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In this study, the aerosols emitted during various respiratory activities will be quantified in healthy subjects. The differences in aerosol size spectrum and number during tidal breathing, speaking, coughing and singing will be assessed. Subjects with an endogenously high aerosol emission will repeat the respiratory activities wearing face masks with varying particle filter capacity to investigate the aerosol emission reduction.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Study Part A | No Intervention | Aerosol number and size spectrum characterization of 30 subjects, stratified by age groups, including 10 professional singers. Subjects will be examined twice within 14 days to assess reproducibility of aerosol emission. | |
| Study Part B | Experimental | From the 30 subjects of Part A, the 10 highest-emitting subjects will be assessed a third time, wearing four different classes of face masks consecutively with increasing aerosol filtering capacity. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Community Mask | Other | Fabric mask, no medical device |
| |
| Surgical Mask |
| Measure | Description | Time Frame |
|---|---|---|
| To compare the emitted small particle fraction between various respiratory activities. | Change of particle number per time unit between tidal breathing and various respiratory activities. | Day 1, Day 2 to 14 |
| To assess the influence of different face masks on the emitted small particle fraction of various respiratory activities. | Change of particle number per time unit between tidal breathing and selected respiratory activities for community masks, surgical masks, FFP2 and FFP3 respirators in high-emitting subjects. | After completion of Study part A (approximately 3 months) |
| Measure | Description | Time Frame |
|---|---|---|
| To assess the emitted particle size distribution of various respiratory activities. | Compare changes of emitted particle size spectrum as quantity per size range during tidal breathing and selected respiratory activities. | Day 1, Day 2 to 14 |
| To assess the reproducibility of exhaled particle quantification. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fraunhofer ITEM | Hanover | Lower Saxony | 30625 | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38285475 | Derived | Schwarz K, Struss N, Banari L, Hohlfeld JM. Quantifying Exhaled Particles in Healthy Humans During Various Respiratory Activities Under Realistic Conditions. J Aerosol Med Pulm Drug Deliv. 2024 Apr;37(2):51-63. doi: 10.1089/jamp.2022.0076. Epub 2024 Jan 29. |
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In part A of the study, aerosol emission of subjects will be characterized. From this population, the 10 highest-emitting subjects will enter part B of the study to investigate the effect of face masks on aerosol emission down to the submicron range.
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| Other |
Medical face mask (personal protective equipment), CE-certified |
|
| FFP2 respirator | Other | Filtering Face Piece with no less than 94% filtering capacity, CE-certified |
|
| FFP3 respirator | Other | Filtering Face Piece with no less than 99% filtering capacity, CE-certified |
|
Compare results for particle number per time unit and particle size spectrum from visit 1 and 2. |
| Day 2 to 14 |
| To assess the influence of different face masks on the emitted particle size distribution of various respiratory activities. | Compare changes of emitted particle size spectrum as quantity per size range during tidal breathing and selected respiratory activities for community masks, surgical masks, FFP2 and FFP3 respirators in high-emitting subjects. | After completion of Study part A (approximately 3 months) |