Image

Assessment of Circuit Rebreathing During CPAP Therapy

Assessment of Circuit Rebreathing During CPAP Therapy

Recruiting
21-70 years
All
Phase N/A

Powered by AI

Overview

The goal of this research is to better understand how different CPAP mask designs affect airflow and rebreathing of exhaled carbon dioxide (CO₂) during sleep in individuals with obstructive sleep apnea (OSA).

Description

To understand the existence and severity of circuit rebreathing during treatment with continuous positive airway pressure (CPAP) using different sizes of the exhaust ports in individuals with obstructive sleep apnea (OSA).

Flow-adjusted end-tidal oxygen (PetO2) and carbon dioxide (PetCO2) will be assessed to determine the magnitude of hypoxic load during both wakefulness and sleep. To systematically assess these conditions, the conditions were defined as follows:

  • 5A: 35 L/s exhaust flow with 5 cmH₂O PAP
  • 5B: 23 L/s exhaust flow with 5 cmH₂O PAP
  • 5C: 18 L/s exhaust flow with 5 cmH₂O PAP
  • 5D: 13 L/s exhaust flow with 5 cmH₂O PAP
  • 5E: 8 L/s exhaust flow with 5 cmH₂O PAP
  • 0P: 35 L/s exhaust flow with 0 cmH₂O PAP
  • 10A: 35 L/s exhaust flow with 10 cmH₂O PAP
  • 10B: 23 L/s exhaust flow with 10 cmH₂O PAP
  • 10C: 18 L/s exhaust flow with 10 cmH₂O PAP
  • 10D: 13 L/s exhaust flow with 10 cmH₂O PAP
  • 10E: 8 L/s exhaust flow with 10 cmH₂O PAP Primary endpoint is to evaluate the effect of exhaust flow on flow-adjusted average inspired oxygen fraction (FiO₂) during (1) wakefulness and (2) sleep between 5B vs. 5D.

Eligibility

Inclusion Criteria:

  • Moderate to severe OSA (AHI>20)
  • Self-reported CPAP users or have previously used CPAP
  • Self-reported holding pressure of maximum 13 cmH2O (if known)
  • Age: 21-70
  • BMI: 18-40 kg/m2

Exclusion Criteria:

  • Self-reported severe mouth-breathing
  • Requirement for nocturnal supplemental oxygen or other ventilatory support
  • Severe cardiovascular or pulmonary disease
  • Any unstable or acute medical condition
  • Any additional sleep disorder, including insomnia, except for OSA.

Study details
    Obstructive Sleep Apnea (OSA)

NCT07062770

Brigham and Women's Hospital

19 July 2025

Step 1 Get in touch with the nearest study center
We have submitted the contact information you provided to the research team at {{SITE_NAME}}. A copy of the message has been sent to your email for your records.
Would you like to be notified about other trials? Sign up for Patient Notification Services.
Sign up

Send a message

Enter your contact details to connect with study team

Investigator Avatar

Primary Contact

  Other languages supported:

First name*
Last name*
Email*
Phone number*
Other language

FAQs

Learn more about clinical trials

What is a clinical trial?

A clinical trial is a study designed to test specific interventions or treatments' effectiveness and safety, paving the way for new, innovative healthcare solutions.

Why should I take part in a clinical trial?

Participating in a clinical trial provides early access to potentially effective treatments and directly contributes to the healthcare advancements that benefit us all.

How long does a clinical trial take place?

The duration of clinical trials varies. Some trials last weeks, some years, depending on the phase and intention of the trial.

Do I get compensated for taking part in clinical trials?

Compensation varies per trial. Some offer payment or reimbursement for time and travel, while others may not.

How safe are clinical trials?

Clinical trials follow strict ethical guidelines and protocols to safeguard participants' health. They are closely monitored and safety reviewed regularly.
Add a private note
  • abc Select a piece of text.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.