NCT05105386

Brief Summary

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.

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
3,000

participants targeted

Target at P75+ for all trials

Timeline
16mo left

Started Sep 2023

Longer than P75 for all trials

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress67%
Sep 2023Sep 2027

First Submitted

Initial submission to the registry

September 13, 2021

Completed
2 months until next milestone

First Posted

Study publicly available on registry

November 3, 2021

Completed
1.8 years until next milestone

Study Start

First participant enrolled

September 1, 2023

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2027

Expected
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2027

Last Updated

November 3, 2021

Status Verified

October 1, 2021

Enrollment Period

3.5 years

First QC Date

September 13, 2021

Last Update Submit

October 22, 2021

Conditions

Outcome Measures

Primary Outcomes (8)

  • Respiratory, mental health

    Questionnaires

    One year

  • Immune health

    RNA Sequency/CRP

    One year

  • Oxidative stress

    DNA damage levels in blood cells

    One year

  • Lung function and

    Spirometry

    One year

  • Airway inflammation

    Exhaled nitric oxide

    One year

  • Exhaled volatile compounds

    Breath biopsy

    One year

  • Cardiovascular metrics

    Wearables

    One year

  • Height and weight

    Height in cm and weight in kg will be combined to report BMI (kg/m\^2)

    One year

Interventions

Monitor the indoor pollutants and their effect on children well being

Eligibility Criteria

Age8 Years - 9 Years
Sexall
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

Children at this age have the ability to understand the character of the study, to handle the app and the wearables, to successfully perform lung function and airway inflammation measurements (as it has been ascertained in the previous FP7\_PreDicta and Horizon\_CURE projects), to cooperate with blood sampling, while not being yet subjective to hormonal changes of puberty. Moreover, students at this age mainly attend lessons in the same class, thus exposures in the school environment are considered stable,

You may qualify if:

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

You may not qualify if:

  • Unwilling to use the application and follow the procedures of the protocol

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood samples (optional)

Study Officials

  • NIKOLAOS G PAPADOPOULOS, Professor

    National and Kapodistrian Univeristy of Athens

    STUDY CHAIR

Central Study Contacts

PARASKEVI XEPAPADAKI, Assoc. Prof.

CONTACT

NIKOLAOS G PAPADOPOULOS, Professor

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
1 Year
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PROFESSOR

Study Record Dates

First Submitted

September 13, 2021

First Posted

November 3, 2021

Study Start

September 1, 2023

Primary Completion (Estimated)

March 1, 2027

Study Completion (Estimated)

September 1, 2027

Last Updated

November 3, 2021

Record last verified: 2021-10