Effect of Air Pollution on the Cognitive Function of Adolescents (ATENC!Ó)

August 6, 2019 updated by: Barcelona Institute for Global Health

Citizen Science for Analysing the Effect of Air Pollution on the Cognitive Function of Adolescents

Previous observational studies have reported an association between higher air pollution exposure and lower attention in children. With this project, the investigators aim to confirm this association in adolescents using an experimental design. In addition, the study will assess the relationship between air pollution exposure and individual preferences with respect to risk, time and social considerations. High school students in 3rd grade (ESO, 14-15 years of age) in different high schools in the Barcelona province (Spain) will be invited to participate. For each class in each high school, participating students will be randomly split into two equal-sized groups. Each group will be assigned to a different classroom where they will complete several activities during two hours, including an attention test (Flanker task) and a reduced version of the Global Preferences Survey. One of the classrooms will have an air purifier that will clean the air. The other classroom will have the same device but without the filters, so it will only re-circulate the air without cleaning it. Students will be masked to intervention allocation. The investigators hypothesize that students assigned to the clean air classroom will have better scores in the attention test, and that decision-making will also present differences in the two classrooms.

Study Overview

Study Type

Interventional

Enrollment (Actual)

2123

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Barcelona, Spain, 08003
        • ISGlobal

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

13 years to 16 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Students in the 3rd ESO course in participating high schools with signed informed consent

Exclusion Criteria:

  • None

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Purified air
Purifying the air with a Pure Airbox device (Zonair 3D). Use of air purifier (Pure Airbox, Zonair 3D) in the classroom 30 minutes before the participants enter the room and during the 2 hours of the experiment.
Purifying the air of the classroom where the experiment is conducted using a Pure Airbox device (Zonair 3D)
Other Names:
  • Air filtering
  • Air cleaning
Sham Comparator: Normal air
Using a sham air purifier (same device without filters). Use of the same air purifier but without filters, so that it only recirculates the air without purifying it. Used for the same time period than the other arm.
Use the air purifier (Pure Airbox, Zonair 3D) without filters in the classroom where the experiment is conducted
Other Names:
  • Sham air cleaner

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Response speed consistency throughout the Attention Network Task-Flanker Task (post ANT)
Time Frame: Obtained from a test administered approximately 90 minutes after entering the classroom
Calculated as hit reaction time standard error for correct responses (HRT-SE). A higher HRT-SE indicates highly variable reactions related to inattentiveness
Obtained from a test administered approximately 90 minutes after entering the classroom
Combined risk taking score
Time Frame: Obtained from a test administered approximately 100 minutes after entering the classroom
Risk taking = 0.4729985 × "Risk preference score" + 0.5270015 × "Willingness to take risks", that follows the parameters of Falk et al (2018), where the "Risk preference score" is the final node in the risk tree (see the online appendix of Falk et al (2018)), which is a value between 1 and 32, ranked by the level of risk aversion, and the "Willingness to take risks" refers to the answer to the question on one's willingness to take risks.
Obtained from a test administered approximately 100 minutes after entering the classroom
Combined patience score
Time Frame: Obtained from a test administered approximately 100 minutes after entering the classroom
Patience = 0.7115185 × "Time preference score" + 0.2884815 × "Self assessment of patience", that follows the parameters of Falk et al (2018), where the "Time preference score" is the final node in the time tree (see the online appendix of Falk et al (2018)), which is a value between 1 and 32, ranked by the level of patience, and the "Self assessment of patience" refers to the answer to the question on the self-assessment of patience (willingness to give up something today).
Obtained from a test administered approximately 100 minutes after entering the classroom
Positive reciprocity score
Time Frame: Obtained from a test administered approximately 100 minutes after entering the classroom
Positive reciprocity = 0.4847038 × "Willingness to return favor" + 0.5152962 × "Size of gift", that follows the parameters of Falk et al (2018), where "Willingness to return favor" refers to the answer to the question on the willingness to return a favor, and "Size of gift" refers to the answer to the question on the reported size of the gift that would return to a stranger.
Obtained from a test administered approximately 100 minutes after entering the classroom
Altruism score
Time Frame: Obtained from a test administered approximately 100 minutes after entering the classroom
Altruism = 0.6350048 × "Willingness to give to good causes" + 0.3649952 × "Hypothetical donation", that follows the parameters of Falk et al (2018), where "Willingness to give to good causes" refers to the answer to the question on the willingness to give to good causes, and "Hypothetical donation" refers to the answer to the question on the size of the hypothetical donation one would be willing to make.
Obtained from a test administered approximately 100 minutes after entering the classroom
Trust score
Time Frame: Obtained from a test administered approximately 100 minutes after entering the classroom
Answer to the question "I assume that people have only the best intentions".
Obtained from a test administered approximately 100 minutes after entering the classroom

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Impulsivity (from ANT)
Time Frame: Obtained from a test administered approximately 90 minutes after entering the classroom
Number of incorrect responses (responses made in the opposite direction to the direction of the target arrow)
Obtained from a test administered approximately 90 minutes after entering the classroom
Selective attention (from ANT)
Time Frame: Obtained from a test administered approximately 90 minutes after entering the classroom
Number of omission errors (failure to respond)
Obtained from a test administered approximately 90 minutes after entering the classroom
Alerting score (from ANT)
Time Frame: Obtained from a test administered approximately 90 minutes after entering the classroom
Subtracting the median RT for double cue from median RT for the no cue condition (calculations performed after removing the incongruent trials)
Obtained from a test administered approximately 90 minutes after entering the classroom
Orienting score (from ANT)
Time Frame: Obtained from a test administered approximately 90 minutes after entering the classroom
Subtracting the median RT for spatial cue from the RT for central cue (calculations performed after removing the incongruent trials)
Obtained from a test administered approximately 90 minutes after entering the classroom
Conflict score (executive attention) (from ANT)
Time Frame: Obtained from a test administered approximately 90 minutes after entering the classroom
Participant's median RT for each flanker condition (across cue conditions) and subtracted the congruent from the incongruent RTs
Obtained from a test administered approximately 90 minutes after entering the classroom
Self assessment of how good they are in math
Time Frame: Obtained from a test administered approximately 100 minutes after entering the classroom
Answer to the question on how good they are in math.
Obtained from a test administered approximately 100 minutes after entering the classroom

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 23, 2018

Primary Completion (Actual)

June 11, 2019

Study Completion (Actual)

June 11, 2019

Study Registration Dates

First Submitted

November 23, 2018

First Submitted That Met QC Criteria

November 30, 2018

First Posted (Actual)

December 3, 2018

Study Record Updates

Last Update Posted (Actual)

August 7, 2019

Last Update Submitted That Met QC Criteria

August 6, 2019

Last Verified

August 1, 2019

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Plan Description

All collected IPD except identifying information for participants or high schools will be shared

IPD Sharing Time Frame

Data will become available when publishing the results in a scientific journal, with no time restrictions

IPD Sharing Access Criteria

Access to anyone via a public repository

IPD Sharing Supporting Information Type

  • Study Protocol
  • Statistical Analysis Plan (SAP)
  • Analytic Code

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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