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| Name | Class |
|---|---|
| Sleep Res, Inc. | UNKNOWN |
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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).
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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 5 cmH2O with 35L/s | Experimental | 35 L/s exhaust flow with 5 cmH₂O PAP |
|
| 5 cmH2O with 23L/s | Experimental | 23 L/s exhaust flow with 5 cmH₂O PAP |
|
| 5 cmH2O with 18L/s | Experimental | 18 L/s exhaust flow with 5 cmH₂O PAP |
|
| 5 cmH2O with 13L/s | Experimental | 13 L/s exhaust flow with 5 cmH₂O PAP |
|
| 5 cmH2O with 8L/s | Experimental | 8 L/s exhaust flow with 5 cmH₂O PAP |
|
| 0 cmH2O with 35L/s |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Continuous positive airway pressure (CPAP) | Device | Subjects will be administered either 0, 5 or 10 cmH2O |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in flow-adjusted average inspired oxygen fraction (FiO₂) during wake. | Difference in FiO2 between 23L/s vs 13L/s exhaust flow at 5 cmH2O PAP. | through study completion, an average of 1 year |
| Change in flow-adjusted average inspired oxygen fraction (FiO₂) during sleep. | Difference in FiO2 between 23L/s vs 13L/s exhaust flow at 5 cmH2O PAP. | through study completion, an average of 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Impact on hypoxic burden during sleep. | Difference in hyboxic burden between 23L/s vs 13L/s exhaust flow at 5 cmH2O PAP. | through study completion, an average of 1 year |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Atqiya Aishah, PhD | Contact | 857 396 3808 | aaishah@bwh.harvard.edu | |
| Scott A Sands, PhD | Contact | 6172780911 | sasands@bwh.harvard.edu |
| Name | Affiliation | Role |
|---|---|---|
| Atqiya Aishah, PhD | Harvard Medical School & Brigham and Women's Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Brigham and Women's Hospital | Recruiting | Boston | Massachusetts | 02115 | United States |
Deidentified subject data will be available upon request.
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| ID | Term |
|---|---|
| D020181 | Sleep Apnea, Obstructive |
| ID | Term |
|---|---|
| D012891 | Sleep Apnea Syndromes |
| D001049 | Apnea |
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| D045422 | Continuous Positive Airway Pressure |
| ID | Term |
|---|---|
| D011175 | Positive-Pressure Respiration |
| D012121 | Respiration, Artificial |
| D058109 | Airway Management |
| D013812 | Therapeutics |
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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.
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The exhaust flow and PAP level conditions will be blinded for the participant.
| Placebo Comparator |
35 L/s exhaust flow with 0 cmH₂O PAP |
|
| 10 cmH2O with 35L/s | Experimental | 35 L/s exhaust flow with 10 cmH₂O PAP |
|
| 10 cmH2O with 23L/s | Experimental | 23 L/s exhaust flow with 10 cmH₂O PAP |
|
| 10 cmH2O with 18L/s | Experimental | 18 L/s exhaust flow with 10 cmH₂O PAP |
|
| 10 cmH2O with 13L/s | Experimental | 13 L/s exhaust flow with 10 cmH₂O PAP |
|
| 10 cmH2O with 8L/s | Experimental | 8 L/s exhaust flow with 10 cmH₂O PAP |
|
| Mask exhaust port flow | Other | Subjects will be administered varying levels of exhaust flow: 35, 23, 18, 13 and 8 L/s |
|
| D020919 |
| Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
| D012138 |
| Respiratory Therapy |