CPAP Therapy for Sleep Apnea

Overseen By Mitsue Aibe

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University Health Network, Toronto

Disqualifiers: Sleep apnea, CNS diseases, Substance misuse, others

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

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 16 weeks

15 Participants Needed

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.

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 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. ^{1 2 3 4 5}

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. ^{2 6 7 8 9}

How 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. ^{1 7 9 10 11}

Research Team

Dr. Julio Furlan

Principal Investigator

University Health Network, Toronto

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 play a wheelchair sport at a competitive level.

Exclusion Criteria

I have no brain or nervous system diseases.

Current substance misuse

I have a history of severe daytime sleepiness not caused by sleep-related breathing disorders.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo a 4-month trial of Continuous Positive Airway Pressure (CPAP) therapy

16 weeks

Follow-up

Participants are monitored for changes in cognitive impairment, sleep quality, and sports performance after CPAP therapy

4 weeks

Treatment Details

Interventions

• CPAP Therapy

Trial Overview 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.

Participant Groups

Group I: CPAP Therapy Experimental Treatment 1 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

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+

Findings from Research

A study involving 300 CPAP-naive patients with moderate to severe obstructive sleep apnea found that a combination of individual and group education significantly improved adherence to CPAP therapy, with a drop-out rate of only 5% in the group receiving this approach.

Patients in the group that received both individual and group education used CPAP for an average of 5.7 hours per night, which was significantly higher than the 4.7 hours in the individual education only group, highlighting the effectiveness of enhanced educational strategies in promoting therapy adherence.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adherence to CPAP therapy: comparing the effect of three educational approaches in patients with obstructive sleep apnoea. Delanote, I., Borzée, P., Belge, C., et al.[2018]

The nurse practitioner-led MENDS intervention, which included virtual motivational support for CPAP users, was feasible with high completion rates and minimal technical issues, indicating it could be a practical approach to improve adherence in patients with Obstructive Sleep Apnea (OSA).

While the study did not find statistically significant differences in CPAP adherence or patient-reported outcomes between the MENDS and usual care groups, higher adherence was linked to improvements in fatigue, sleep disturbance, and anxiety, suggesting that better CPAP use can enhance overall patient well-being.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Nurse practitioner-led, virtually delivered, motivational enhancement and device support intervention to improve CPAP adherence: A feasibility randomized control trial. Miller, JN., Kupzyk, K., Zheng, C., et al.[2023]

A newly developed telemonitoring system for CPAP therapy was designed through a comprehensive process involving input from sleep specialists, patients, and system developers, aiming to enhance adherence in patients with obstructive sleep apnea (OSA).

Usability tests indicated that while there were some functionality issues reported by users, the system has the potential to improve communication and support for patients, which could lead to better adherence to CPAP therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A telemonitoring system to support CPAP therapy in patients with obstructive sleep apnea: a participatory approach in analysis, design, and evaluation. Aalaei, S., Amini, M., Mazaheri Habibi, MR., et al.[2022]

Short-term CPAP treatment (less than 3 months) significantly improves inflammatory biomarkers like C-reactive protein (CRP) and tumor necrosis factor-α (TNF-α), as well as glycolipid metabolic markers such as fasting blood glucose (FBG) and low-density lipoprotein (LDL).

Mid-term (3-6 months) and long-term (6 months or more) CPAP treatment leads to improvements in high-density lipoprotein (HDL) and total cholesterol (TC), indicating that the benefits of CPAP on biomarkers are time-dependent.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Changes of circulating biomarkers of inflammation and glycolipid metabolism by CPAP in OSA patients: a meta-analysis of time-dependent profiles. Wang, Y., Lin, YN., Zhang, LY., et al.[2022]

CPAP therapy effectively reduces the respiratory disturbance index (RDI) and the number of arousals while increasing arterial oxygen saturation (SaO2) in patients with obstructive sleep apnea, confirming its physiological benefits.

However, in this study of 48 patients, CPAP did not show a significant improvement in sleep quality compared to a placebo CPAP, indicating that while it helps with certain metrics, it may not enhance overall sleep architecture in the short term.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of continuous positive airway pressure vs placebo continuous positive airway pressure on sleep quality in obstructive sleep apnea. Loredo, JS., Ancoli-Israel, S., Dimsdale, JE.[2022]

A study involving in-depth interviews with 61 Jewish-Israeli patients with obstructive sleep apnea revealed that both users and nonusers of CPAP therapy experience ambivalence about their treatment, indicating a complex relationship with the device.

The findings suggest that adherence to CPAP is not a straightforward decision; both users and nonusers often reconsider their choices, highlighting the need for ongoing support and follow-up for all patients to address their concerns and improve adherence.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Ambivalent Adherence and Nonadherence to Continuous Positive Airway Pressure Devices: A Qualitative Study. Zarhin, D., Oksenberg, A.[2022]

In a study of 54 patients with sleep apnoea/hypopnoea syndrome, the average nightly usage of CPAP therapy was only 4.7 hours, which is less than the recommended duration for effective treatment.

There was no correlation between the severity of sleep apnoea and the amount of CPAP used, and patients who experienced side effects from the therapy tended to use it significantly less, highlighting the importance of monitoring and addressing side effects to improve compliance.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Compliance with CPAP therapy in patients with the sleep apnoea/hypopnoea syndrome. Engleman, HM., Martin, SE., Douglas, NJ.[2019]

In a study of 246 patients with obstructive sleep apnea syndrome (OSAS), those using CPAP therapy, especially without a heated humidifier, experienced significantly higher rates of upper airway infections compared to those receiving conservative treatment.

Patients using CPAP with a heated humidifier also reported increased infections, particularly if they did not maintain proper hygiene of their devices, highlighting the importance of regular cleaning to reduce infection risk.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of continuous positive airway pressure therapy on infectious complications in patients with obstructive sleep apnea syndrome. Sanner, BM., Fluerenbrock, N., Kleiber-Imbeck, A., et al.[2022]

CPAP therapy is effective for treating moderate to severe obstructive sleep apnea, but standard mask designs often do not fit individual patients well, which can affect treatment compliance and effectiveness.

Customizing CPAP masks to fit individual characteristics, such as face shape and skin sensitivity, could improve patient comfort and reduce skin damage, with emerging technologies like 3D printing showing promise for creating tailored solutions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mask interface for continuous positive airway pressure therapy: selection and design considerations. Ma, Z., Drinnan, M., Hyde, P., et al.[2019]

In a study involving 36 outpatients with obstructive sleep apnea syndrome (OSAS), automatic CPAP machines using estimated reference pressures were found to be as effective as those using fixed pressures in alleviating sleep and breathing disorders.

The results suggest that automatic CPAP can be effectively administered without the need for a titration sleep study, allowing for easier adjustments based on individual characteristics, although one patient did experience treatment failure due to an underestimated pressure.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of automatic continuous positive airway pressure therapy that uses an estimated required pressure in the treatment of the obstructive sleep apnea syndrome. Sériès, F., Marc, I.[2019]

In a study involving 98 subjects with obstructive sleep apnoea (OSA), different methods of CPAP pressure delivery (autotitration vs. fixed pressure) showed no significant differences in clinical outcomes after 6 months of treatment.

The findings suggest that the method of determining CPAP pressure does not impact the effectiveness of treatment for OSA, indicating that simpler methods may be just as effective as more complex autotitration systems.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison of three ways to determine and deliver pressure during nasal CPAP therapy for obstructive sleep apnoea. West, SD., Jones, DR., Stradling, JR.[2018]

References

1. England pubmed.ncbi.nlm.nih.gov

Adherence to CPAP therapy: comparing the effect of three educational approaches in patients with obstructive sleep apnoea. [2018]

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

Nurse practitioner-led, virtually delivered, motivational enhancement and device support intervention to improve CPAP adherence: A feasibility randomized control trial. [2023]

3. England pubmed.ncbi.nlm.nih.gov

A telemonitoring system to support CPAP therapy in patients with obstructive sleep apnea: a participatory approach in analysis, design, and evaluation. [2022]

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

Changes of circulating biomarkers of inflammation and glycolipid metabolism by CPAP in OSA patients: a meta-analysis of time-dependent profiles. [2022]

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

Effect of continuous positive airway pressure vs placebo continuous positive airway pressure on sleep quality in obstructive sleep apnea. [2022]

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

Ambivalent Adherence and Nonadherence to Continuous Positive Airway Pressure Devices: A Qualitative Study. [2022]

7. England pubmed.ncbi.nlm.nih.gov

Compliance with CPAP therapy in patients with the sleep apnoea/hypopnoea syndrome. [2019]

8. Switzerland pubmed.ncbi.nlm.nih.gov

Effect of continuous positive airway pressure therapy on infectious complications in patients with obstructive sleep apnea syndrome. [2022]

9. England pubmed.ncbi.nlm.nih.gov

Mask interface for continuous positive airway pressure therapy: selection and design considerations. [2019]

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

Efficacy of automatic continuous positive airway pressure therapy that uses an estimated required pressure in the treatment of the obstructive sleep apnea syndrome. [2019]

11. England pubmed.ncbi.nlm.nih.gov

Comparison of three ways to determine and deliver pressure during nasal CPAP therapy for obstructive sleep apnoea. [2018]