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.
Is CPAP therapy a promising treatment for spinal cord injury?CPAP therapy can be a promising treatment for people with spinal cord injuries who have sleep-related breathing problems. It has shown good results in improving sleep quality and reducing breathing issues during sleep, leading to better oxygen levels and less daytime sleepiness.13567
What safety data exists for CPAP therapy in spinal cord injury patients?The safety data for CPAP therapy in spinal cord injury patients is limited. Studies indicate that while CPAP can be effective in managing sleep-disordered breathing and improving symptoms, adherence to treatment is often poor. There is also limited information on long-term outcomes and side effects, although noninvasive ventilation, including CPAP, is considered important for managing respiratory complications in these patients.25678
What data supports the idea that CPAP Therapy for Spinal Cord Injury is an effective treatment?The available research shows that CPAP therapy can be effective for people with spinal cord injuries who also have sleep apnea. In one case, a 70-year-old man with a spinal cord injury experienced severe sleep apnea symptoms, which improved significantly after using CPAP therapy. His nighttime breathing issues and snoring disappeared quickly, and his oxygen levels during sleep improved dramatically over 60 days. This suggests that CPAP therapy can help improve breathing and oxygen levels in people with spinal cord injuries.34568
Do I have to stop taking my current medications for the trial?The trial protocol does not specify if you need to stop taking your current medications. However, if you have any of the listed exclusion conditions, you may not be eligible to participate.
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.Treatment Details
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.
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.
CPAP therapy is already approved in European Union, United States, Canada, Australia 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
🇦🇺 Approved in Australia as CPAP Therapy for:
- Obstructive Sleep Apnea
- Sleep-Related Breathing Disorders
Find a clinic near you
Research locations nearbySelect from list below to view details:
KITE Toronto Research InstituteToronto, Canada
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Who is running the clinical trial?
University Health Network, TorontoLead Sponsor
Sunnybrook Health Sciences CentreCollaborator
References
Treatment of sleep apnoea in spinal cord injured patients. [2004]Little is known about sleep disorders in spinal cord injured (SCI) patients. Three SCI patients who reported severe daytime sleepiness and sleep complaints were evaluated with nocturnal polysomnography and oxygen saturation with pulsoximeter on several occasions at home. In addition respiratory registration was preformed during overnight stay in the hospital. Two patients who had sleep apnoea episodes with reduced oxygen saturation during sleep were treated with continuous positive airway pressure with good results on sleep architecture, oxygen saturation, and daytime sleepiness. One obese patient was advised to lose weight and to reduce smoking and alcohol consumption, and following this advice his sleep related problems were reduced with no further treatment necessary. It is suggested that SCI patients who complain about sleep related disorders should be appropriately screened, with inclusion of nocturnal polysomnography, oxygen saturation, and respiratory registration and, depending on the screening results, appropriate advice/treatment applied.
Long-term treatment of sleep apnea in persons with spinal cord injury. [2019]Although numerous studies have documented a high prevalence of sleep apnea in persons with spinal cord injury, relatively little has been published regarding treatment of sleep apnea in this population. The purpose of this study was to describe long-term treatment outcomes and side effects of sleep apnea treatment in persons with spinal cord injury.
[Case of obstructive sleep apnea syndrome exacerbated due to cervical spinal cord injury]. [2013]A 70-year-old man injured his spinal cord at the fourth cervical vertebra due to a fall and became quadriplegic. Following emergency treatment, the patient was admitted to our hospital for rehabilitation. On admission, respiratory function tests indicated a percent vital capacity value (%VC) of 58.6%, revealing restrictive ventilatory impairment. After admission, we observed difficulty breathing at night and extreme snoring and thus performed a simple full-night polysomnography. Results showed an apnea-hypopnea index (AHI) of 46.5/hr and serious obstructive sleep apnea syndrome (OSAS). Based on these results, we conjectured that a preexisting OSAS condition was exacerbated by the cervical spinal cord injury, and thus administered nasal continuous positive airway pressure (NCPAP) in addition to respiratory rehabilitation. A speedy disappearance of clinical symptoms was found with the application of NCPAP. Compared to a 3% oxygen desaturation index (ODI 3%) of 31.0 dips/hr prior to treatment, the ODI 3% dropped to 3.5 dips/hr after 14 days, and 0 dips/hr after 60 days, indicating an obvious improvement in nocturnal oxygen desaturation.
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]Mixed methods OBJECTIVES: Continuous positive airway pressure (CPAP) therapy is the recommended treatment for obstructive sleep apnoea (OSA). The aim of this study was to estimate CPAP adherence in people with tetraplegia and OSA, and to explore the barriers and facilitators to CPAP use.
Factors influencing adherence to continuous positive airway pressure devices in individuals with spinal cord injury and sleep apnea: Results of a qualitative study. [2021]In individuals with spinal cord injury (SCI) and sleep apnea (SA), adherence to continuous positive airway pressure (CPAP) therapy seems unsatisfactory despite technical and educational support implemented when starting treatment.
Continuous Positive Airway Pressure Use for Obstructive Sleep Apnea in Acute, Traumatic Tetraplegia. [2020]To describe continuous positive airway pressure (CPAP) use for treatment of obstructive sleep apnea (OSA) in acute tetraplegia, including adherence rates and associated factors.
Noninvasive Ventilation and Spinal Cord Injury. [2021]Individuals with spinal cord injury (SCI) are at increased risk of respiratory complications during wake and sleep. Sleep-disordered breathing (SDB) is commonly associated with SCI and requires an individualized approach to its management. Respiratory control plays a key role in the pathogenesis of SDB in cervical SCI. Noninvasive ventilation plays an important role in the management of respiratory complications in individuals with SCI acutely and in chronic phases. Positive airway pressure treatment may be effective in eliminating SDB and improving sleepiness symptoms, but adherence to treatment is poor and effect on long-term outcomes is questionable.
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]Respiratory muscle paralysis due to low cervical spinal cord injury (CSCI) can lead to dysphagia. Noninvasive positive airway pressure (PAP) therapy can effectively treat this type of dysphagia. High-flow nasal cannula (HFNC) oxygen therapy can generate a low level of positive airway pressure resembling PAP therapy, it may improve the dysphagia.