CPAP vs BiPAP for Sleep Apnea

Overseen By Viet Vu

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of British Columbia

Disqualifiers: On CPAP or BiPAP, Hypoventilation syndrome

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

Compensation: Varies

Number of Visits: 3

Duration: 4 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial compares two types of breathing machines, CPAP and BiPAP, for individuals with sleep-disordered breathing after a cervical spinal cord injury. The goal is to determine if BiPAP, which provides varying air pressure during inhalation and exhalation, is easier to use than CPAP, which maintains constant pressure. Participants will use one of the machines for four weeks to assess which improves sleep and reduces daytime tiredness more effectively. The trial seeks adults with a cervical spinal cord injury and moderate to severe sleep-disordered breathing. As an unphased trial, it offers participants the chance to contribute to research that could enhance sleep quality and daytime alertness for others with similar conditions.

Do I need to stop my current medications for this trial?

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 prior data suggests that these devices are safe for individuals with cervical spinal cord injuries?

A previous study demonstrated that CPAP (Continuous Positive Airway Pressure) therapy improved the quality of life for individuals with moderate to severe sleep apnea. It also reduced the risk of heart problems and decreased the likelihood of death from related issues. Users of CPAP reported feeling less sleepy during the day and noticed other symptom improvements.

Research has shown that BiPAP (Bilevel Positive Airway Pressure) therapy, which uses different air pressures for inhalation and exhalation, offers similar benefits. Some individuals find BiPAP more comfortable than CPAP. However, BiPAP can sometimes cause minor issues such as skin irritation from the mask, dry mouth, or mild stomach bloating.

Both CPAP and BiPAP have been used safely to treat sleep apnea. The choice between them often depends on individual comfort and preference. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about CPAP and BiPAP therapies for sleep apnea because they each offer unique approaches to managing this condition. Unlike the standard CPAP machines, which provide a constant stream of air pressure, BiPAP machines offer two levels of pressure: one for inhaling and a lower one for exhaling. This can make breathing more comfortable for some patients, especially those with more severe sleep apnea or other respiratory issues. By comparing these two methods, researchers hope to find out which therapy is more effective or better tolerated, potentially improving sleep quality and overall health for those with sleep apnea.

What evidence suggests that this trial's treatments could be effective for sleep apnea?

This trial will compare CPAP (Continuous Positive Airway Pressure) with BiPAP (Bilevel Positive Airway Pressure) for treating sleep apnea. Research has shown that CPAP can improve the quality of life for individuals with moderate to severe sleep apnea. Studies have found that using CPAP for at least four hours each night can lower the risk of death and reduce heart problems. Evidence suggests that BiPAP might be easier for some to adhere to, as it uses different air pressures when inhaling and exhaling, which can feel more comfortable. BiPAP has been linked to a significant drop in the apnea-hypopnea index, effectively reducing symptoms. Both treatments are effective, but BiPAP might offer more comfort for some, potentially leading to better adherence. ^{2 4 5 6 7}

Are You a Good Fit for This Trial?

This trial is for adults with cervical spinal cord injuries who experience moderate to severe sleep-disordered breathing, indicated by frequent interruptions in breathing during sleep. Participants should have a history of difficulty with or discomfort using CPAP machines.

Inclusion Criteria

Presence of sleep disordered breathing, defined as AHI >=15 events/hour by home sleep apnea test (HSAT)

I am 19 years old or older.

I have a cervical spinal cord injury.

Exclusion Criteria

On CPAP or BiPAP prior to spinal cord injury

I have a condition where my breathing is too shallow or slow.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants are randomly assigned to either CPAP or BiPAP therapy for 4 weeks. Device usage per night is measured, and data on daytime sleepiness, fatigue, and sleep quality is collected at baseline, 2 weeks, and 4 weeks.

4 weeks

3 visits (in-person or virtual) at baseline, 2 weeks, and 4 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• BiPAP
• CPAP

Trial Overview The study compares two treatments for sleep-disordered breathing: CPAP, which uses constant air pressure, and BiPAP, which varies the pressure between inhalation and exhalation. The goal is to see if BiPAP leads to better use at night and improves daytime symptoms over a period of 4 weeks.

How Is the Trial Designed?

Group I: CPAP Therapy Experimental Treatment 1 Intervention

Group II: BiPAP Therapy Experimental Treatment 1 Intervention

Who Is Running the Clinical Trial?

University of British Columbia

Lead Sponsor

Trials

1,506

Recruited

2,528,000+

Published Research Related to This Trial

Nasal continuous positive airway pressure (CPAP) is an effective treatment for obstructive sleep apnea (OSA), but it can cause side effects that may lead to discontinuation of therapy.

In this report, two patients developed irritant contact dermatitis (ICD) after using CPAP masks for several years, highlighting a potential skin-related side effect of long-term CPAP use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Irritant contact dermatitis due to the use of a continuous positive airway pressure nasal mask: 2 case reports and review of the literature. Egesi, A., Davis, MD.[2013]

In a study of 502 patients over one year, 1-2% experienced serious complications from CPAP and BIPAP treatments for sleep-related breathing disorders, including long central apneas and severe hypoxemia.

Mask leakages and central apneas were common issues that could lead to ineffective therapy, highlighting the need for initial treatment to be conducted in controlled sleep laboratory settings to ensure patient safety.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Errors and risks in administration of nasal respiratory therapy of obstructive sleep apnea]. Stammnitz, A., Becker, H., Schneider, H., et al.[2016]

A case report highlights a rare but serious complication of using BiPAP after surgery for a brain tumor, where the patient developed severe pneumocephalus, leading to an unplanned ICU admission.

The authors recommend caution when using CPAP or BiPAP in postoperative patients, especially those who have undergone head and neck procedures, due to potential risks.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pneumocephalus with BiPAP use after transsphenoidal surgery. Kopelovich, JC., de la Garza, GO., Greenlee, JD., et al.[2022]

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10838662/

Positive airway pressure therapy adherence and outcomes in ... Observational studies have found a significant reduction in mortality with four or more hours per night of PAP therapy compared to no usage; ...

2. cjrt.ca cjrt.ca/article/92080-positive-airway-pressure-therapy-adherence-and-outcomes-in-obstructive-sleep-apnea-an-exploratory-longitudinal-retrospective-randomized-chart-review

Positive airway pressure therapy adherence and outcomes ... The present study sought to determine the efficacy of the present definition of PAP therapy adherence on longitudinal outcomes in patients with OSA.

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4543258/

Efficacy of Bilevel-auto Treatment in Patients with ... The apnea-hypopnea index decreased significantly during CPAP in both groups; however, in the group A, there was a further significant improvement during Bilevel ...

4. jcsm.aasm.org jcsm.aasm.org/doi/10.5664/jcsm.7638

Treatment of Adult Obstructive Sleep Apnea With Positive ... The data demonstrated that PAP compared to no treatment results in a clinically significant reduction in disease severity, sleepiness, blood pressure, and motor ...

5. clinicaltrials.gov clinicaltrials.gov/study/NCT00458406

Study Details | NCT00458406 | Evaluation of Adherence ... Objectives: The primary objective of this study is to determine whether BiPAP with Bi-Flex results in improvement in adherence as compared to CPAP. The ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3119924/

CPAP and Bi-level PAP Therapy: New and Established Roles PAP therapy splints the upper airway (black crosses and arrows), achieves positive intrathoracic pressure (white crosses), decreases venous return, increases ...

7. hopkinsmedicine.org hopkinsmedicine.org/health/treatment-tests-and-therapies/bipap

BiPap What are the risks of BiPap use? · Local skin damage from the mask · Mild stomach bloating · Dry mouth · Leaking from the mask, causing less pressure to be ...