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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03762239
Other study ID # PI2030
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date November 23, 2018
Est. completion date June 11, 2019

Study information

Verified date August 2019
Source Barcelona Institute for Global Health
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Recruitment information / eligibility

Status Completed
Enrollment 2123
Est. completion date June 11, 2019
Est. primary completion date June 11, 2019
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 13 Years to 16 Years
Eligibility Inclusion Criteria:

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

Exclusion Criteria:

- None

Study Design


Intervention

Other:
Purifying the air with a Pure Airbox device (Zonair 3D)
Purifying the air of the classroom where the experiment is conducted using a Pure Airbox device (Zonair 3D)
Using a sham air purifier (same device without filters)
Use the air purifier (Pure Airbox, Zonair 3D) without filters in the classroom where the experiment is conducted

Locations

Country Name City State
Spain ISGlobal Barcelona

Sponsors (5)

Lead Sponsor Collaborator
Barcelona Institute for Global Health Centre de Recerca per a l'Educació Científica i Matemàtica (CRECIM), Economics and Bussiness Department, Universtitat Pompeu Fabra, Institute of Environmental Assessment and Water Research (IDAEA-CSIC), Recercaixa

Country where clinical trial is conducted

Spain, 

Outcome

Type Measure Description Time frame Safety issue
Primary Response speed consistency throughout the Attention Network Task-Flanker Task (post ANT) 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
Primary Combined risk taking score 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
Primary Combined patience score 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
Primary Positive reciprocity score 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
Primary Altruism score 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
Primary Trust score 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 Impulsivity (from ANT) 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
Secondary Selective attention (from ANT) Number of omission errors (failure to respond) Obtained from a test administered approximately 90 minutes after entering the classroom
Secondary Alerting score (from ANT) 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
Secondary Orienting score (from ANT) 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
Secondary Conflict score (executive attention) (from ANT) 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
Secondary Self assessment of how good they are in math Answer to the question on how good they are in math. Obtained from a test administered approximately 100 minutes after entering the classroom
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