Actively Recruiting
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
Eligibility Criteria
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
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
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
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
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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