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NCT Number: NCT07062770

Assessment of Circuit Rebreathing During CPAP Therapy

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).

Recruiting

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Key information

Age range

21 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Continuous Positive Airway Pressure (CPAP)

Device

Subjects will be administered either 0, 5 or 10 cmH2O

Mask exhaust port flow

Other

Subjects will be administered varying levels of exhaust flow: 35, 23, 18, 13 and 8 L/s

Primary outcomes

  1. Change in flow-adjusted average inspired oxygen fraction (FiO₂) during wake.

    Time frame: through study completion, an average of 1 year

    Difference in FiO2 between 23L/s vs 13L/s exhaust flow at 5 cmH2O PAP.

  2. Change in flow-adjusted average inspired oxygen fraction (FiO₂) during sleep.

    Time frame: through study completion, an average of 1 year

    Difference in FiO2 between 23L/s vs 13L/s exhaust flow at 5 cmH2O PAP.

Secondary outcomes

  1. Impact on hypoxic burden during sleep.

    Time frame: through study completion, an average of 1 year

    Difference in hyboxic burden between 23L/s vs 13L/s exhaust flow at 5 cmH2O PAP.

Study contacts

Contact information is provided by the study sponsor or research team.

Atqiya Aishah, PhD

CONTACT

[email protected]

857 396 3808

Scott A Sands, PhD

CONTACT

[email protected]

6172780911

Sponsors and collaborators

Lead sponsor

Brigham and Women's Hospital

Other

Collaborators

  • Sleep Res, Inc.

Registry information

Official study title

Assessment of Circuit Rebreathing During Continuous Positive Airway Pressure (CPAP) Therapy

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Jul 14, 2025
Registry last updated
Jul 14, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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