Healthy
Conditions
Keywords
Aerosols, Exhaled particles, Face mask
Brief summary
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.
Interventions
OTHERCommunity Mask
Fabric mask, no medical device
OTHERSurgical Mask
Medical face mask (personal protective equipment), CE-certified
OTHERFFP2 respirator
Filtering Face Piece with no less than 94% filtering capacity, CE-certified
OTHERFFP3 respirator
Filtering Face Piece with no less than 99% filtering capacity, CE-certified
Sponsors
Fraunhofer-Institute of Toxicology and Experimental Medicine
Study design
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
BASIC_SCIENCE
Masking
NONE
Intervention model description
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
Yes
Inclusion criteria
1. Able and willing to give written informed consent. 2. Healthy male and female subjects, aged 18-80 years. 3. Body mass index between 18 and 35 kg/m2. 4. FEV1 ≥ 80% predicted.
Exclusion criteria
1. Any clinically relevant abnormal findings in physical examination or lung function at screening visit, which, in the opinion of the investigator, may either put the subject at risk because of participation in the study or may influence the results of the study, or the subject's ability to participate in the study. 2. Risk of non-compliance with study procedures. 3. Suspected inability to understand the protocol requirements, instructions and study-related restrictions, the nature, scope, and possible consequences of the study. 4. History of an acute respiratory infection with symptoms such as cough, rhinitis, sore throat, hoarseness or fever, within four weeks prior to the informed consent visit. In case of acute respiratory infection during study participation, the visit may be rescheduled within the allowed time window. Subjects must be asymptomatic for at least 3 days. Re-screening is allowed should the time window be exceeded. 5. History of lung disease including but not confined to COPD, asthma or pulmonary fibrosis. 6. History of latex allergy.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| To compare the emitted small particle fraction between various respiratory activities. | Day 1, Day 2 to 14 | Change of particle number per time unit between tidal breathing and various respiratory activities. |
| To assess the influence of different face masks on the emitted small particle fraction of various respiratory activities. | After completion of Study part A (approximately 3 months) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| To assess the emitted particle size distribution of various respiratory activities. | Day 1, Day 2 to 14 | Compare changes of emitted particle size spectrum as quantity per size range during tidal breathing and selected respiratory activities. |
| To assess the reproducibility of exhaled particle quantification. | Day 2 to 14 | Compare results for particle number per time unit and particle size spectrum from visit 1 and 2. |
| To assess the influence of different face masks on the emitted particle size distribution of various respiratory activities. | After completion of Study part A (approximately 3 months) | 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. |
Countries
Germany
Outcome results
None listed