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Biosensor and Environmental Sensor Development Within the REMEDIA Project

NCT06035276 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 25

Last updated 2025-06-26

No results posted yet for this study

Summary

The aim of this proof-of-concept study is to obtain data that will contribute to the development of sensor devices (biosensor and environmental sensor) for patients with lung diseases (e.g. COPD). The study aims to validate our previous results from healthy subjects by joint testing of the biosensor and environmental device in a real-world setting. Healthy subjects and COPD subjects will be exposed to air of a traffic dense urban region ("urban" air) and to filtered indoor air ("clean" air) during activity and rest. Environmental and biomarker sensors will be used to measure several biomarkers and environmental conditions.

Conditions

Interventions

OTHER

Exposure to clean air

Subjects will be exposed to filtered indoor air ("clean" air) for 4 hours in the Fraunhofer Environmental Exposure Chamber. The chamber can accommodate up to 18 subjects, is ventilated by HEPA-filtered and conditioned air, ensuring a constant humidity (40 ± 10%), temperature (22 ± 2°C), and airflow (1500 ± 100 m3/hr). During exposure they will perform an intermittent bicycle ergometer activity at 50 W for 10 minutes alternating with 20 minutes rest.

OTHER

Exposure to urban air

Subjects will be brought to a traffic dense urban region ("urban air") with high traffic density and increased levels of particulate matter and vehicle emissions. Subjects will stay in this area for 4 hours. During exposure, all subjects will walk together with study staff. Rest periods are only allowed outside. Intervals of activity and rest will be similar to the "clean air" regimen.

Sponsors & Collaborators

  • Fraunhofer-Institute of Toxicology and Experimental Medicine

    lead OTHER

Study Design

Allocation
NON_RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
40 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-08-28
Primary Completion
2024-04-19
Completion
2025-04-01

Countries

  • Germany

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06035276 on ClinicalTrials.gov