What effects does the continuous wearing of an oral-nasal covering have on the homeostasis of healthy children compared to healthy adults?

What effects does the continuous wearing of an oral-nasal covering have on the homeostasis of healthy children compared to healthy adults? - MVK

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

DRKS

Registry ID

DRKS00024880

Enrollment

Registered

2021-04-12

Start date

2021-03-10

Completion date

Unknown

Last updated

2025-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

R06.88

Interventions

Group 1: Men 18 years and older without chronic diseases 1st appointment: Perleberg Clinic: wearing a fabric mask for 4 hours, including a maximum of 30 minutes of breaks. Determination of blood gas

Eligibility

Sex/Gender

All

Age

6 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1. healthy (no known chronic diseases, no abnormal medical history, and no acute diseases in the last 2 weeks, current lung function unremarkable). 2. targeted minimum pilot sample size of 40 persons with complete data 3. signature of informed consent from guardians and minors 4. Covid-19-AG rapid test inconspicuous

Exclusion criteria

Exclusion criteria: 1. inclusion criteria not met 2. pregnancy 3. drug abuse 4. condition following severe craniocerebral trauma 5. minors, without a guardian or authorised supervisor 6. small children (< 6 years), as they are currently not obliged to wear a mask 7. older adolescents (over 16 years of age), as their physiology is likely to be similar to that of adults 8. abnormal ECG findings during the monitoring of vital signs will lead to study termination. Such subjects will receive the urgent recommendation to have the findings in question medically clarified.

Design outcomes

Primary

Measure	Time frame
The primary aim of our study is to determine mask tolerance and the impact of mask use on the homeostasis of healthy children compared to healthy adults. Our study aims to initiate dialogue, provide reassurance about the risk distribution of potential adverse events and possible long-term harm, and build trust in each other. It can support medical professionals in counselling uncertain parents to increase their compliance and give them confidence in using the different types of masks. At the same time, critical results must be taken into account by the medical associations in their statements. The primary endpoint is complete participation in each of the 7 appointments for intraindividual comparison as well as for comparison of the individual groups. The clinical part of the study includes 3 appointments on site, at the Prignitz Clinic. A venous blood sample will be obtained for analysis during the 4 hours of wear over 4.5 hours initially (control), after 30 minutes and then at 60-minute intervals. Peripheral venous access was established at the beginning of the study day. The blood gas analyser is from Abbott, the i-STAT Alinity Analyser with the i-STAT Alinity Printer. In the same rhythm, complaints are asked and the vital parameters respiratory rate, oxygen saturation and blood pressure are determined via HVR councils from the company Nihon Kohden and documented in a prefabricated protocol. The entry of the values and the complaints is not done independently, but is taken over by the caring staff. The home part of the study includes 4 appointments at home. The test persons are informed to organise stress-free days if possible. Detailed instructions as well as a material package are handed out to the test person. At each appointment, the 24-hour urine is collected from the volunteer and 4 saliva samples are obtained at 4 set times during the day. These samples are delivered by courier service to the Brandenburg an der Havel laboratory, Brandenburg, where they	—

Measure

Time frame

The primary aim of our study is to determine mask tolerance and the impact of mask use on the homeostasis of healthy children compared to healthy adults. Our study aims to initiate dialogue, provide reassurance about the risk distribution of potential adverse events and possible long-term harm, and build trust in each other. It can support medical professionals in counselling uncertain parents to increase their compliance and give them confidence in using the different types of masks. At the same time, critical results must be taken into account by the medical associations in their statements. The primary endpoint is complete participation in each of the 7 appointments for intraindividual comparison as well as for comparison of the individual groups. The clinical part of the study includes 3 appointments on site, at the Prignitz Clinic. A venous blood sample will be obtained for analysis during the 4 hours of wear over 4.5 hours initially (control), after 30 minutes and then at 60-minute intervals. Peripheral venous access was established at the beginning of the study day. The blood gas analyser is from Abbott, the i-STAT Alinity Analyser with the i-STAT Alinity Printer. In the same rhythm, complaints are asked and the vital parameters respiratory rate, oxygen saturation and blood pressure are determined via HVR councils from the company Nihon Kohden and documented in a prefabricated protocol. The entry of the values and the complaints is not done independently, but is taken over by the caring staff. The home part of the study includes 4 appointments at home. The test persons are informed to organise stress-free days if possible. Detailed instructions as well as a material package are handed out to the test person. At each appointment, the 24-hour urine is collected from the volunteer and 4 saliva samples are obtained at 4 set times during the day. These samples are delivered by courier service to the Brandenburg an der Havel laboratory, Brandenburg, where they

—

Secondary

Measure	Time frame
We want to contribute to the creation of the scientific basis for mask-wearing in children. There are also many open research questions on this topic: Therefore, in later studies, symptomatic patients without underlying diseases as well as chronically ill people should be included in a differentiated manner during mask-wearing. They are most likely to have much more sensitive homeostasis regimes and are more at risk for critical changes. A realistic approach including the current everyday stress factors at school (due to the implementation of hygiene measures in the context of mandatory masks, temperatures perceived as stressful, air quality, light conditions, lack of physical activities as well as emotional stress due to friendships, quarrels or failures) may also yield new revealing findings. The material and chemical composition of the different types of masks should be urgently examined from the point of view of tolerance, possible disease-causing or carcinogenic compounds. Possible relevant microbial contamination on the masks with health consequences and/or the occurrence of cognitive restrictions, for example concerning the learning effect and socialisation, is certainly to be expected and should be examined more closely in further studies. These follow-up studies have already been initiated in part by our team and thus correspond to the secondary objective criteria of our pilot study.	—

Measure

Time frame

We want to contribute to the creation of the scientific basis for mask-wearing in children. There are also many open research questions on this topic: Therefore, in later studies, symptomatic patients without underlying diseases as well as chronically ill people should be included in a differentiated manner during mask-wearing. They are most likely to have much more sensitive homeostasis regimes and are more at risk for critical changes. A realistic approach including the current everyday stress factors at school (due to the implementation of hygiene measures in the context of mandatory masks, temperatures perceived as stressful, air quality, light conditions, lack of physical activities as well as emotional stress due to friendships, quarrels or failures) may also yield new revealing findings. The material and chemical composition of the different types of masks should be urgently examined from the point of view of tolerance, possible disease-causing or carcinogenic compounds. Possible relevant microbial contamination on the masks with health consequences and/or the occurrence of cognitive restrictions, for example concerning the learning effect and socialisation, is certainly to be expected and should be examined more closely in further studies. These follow-up studies have already been initiated in part by our team and thus correspond to the secondary objective criteria of our pilot study.

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Countries

Germany

Contacts

Public ContactKarin Böhm

Kreiskrankenhaus Prignitz gGmbH, Klinik für Kinder- und Jugendmedizin

k.boehm@krankenhaus-prignitz.de03876-303181

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026