Actively Recruiting

Phase Not Applicable
Age: 21Years - 70Years
All Genders
ID07062770

Assessment of Circuit Rebreathing During Continuous Positive Airway Pressure (CPAP) Therapy in Obstructive Sleep Apnea

Led by Brigham and Women's Hospital · Updated on 2025-07-14

13

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

Sponsors

B

Brigham and Women's Hospital

Lead Sponsor

S

Sleep Res, Inc.

Collaborating Sponsor

AI-Summary

What this Trial Is About

Researchers are studying how different designs of continuous positive airway pressure (CPAP) masks affect airflow and the rebreathing of exhaled carbon dioxide during sleep in people with obstructive sleep apnea (OSA). This study aims to understand the severity of circuit rebreathing by measuring oxygen and carbon dioxide levels during both wakefulness and sleep. The research focuses on various CPAP settings with different pressure levels and exhaust flow rates to compare their effects. Participants will receive CPAP therapy with varying pressures of 0, 5, or 10 cmH2O and different exhaust port flow rates ranging from 8 to 35 liters per second. The study includes multiple conditions combining these pressures and flow rates to assess their impact on breathing during sleep. The primary comparison is between two specific exhaust flow rates at 5 cmH2O pressure to evaluate oxygen intake levels. During the study, participants will be monitored for changes in the average inspired oxygen fraction both while awake and asleep, along with the hypoxic burden during sleep. These measurements will help determine how CPAP mask designs influence breathing quality. The research will last approximately one year, with continuous monitoring and assessment of breathing parameters to gather detailed information about treatment effects and safety.

CONDITIONS

Brief Title

Assessment of Circuit Rebreathing During CPAP Therapy

Who Can Participate

Age: 21Years - 70Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Moderate to severe obstructive sleep apnea (AHI > 20)
  • Self-reported current or previous use of CPAP therapy
  • Self-reported maximum CPAP pressure of 13 cmH2O or less, if known
  • Age between 21 and 70 years
  • Body mass index (BMI) between 18 and 40 kg/m2
Not Eligible

You will not qualify if you...

  • Severe mouth-breathing
  • Need for supplemental oxygen or other ventilatory support at night
  • Severe cardiovascular or lung disease
  • Any unstable or acute medical condition
  • Any other sleep disorder besides obstructive sleep apnea, including insomnia

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

Implementation

Duration - Up to 1 year

Participants use continuous positive airway pressure (CPAP) therapy with varying mask exhaust port flows to assess circuit rebreathing during wakefulness and sleep.

Visits scheduled to monitor effects during different CPAP and exhaust flow settings

Trial Site Locations

Total: 1 location

1

Brigham and Women's Hospital

Boston, Massachusetts, United States, 02115

Actively Recruiting

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Research Team

A

Atqiya Aishah, PhD

S

Scott A Sands, PhD

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

SEQUENTIAL

Primary Purpose

OTHER

Number of Arms

11

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