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

32 Participants Needed

Trial Summary

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 data supports the effectiveness of the treatment BiPAP for sleep apnea?

Research shows that BiPAP can be effective for patients with obstructive sleep apnea who do not respond well to CPAP, as it helps improve breathing by providing different pressure levels for inhaling and exhaling. ^{1 2 3 4 5}

Is CPAP or BiPAP generally safe for humans?

CPAP and BiPAP are generally safe for treating sleep apnea, but some people may experience side effects like skin irritation from the mask or rare complications like breathing issues during sleep. It's important to monitor for any unusual symptoms and consult with a healthcare provider. ^{4 6 7 8 9}

How does the CPAP vs BiPAP treatment for sleep apnea differ from other treatments?

CPAP (Continuous Positive Airway Pressure) and BiPAP (Bilevel Positive Airway Pressure) are unique treatments for sleep apnea that use a machine to deliver air pressure through a mask to keep airways open during sleep. Unlike other treatments, CPAP provides a constant pressure, while BiPAP offers two levels of pressure: higher when you inhale and lower when you exhale, which can be more comfortable for some patients. ^{7 10 11 12 13}

What is the purpose of this trial?

Sleep-disordered breathing (SDB) is common in individuals with cervical spinal cord injuries, with studies suggesting prevalence rates ranging from 27% to 62%. The condition often leads to daytime sleepiness, fatigue, and poor participation in rehabilitation. Positive airway pressure therapy can be used to treat the condition; however, some individuals find continuous positive airway pressure (CPAP), which applies the same pressure during inhalation and exhalation, difficult to use. Bilevel positive airway pressure (BiPAP) offers different pressures for inhalation and exhalation, which may be more comfortable and potentially improve adherence in this patient population. However, limited evidence compares CPAP and BiPAP in individuals with cervical spinal cord injuries. This pilot study will enroll 32 adult participants with cervical spinal cord injuries who have moderate to severe SDB (defined as an AHI of 15 events/hour or greater). Participants will be randomly assigned to either CPAP or BiPAP therapy for 4 weeks. Device usage per night will be measured, and data on daytime sleepiness, fatigue, and sleep quality will be collected at baseline, 2 weeks, and 4 weeks. The investigators aim to determine whether BiPAP improves adherence and symptoms compared to CPAP in this patient population.

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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 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]

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 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]

References

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

Failure of CPAP therapy in obstructive sleep apnoea syndrome: predictive factors and treatment with bilevel-positive airway pressure. [2019]

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

Noninvasive positive pressure ventilation in infants with upper airway obstruction: comparison of continuous and bilevel positive pressure. [2022]

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

Non-invasive ventilation in acute respiratory failure: a randomised comparison of continuous positive airway pressure and bi-level positive airway pressure. [2019]

4. Czech Republic pubmed.ncbi.nlm.nih.gov

Risk factors for failure of continuous positive airway pressure treatment in patients with ostructive sleep apnoea. [2018]

5. England pubmed.ncbi.nlm.nih.gov

Upper airway surgery benefits patients with obstructive sleep apnoea who cannot tolerate nasal continuous positive airway pressure. [2019]

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

Pneumocephalus with BiPAP use after transsphenoidal surgery. [2022]

7. Germany pubmed.ncbi.nlm.nih.gov

[Errors and risks in administration of nasal respiratory therapy of obstructive sleep apnea]. [2016]

8. United States 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. [2013]

9. Switzerland pubmed.ncbi.nlm.nih.gov

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

10. Germany pubmed.ncbi.nlm.nih.gov

[Technical differences in various CPAP and BiLevel CPAP devices]. [2009]

11. Netherlands pubmed.ncbi.nlm.nih.gov

Severity of nocturnal hypoxia and daytime hypercapnia predicts CPAP failure in patients with COPD and obstructive sleep apnea overlap syndrome. [2022]

12. Germany pubmed.ncbi.nlm.nih.gov

[Effect of CPAP and BIPAP on stroke volume in patients with obstructive sleep apnea syndrome]. [2009]

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

Postoperative CPAP and BiPAP use can be safely omitted after laparoscopic Roux-en-Y gastric bypass. [2008]