MedDataX Logo

The Impact of Synergies of Indoor Air Pollutants on Childhood Health and Wellbeing

NCT ID: NCT05105386

Last Updated: 2021-11-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

NOT_YET_RECRUITING

Total Enrollment

3000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-09-30

Study Completion Date

2027-09-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

To quantify health effects of synergizing chemical and biological pollutants in a targeted population setting, i.e., school-aged children. Indoor air pollutants will be monitored within the classrooms with high end sensors. Exposure data from additional sources (outdoor, home, transports) will be obtained. Health outcomes will be assessed prospectively using validated medical procedures and real-time tracking with mobile health (mHealth) equipment and a gamified computer app.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Communication with individual schools and families representing diverse cultural and socioeconomic backgrounds, will be conducted and formal participation consents obtained. The target population will include healthy children and be enriched for children with respiratory allergies and asthma. Provision of instructions, training for participation and baseline assessments of respiratory, immune, and mental health using questionnaires and relevant physiological measurements (e.g spirometry, FeNO), will be performed. Sensors will be positioned and cross-checked for functionality.Health data from the cohort will be monitored by a specifically designed gamified application, as well as by state-of-the-art wearable tracking technology. The app will capture input from the participants at large, while the trackers will accurately, continuously, and remotely, identify personalized patterns of all day activity status, heart rate, oxygen saturation, temperature, blood pressure, sleep, respiratory rate, and mechano-acoustic breathing sounds signatures. Sentinel data will be processed in Work Package 6 and integrated in the SynAir-G autonomous sensing platform.

Children will be prospectively followed-up for a school year. Investigators will regularly visit schools to keep sensors running and collect materials. Real-time tracking will be coupled with regular communication and face-to-face visits for health outcome assessments. Devices will be positioned in selected locations. The cohort will also provide the setting for establishing indoor and outdoor interactions, dose-responses in real life, and health outcome data for integration and synergy analyses.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Pollution; Exposure Environmental Exposure Childhood Asthma Childhood

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

SynAir-Child

Monitor the indoor pollutants and their effect on children well being

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

1. Students of primary schools aged 8-9 years.
2. The subject and/or legal custodian have the verbal, writing and mental ability to understand the intent and character of the study.
3. Written informed consent from the child's parents/guardian's

Exclusion Criteria

Unwilling to use the application and follow the procedures of the protocol
Minimum Eligible Age

8 Years

Maximum Eligible Age

9 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

National and Kapodistrian University of Athens

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

NIKOLAOS G. PAPADOPOULOS

PROFESSOR

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

NIKOLAOS G PAPADOPOULOS, Professor

Role: STUDY_CHAIR

National and Kapodistrian Univeristy of Athens

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

PARASKEVI XEPAPADAKI, Assoc. Prof.

Role: CONTACT

Phone: 2132009160

Email: [email protected]

NIKOLAOS G PAPADOPOULOS, Professor

Role: CONTACT

Phone: 2107776964

Email: [email protected]

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

SEP-210769726

Identifier Type: -

Identifier Source: org_study_id