CPAP Therapy for Sleep Apnea in Spinal Cord Injury

Overseen By Mitsue Aibe, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University Health Network, Toronto

Disqualifiers: Psychiatric disorders, Substance misuse, Epilepsy, 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: 1

Duration: 16 weeks

24 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 for individuals with spinal cord injuries who experience sleep-related breathing problems. CPAP therapy uses a machine to keep the airway open during sleep, potentially improving mood, cognition, and behavior. The trial targets individuals who have had a spinal cord injury for at least two months and are experiencing sleep-related breathing difficulties. As an unphased trial, it provides a unique opportunity to contribute to understanding how CPAP therapy can enhance the quality of life for those with spinal cord injuries.

Do I have to stop taking my current medications for this trial?

The trial protocol does not specify whether you need to stop taking your current medications.

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

Research shows that using a CPAP machine is generally safe for treating sleep apnea. It provides a steady flow of air to keep the airway open during sleep, reducing interruptions.

Some people might experience side effects like a stuffy nose, dry mouth, or skin irritation from the mask. These side effects are usually mild and can often be resolved by adjusting the mask or machine settings. While less information exists about its safety for people with spinal cord injuries, CPAP is commonly used for sleep-related breathing problems.

CPAP has been used successfully for many years and is known for its safety. Those considering this therapy should consult their healthcare provider to discuss any concerns or questions. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about using CPAP therapy for sleep apnea in individuals with spinal cord injury because it offers a personalized approach that could be more effective than standard treatments. Unlike other methods that might involve surgery or medications, CPAP therapy uses an auto-titrating feature to adjust air pressure based on each person's needs. This tailored adjustment can lead to better sleep quality and overall health benefits, making it a promising option for those with spinal cord injuries who struggle with sleep apnea.

What evidence suggests that CPAP therapy might be an effective treatment for sleep apnea in spinal cord injury?

Research has shown that a CPAP machine serves as the primary treatment for moderate-to-severe sleep-related breathing problems. CPAP improves sleep by keeping the airway open, which is crucial for individuals with spinal cord injuries who often experience sleep apnea. This trial will assess the effects of a 4-month CPAP therapy period in individuals with spinal cord injuries. Some reports suggest that the benefits of CPAP might decrease over time due to inconsistent use. Despite this, CPAP remains widely recommended for managing sleep apnea. ^{6 7 8 9 10}

Who Is on the Research Team?

Julio Furlan, MD

Principal Investigator

Toronto Rehabilitation Institute

Are You a Good Fit for This Trial?

This trial is for English-speaking adults over 18 with moderate-to-severe sleep-related breathing disorders due to traumatic spinal cord injury between C5 and T10. Participants must be at least 2 months post-injury, not diagnosed with a sleep disorder before the injury, and show symptoms of SRBDs. Excluded are those with chronic fatigue, non-traumatic SCI, kidney failure, certain diseases like hypothyroidism or epilepsy, severe anemia, substance misuse or preinjury chronic pain.

Inclusion Criteria

It has been over 2 months since my injury.

I show signs or symptoms of sleep-related breathing disorders.

I have a spinal cord injury between C5 and T10 without a pre-existing sleep disorder.

Exclusion Criteria

You have a mental health condition that could make it hard for you to follow the study rules.

You have chronic pain before the injury.

I have a neuromuscular disease.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Diagnosis

Participants undergo an unattended-hospital or home-based sleep study for diagnosis of sleep-related breathing disorders

1 week

1 visit (in-person or home-based)

Treatment

Participants receive CPAP therapy for 4 consecutive months to manage moderate-to-severe sleep-related breathing disorders

16 weeks

Regular home use with potential follow-up visits for CPAP adjustment

Follow-up

Participants are monitored for changes in sleepiness, sleep quality, mood, and cognitive function after CPAP therapy

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Continuous positive airway pressure (CPAP) therapy

Trial Overview

The study tests if CPAP therapy can help improve mental health, thinking skills and behavior in people who have trouble sleeping because of their spinal cord injury. It focuses on those who haven't been treated for sleep problems before their injury.

How Is the Trial Designed?

Group I: CPAP-therapy arm Experimental Treatment 1 Intervention

This single-arm clinical trial will examine the effects of 4-month period CPAP therapy in individuals living with SCI. The CPAP will be adjusted according to the results of the auto-titrating CPAP testing for each participant.

Continuous positive airway pressure (CPAP) therapy is already approved in United States, European Union, Canada for the following indications:

Approved in United States as CPAP Therapy for:

• Obstructive Sleep Apnea
• Sleep-Disordered Breathing
• Respiratory Failure

Approved in European Union as CPAP Therapy for:

• Obstructive Sleep Apnea
• Sleep-Disordered Breathing
• Respiratory Failure

Approved in Canada as CPAP Therapy for:

• Obstructive Sleep Apnea
• Sleep-Disordered Breathing
• Respiratory Failure

Who Is Running the Clinical Trial?

University Health Network, Toronto

Lead Sponsor

Trials

1,555

Recruited

526,000+

The Craig H. Neilsen Foundation

Collaborator

Trials

62

Recruited

3,100+

Published Research Related to This Trial

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]

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]

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]

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 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]

In a study of 178 patients with sleep apnea after acute ischemic stroke, both nasal continuous positive airway pressure (nCPAP) and high-flow nasal cannula (HFNC) significantly reduced rates of pulmonary infection and endotracheal intubation compared to usual care, improving early prognosis.

HFNC was found to be more comfortable than nCPAP, making it a potentially better alternative for patients who struggle with adherence to CPAP therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of ventilation modalities on the early prognosis of patients with poststroke sleep apnea. Li, Z., Pang, M., Zhang, J., 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 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]

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