensive and prolonged support is needed to help them manage the burdens of CPAP therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Worth the effort? Weighing up the benefit and burden of continuous positive airway pressure therapy for the treatment of obstructive sleep apnoea in chronic tetraplegia. Graco, M., Green, SE., Tolson, J., et al.[2020]

In a study of three spinal cord injured patients with severe daytime sleepiness, two were found to have sleep apnea and benefited from treatment with continuous positive airway pressure, improving their sleep quality and oxygen levels.

One obese patient improved his sleep issues by following lifestyle changes, such as losing weight and reducing smoking and alcohol, highlighting the importance of tailored advice for managing sleep disorders in SCI patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Treatment of sleep apnoea in spinal cord injured patients. Biering-Sørensen, M., Norup, PW., Jacobsen, E., et al.[2004]

Individuals with spinal cord injury (SCI) are at a higher risk for sleep-disordered breathing (SDB), which requires personalized management strategies due to its connection with respiratory control issues, especially in cervical SCI.

Noninvasive ventilation, particularly positive airway pressure treatment, can effectively reduce SDB and improve symptoms of sleepiness, but many patients struggle with adherence to this treatment, raising concerns about its long-term effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Noninvasive Ventilation and Spinal Cord Injury. Daoud, A., Haider, S., Sankari, A.[2021]

A survey of 40 individuals with spinal cord injury and sleep apnea revealed that 80% tried continuous positive airway pressure (CPAP) therapy, with 63% continuing its use regularly, averaging 6.5 nights and 6.9 hours per week.

Participants reported that CPAP was beneficial despite some side effects, such as nasal congestion and mask discomfort, indicating that it can be an effective long-term treatment for sleep apnea in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Long-term treatment of sleep apnea in persons with spinal cord injury. Burns, SP., Rad, MY., Bryant, S., et al.[2019]

Citations

1. clinicaltrials.gov clinicaltrials.gov/ct2/show/NCT05473689

Outcomes Post Treatment: Impact on Motor Impairment of ... This randomized clinical trial will compare three groups of individuals with cervical/thoracic, complete or incomplete spinal cord injury (SCI) that will ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12161322/

Impact on Motor Impairment of Sleep Efficiency in Spinal Cord ... Continuous positive airway pressure (CPAP) therapy is the current treatment of choice for moderate-to-severe SRBDs. CPAP therapy has been shown ...

3. sciencedirect.com sciencedirect.com/science/article/pii/S1877065719301009

Factors influencing adherence to continuous positive ... In individuals with spinal cord injury (SCI) and sleep apnea (SA), adherence to continuous positive airway pressure (CPAP) therapy seems unsatisfactory despite ...

4. jcsm.aasm.org jcsm.aasm.org/doi/10.5664/jcsm.11752

Sleep apnea in individuals with spinal cord injury SDB is extremely common in individuals with SCI. The efficacy of PAP therapy is suboptimal, and adherence rates decline significantly over time.

5. academic.oup.com academic.oup.com/sleep/article/47/5/zsae068/7624023

Not there yet; the challenge of treating sleep-disordered ... Intensive support does not improve positive-airway pressure use in spinal cord injury/disease: a randomized clinical trial. Citing articles ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6467247/

Positive airway pressure for sleep-disordered breathing in ... Untreated, incident SDB is highly likely to adversely impact on learning and skill acquisition during rehabilitation after cervical cord injury.