Overseen ByDr. Julio Furlan
Age: 18+
Sex: Any
Travel: May be covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: University Health Network, Toronto
No Placebo Group
Approved in 3 jurisdictions
Trial Summary
What is the purpose of this trial?This single arm clinical trial will assess whether continuous positive airway pressure (CPAP) therapy in the management of moderate-to-severe sleep-related breathing disorders (SRBDs) among para-athletes living with cervical/thoracic, complete or incomplete spinal cord injury (SCI) is effective in improving cognitive impairment, in reducing fatigue, depression, anxiety, and overall quality of life. Further, the study will evaluate the effectiveness of CPAP therapy in improving their performance in sports and the perceived risk of injuries.
Is CPAP therapy safe for humans?
CPAP therapy is generally considered safe for humans, but it can have frequent side effects, such as discomfort from the mask or nasal issues.
147811What data supports the effectiveness of CPAP therapy for sleep apnea?
Research shows that CPAP therapy is the preferred treatment for moderate to severe obstructive sleep apnea (OSA) and can improve important outcomes like sleep quality. However, many patients find it hard to stick with the treatment, which can limit its benefits.
3691011How is CPAP therapy different from other treatments for sleep apnea?
CPAP therapy is unique because it uses a machine to deliver continuous air pressure through a mask to keep the airways open during sleep, unlike other treatments that might involve surgery or oral appliances. It is the first-line treatment for moderate to severe obstructive sleep apnea, but its effectiveness can be limited by poor adherence due to the obtrusiveness of the mask and machine.
12568Will 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.
Eligibility Criteria
This trial is for para-athletes in Ontario with spinal cord injuries who have moderate-to-severe sleep-related breathing disorders. Participants should be experiencing issues like cognitive impairment, fatigue, depression, or anxiety and are looking to improve their quality of life and sports performance.Inclusion Criteria
I have had a spinal cord injury in my neck or upper back for more than 6 months.
I am 18 or older and speak English.
Exclusion Criteria
I have no brain or nervous system diseases.
I have a history of severe daytime sleepiness not caused by sleep-related breathing disorders.
Participant Groups
The study is testing if CPAP therapy can help these athletes by improving mental sharpness, reducing tiredness and negative feelings, enhancing overall well-being, and lowering the chance of sports injuries.
1Treatment groups
Experimental Treatment
Group I: CPAP TherapyExperimental Treatment1 Intervention
Participants who are diagnosed with moderate-to-severe sleep related breathing disorders (SRBDs) will undergo a 4-month trial of Continuous positive airway pressure (CPAP) therapy.
CPAP Therapy is already approved in United States, Canada, European Union for the following indications:
🇺🇸 Approved in United States as CPAP Therapy for:
- Obstructive Sleep Apnea
- Central Sleep Apnea
- Mixed Sleep Apnea
- Sleep-Related Breathing Disorders
🇨🇦 Approved in Canada as CPAP Therapy for:
- Obstructive Sleep Apnea
- Central Sleep Apnea
- Mixed Sleep Apnea
- Sleep-Related Breathing Disorders
🇪🇺 Approved in European Union as CPAP Therapy for:
- Obstructive Sleep Apnea
- Central Sleep Apnea
- Mixed Sleep Apnea
- Sleep-Related Breathing Disorders
Find A Clinic Near You
Research locations nearbySelect from list below to view details:
Toronto Rehab - Lyndhurst CentreToronto, Canada
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Who is running the clinical trial?
University Health Network, TorontoLead Sponsor
Sunnybrook Health Sciences CentreCollaborator
References
Compliance with CPAP therapy in patients with the sleep apnoea/hypopnoea syndrome. [2019]Continuous positive airway pressure (CPAP) therapy is the treatment of choice for the sleep apnoea/hypopnoea syndrome. Compliance with this relatively obtrusive therapy has not been well studied.
Efficacy of automatic continuous positive airway pressure therapy that uses an estimated required pressure in the treatment of the obstructive sleep apnea syndrome. [2019]Continuous positive airway pressure (CPAP) is effective therapy for the obstructive sleep apnea syndrome (OSAS). Automatic CPAP devices continuously adjust the positive pressure to the required levels.
Effect of continuous positive airway pressure vs placebo continuous positive airway pressure on sleep quality in obstructive sleep apnea. [2022]Continuous positive airway pressure (CPAP) therapy has become the treatment of choice for obstructive sleep apnea (OSA). However, the efficacy of CPAP therapy has not been evaluated against a suitable control. We investigated the effectiveness of CPAP therapy in improving sleep quality in patients with OSA. We hypothesized that CPAP improves sleep quality.
Effect of continuous positive airway pressure therapy on infectious complications in patients with obstructive sleep apnea syndrome. [2022]Nasal continuous positive airway pressure (CPAP) is a well-established, widely used and effective treatment of obstructive sleep apnea syndrome (OSAS). Unfortunately, side effects are frequent during CPAP treatment.
Comparison of three ways to determine and deliver pressure during nasal CPAP therapy for obstructive sleep apnoea. [2018]The simplest method of initiating and maintaining therapeutic continuous positive airways pressure (CPAP) therapy for obstructive sleep apnoea (OSA) has not been established.
Adherence to CPAP therapy: comparing the effect of three educational approaches in patients with obstructive sleep apnoea. [2018]Continuous positive airway pressure (CPAP)-therapy is the first-line treatment for moderate to severe obstructive sleep apnoea (OSA). A significant limitation of CPAP treatment is the poor therapy adherence, compromising the beneficial effects.
Ambivalent Adherence and Nonadherence to Continuous Positive Airway Pressure Devices: A Qualitative Study. [2022]Continuous positive airway pressure (CPAP) therapy is considered the front-line treatment for moderate-severe obstructive sleep apnea (OSA). However, nonuse rates are very high, such that adherence to CPAP has become a major concern. Although the literature on CPAP use is vast, further research is required to understand patients' experiences of CPAP use and nonuse. This is the goal of this study.
Mask interface for continuous positive airway pressure therapy: selection and design considerations. [2019]Continuous positive airway pressure (CPAP) therapy is a clinical treatment for moderate or severe obstructive sleep apnea (OSA). Commercial CPAP mask designs normally come in standard sizes and the configuration is not commonly tailored to the patients' characteristics such as face topology, skin sensitivity, and severity of OSA syndrome; however, an optimal mask/interface selection is a key factor influencing the compliance and effectiveness of CPAP treatment.
Changes of circulating biomarkers of inflammation and glycolipid metabolism by CPAP in OSA patients: a meta-analysis of time-dependent profiles. [2022]Continuous positive airway pressure (CPAP) is the first-line therapy for moderate-to-severe obstructive sleep apnea (OSA). Specifying timing of CPAP benefits on OSA-related biomarkers will help to assess the effectiveness of CPAP and to optimize the treatment strategies.
A telemonitoring system to support CPAP therapy in patients with obstructive sleep apnea: a participatory approach in analysis, design, and evaluation. [2022]Continues positive airway pressure (CPAP) therapy is a gold standard treatment for moderate to severe cases of OSA (obstructive sleep apnea). The present research aimed to describe the analysis, design, and evaluation of a telemonitoring system to improve CPAP adherence in patients afflicted with OSA.
Nurse practitioner-led, virtually delivered, motivational enhancement and device support intervention to improve CPAP adherence: A feasibility randomized control trial. [2023]Evidence indicates continuous positive airway pressure (CPAP) therapy improves several important patient-centered outcomes. However, adherence to this safe and effective intervention remains poor.