CPAP Therapy for Sleep Apnea

Overseen By Scott A Sands, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Brigham and Women's Hospital

Disqualifiers: Severe mouth-breathing, cardiovascular, pulmonary, others

Compensation: Varies

Number of Visits: Unknown

Duration: 1 year

13 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines how different CPAP mask designs can improve airflow and reduce the rebreathing of exhaled carbon dioxide (CO₂) for individuals with obstructive sleep apnea (OSA). The researchers are testing several CPAP setups and comparing them to determine which is most effective. Individuals with moderate to severe OSA who have previously used CPAP, but do not have severe mouth-breathing or other major sleep disorders, may be suitable candidates.

As an unphased trial, this study provides participants the opportunity to contribute to innovative research that could enhance CPAP therapy for many.

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 prior data suggests that CPAP therapy is safe for individuals with obstructive sleep apnea?

Research has shown that a CPAP machine is generally well-tolerated by people with obstructive sleep apnea (OSA). Studies have found that CPAP can improve the quality of life for those with moderate to severe sleep apnea. However, some common issues can occur, such as a leaky mask, trouble sleeping, or a dry mouth. These problems are usually easy to fix with a few adjustments.

Research has also observed that people using CPAP might have a lower risk of serious health issues like stroke and heart attack compared to those who don't use it. While CPAP can have side effects, they are often minor and manageable. Overall, CPAP is considered a safe treatment for sleep apnea. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about these CPAP therapy trials for sleep apnea because they explore different combinations of pressure settings and airflow. Unlike standard CPAP machines that typically use a fixed pressure and exhaust flow, this trial examines various pressure levels (5 cmH₂O and 10 cmH₂O) with different exhaust flows ranging from 8 L/s to 35 L/s. By testing these combinations, researchers aim to find the most effective setup for reducing symptoms and improving comfort, potentially leading to better patient compliance and outcomes.

What evidence suggests that CPAP therapy is effective for sleep apnea?

Studies have shown that CPAP therapy effectively treats obstructive sleep apnea (OSA). Research indicates that CPAP use improves the quality of life for individuals with moderate to severe sleep apnea. Regular CPAP use—at least four hours each night—lowers the risks of death and heart problems. It also reduces the likelihood of hospital visits for heart issues and accidents. Overall, CPAP use provides significant health benefits for those with sleep apnea. ^{1 6 7 8 9}

Who Is on the Research Team?

Atqiya Aishah, PhD

Principal Investigator

Harvard Medical School & Brigham and Women's Hospital

Are You a Good Fit for This Trial?

This trial is for individuals with obstructive sleep apnea (OSA). Specific eligibility criteria are not provided, so it's best to contact the research team for details on who can participate.

Inclusion Criteria

Self-reported CPAP users or have previously used CPAP

Self-reported holding pressure of maximum 13 cmH2O (if known)

BMI: 18-40 kg/m2

Exclusion Criteria

Requirement for nocturnal supplemental oxygen or other ventilatory support

I mainly breathe through my mouth due to its severity.

I do not have severe heart or lung disease.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo CPAP therapy with varying exhaust flow rates and pressures to assess rebreathing and hypoxic load

1 year

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Continuous positive airway pressure (CPAP)

Trial Overview The study is examining how different CPAP mask designs influence airflow and the rebreathing of exhaled CO₂ during sleep in people with OSA. It aims to improve understanding of CPAP therapy effectiveness.

How Is the Trial Designed?

Group I: 5 cmH2O with 8L/s Experimental Treatment 2 Interventions

8 L/s exhaust flow with 5 cmH₂O PAP

Group II: 5 cmH2O with 35L/s Experimental Treatment 2 Interventions

35 L/s exhaust flow with 5 cmH₂O PAP

Group III: 5 cmH2O with 23L/s Experimental Treatment 2 Interventions

23 L/s exhaust flow with 5 cmH₂O PAP

Group IV: 5 cmH2O with 18L/s Experimental Treatment 2 Interventions

18 L/s exhaust flow with 5 cmH₂O PAP

Group V: 5 cmH2O with 13L/s Experimental Treatment 2 Interventions

13 L/s exhaust flow with 5 cmH₂O PAP

Group VI: 10 cmH2O with 8L/s Experimental Treatment 2 Interventions

8 L/s exhaust flow with 10 cmH₂O PAP

Group VII: 10 cmH2O with 35L/s Experimental Treatment 2 Interventions

35 L/s exhaust flow with 10 cmH₂O PAP

Group VIII: 10 cmH2O with 23L/s Experimental Treatment 2 Interventions

23 L/s exhaust flow with 10 cmH₂O PAP

Group IX: 10 cmH2O with 18L/s Experimental Treatment 2 Interventions

18 L/s exhaust flow with 10 cmH₂O PAP

Group X: 10 cmH2O with 13L/s Experimental Treatment 2 Interventions

13 L/s exhaust flow with 10 cmH₂O PAP

Group XI: 0 cmH2O with 35L/s Placebo Group 1 Intervention

35 L/s exhaust flow with 0 cmH₂O PAP

Who Is Running the Clinical Trial?

Brigham and Women's Hospital

Lead Sponsor

Trials

1,694

Recruited

14,790,000+

Sleep Res, Inc.

Collaborator

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5436801/

IMPACT OF CONTINOUS POSITIVE AIRWAY PRESSURE ... We found that long-term improvement in quality of life occurs with the use of CPAP in persons with severe and possibly moderate sleep apnea.

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 ... Observational studies have found a significant reduction in mortality with four or more hours per night of PAP therapy compared to no usage9–12; ...

3. sciencedirect.com sciencedirect.com/science/article/pii/S2590041224000151

Continuous positive airway pressure treatment for ... CPAP patients had less hospitalizations for CV disease complications and trauma which reflect a potential decrease in CV risks and in the number of road, ...

4. jamanetwork.com jamanetwork.com/journals/jamanetworkopen/fullarticle/2823539

Positive Airway Pressure, Mortality, and CV Risk in Older ... In this cohort study of Medicare beneficiaries with OSA, PAP utilization was associated with lower all-cause mortality and MACE incidence.

5. jcsm.aasm.org jcsm.aasm.org/doi/10.5664/jcsm.10740

Effects of continuous positive airway pressure on cardiac ... Conclusions: CPAP therapy might prevent subsequent MACEs and all-cause death among patients with moderate to severe obstructive sleep apnea and concomitant ...

6. mayoclinic.org mayoclinic.org/diseases-conditions/sleep-apnea/in-depth/cpap/art-20044164

CPAP machines: Tips for avoiding 10 common problems Common problems with CPAP include a leaky mask, trouble falling asleep, a stuffy nose and a dry mouth.

7. hopkinsmedicine.org hopkinsmedicine.org/health/wellness-and-prevention/the-dangers-of-uncontrolled-sleep-apnea

The Dangers of Uncontrolled Sleep Apnea In some observational studies that compare people with apnea who use CPAP versus those who don't, the CPAP users have lower risk of stroke and heart attack and ...

8. sciencedirect.com sciencedirect.com/science/article/pii/S1389945724001096

Real-world impact of continuous positive airway pressure ... Excessive daytime sleepiness in obstructive sleep apnea patients treated with continuous positive airway pressure: data from the European Sleep Apnea Database.

9. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/10.1111/resp.13808

Clinical side effects of continuous positive airway pressure ... This review highlights the range of side effects associated with CPAP therapy in patients with OSA. This information is important for the initiation of ...