Obstructive Sleep Apnea (OSA)
Conditions
Keywords
Obstructive sleep apnea
Brief summary
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).
Detailed 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.
Interventions
DEVICEContinuous positive airway pressure (CPAP)
Subjects will be administered either 0, 5 or 10 cmH2O
OTHERMask exhaust port flow
Subjects will be administered varying levels of exhaust flow: 35, 23, 18, 13 and 8 L/s
Sponsors
Sleep Res, Inc.
Brigham and Women's Hospital
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
OTHER
Masking
SINGLE (Subject)
Masking description
The exhaust flow and PAP level conditions will be blinded for the participant.
Intervention model description
Subjects will perform 1 in-lab sleep study visit consisting of an evening wake session followed by an overnight sleep study. Subjects will receive randomized sequences of 11 conditions (varying in exhaust flow and PAP levels) during the evening and sleep portions of the night.
Eligibility
Sex/Gender
ALL
Age
21 Years to 70 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in flow-adjusted average inspired oxygen fraction (FiO₂) during wake. | through study completion, an average of 1 year | Difference in FiO2 between 23L/s vs 13L/s exhaust flow at 5 cmH2O PAP. |
| Change in flow-adjusted average inspired oxygen fraction (FiO₂) during sleep. | through study completion, an average of 1 year | Difference in FiO2 between 23L/s vs 13L/s exhaust flow at 5 cmH2O PAP. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Impact on hypoxic burden during sleep. | through study completion, an average of 1 year | Difference in hyboxic burden between 23L/s vs 13L/s exhaust flow at 5 cmH2O PAP. |
Countries
United States
Contacts
Primary ContactAtqiya Aishah, PhD
Backup ContactScott A Sands, PhD
Outcome results
None listed