CPAP Therapy for Spinal Cord Injury

Recruiting in Palo Alto (17 mi)

Overseen by Julio C Furlan, MD, FRCPC

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: University Health Network, Toronto

Disqualifiers: Neuromuscular diseases, Epilepsy, Psychiatric disorders, others

No Placebo Group

Approved in 4 Jurisdictions

Trial Summary

What is the purpose of this trial?

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.

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 data supports the effectiveness of CPAP therapy for spinal cord injury?

Research shows that CPAP therapy can significantly improve breathing issues in people with spinal cord injuries who also have sleep apnea. In one case, a patient with a spinal cord injury and severe sleep apnea experienced a rapid improvement in nighttime breathing and oxygen levels after using CPAP therapy. ^{1 2 3 4 5}

Is CPAP therapy safe for people with spinal cord injuries?

CPAP therapy, used for conditions like sleep apnea, is generally considered safe for people with spinal cord injuries, though adherence to treatment can be challenging. Some studies suggest it can help with breathing issues, but long-term effects and side effects are not well-documented. ^{2 3 4 6 7}

How is CPAP therapy different from other treatments for spinal cord injury?

CPAP therapy is unique for spinal cord injury patients because it provides continuous positive airway pressure to help manage sleep-disordered breathing, which is common in these patients. Unlike other treatments, CPAP directly addresses breathing issues during sleep, improving oxygen levels and reducing symptoms like snoring and daytime sleepiness. ^{1 2 3 6 8}

Research Team

Julio C Furlan, MD, FRCPC

Principal Investigator

KITE Research Institute, University Health Network

Eligibility Criteria

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 am 18 or older and speak English.

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.

Trial Timeline

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

Treatment Details

Interventions

• CPAP therapy (Device)

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.

Participant Groups

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 Canada for the following indications:

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+

Dr. Brad Wouters

University Health Network, Toronto

Chief Medical Officer since 2020

MD from University of Toronto

Dr. Kevin Smith

University Health Network, Toronto

Chief Executive Officer since 2018

Professor at McMaster University and University of Toronto

Sunnybrook Health Sciences Centre

Collaborator

Trials

693

Recruited

1,569,000+

Dr. Rajin Mehta

Sunnybrook Health Sciences Centre

Chief Medical Officer

MD from University of Toronto

Dr. Andrew J. Smith

Sunnybrook Health Sciences Centre

President and CEO since 2017

MD, MSc from University of Toronto; Surgical Oncology Fellowship at Memorial Sloan-Kettering Cancer Center

Findings from Research

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]

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]

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]

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]

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]

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]

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]

References

1. Japan pubmed.ncbi.nlm.nih.gov

[Case of obstructive sleep apnea syndrome exacerbated due to cervical spinal cord injury]. [2013]

2. Netherlands 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. [2021]

3. United States pubmed.ncbi.nlm.nih.gov

Continuous Positive Airway Pressure Use for Obstructive Sleep Apnea in Acute, Traumatic Tetraplegia. [2020]

4. United States 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. [2023]

5. England 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. [2020]

6. United States pubmed.ncbi.nlm.nih.gov

Noninvasive Ventilation and Spinal Cord Injury. [2021]

7. United States pubmed.ncbi.nlm.nih.gov

Long-term treatment of sleep apnea in persons with spinal cord injury. [2019]

8. England pubmed.ncbi.nlm.nih.gov

Treatment of sleep apnoea in spinal cord injured patients. [2004]