Improving indoor air quality for a healthier home and Europe

ISRCTN ISRCTN65002425
DOI https://doi.org/10.1186/ISRCTN65002425
Secondary identifying numbers 101057499
Submission date
27/02/2023
Registration date
21/03/2023
Last edited
31/05/2024
Recruitment status
No longer recruiting
Overall study status
Ongoing
Condition category
Other
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year

Plain English Summary

Background and study aims
Most research into pollution and health has focused on outdoor air pollution. Although about 90% of our time is spent in indoor environments such as our homes, we know very little about indoor air pollution and how it affects our health. We don’t know what factors cause indoor air pollution to be higher, or how best to reduce indoor pollution levels. The main goal of this study is the protection of citizen health by providing knowledge and tools to substantially improve indoor air quality. The researchers will conduct research and evaluate actions to reduce harmful exposures in homes and positively impact the health of residents. The study aims to look at patterns of indoor air pollution in homes and identify the main factors that drive indoor air pollution. Based on this assessment, the researchers will develop and test strategies to improve indoor air quality and lower the burden of chemical exposures that children and adults receive inside the home. This study will provide information to policymakers and regulators to allow informed and effective decisions towards the protection of citizens’ health.

Who can participate?
Families across eight countries (Czechia, Estonia, Italy, Netherlands, Portugal, Slovenia, Sweden and the United Kingdom) with at least one child under 5 years of age

What does the study involve?
The study involves allowing research team members to install small, non-disruptive samplers of indoor air and dust in the living room of a home, and providing a urine sample to determine exposures to chemicals frequently found in household products and materials, indoor air and dust.

What are the possible benefits and risks of participating?
There is no risk to participating. Participants can benefit by opting to receive information about the indoor air quality in their homes and suggested actions to improve indoor air quality and reduce the burden of chemical exposure.

Where is the study run from?
NILU - Norwegian Institute for Air Research (Norway)

When is the study starting and how long is it expected to run for?
September 2022 to August 2027

Who is funding the study?
1. Horizon Europe (UK)
2. UK Research and Innovation (UK)

Who is the main contact?
NILU - Norwegian Institute for Air Research, inquire@nilu.no

Study website

Contact information

Dr Pernilla Bohlin-Nizzetto
Principal Investigator

Norsk institutt for luftforskning - NILU
PO Box 100
Kjeller
2027
Norway

ORCiD logoORCID ID 0000-0003-2835-8509
Phone +47 (0)63 89 80 89
Email pbn@nilu.no
Dr Maja Nipen
Public

Norsk institutt for luftforskning - NILU
PO Box 100
Kjeller
2027
Norway

ORCiD logoORCID ID 0000-0002-5157-435X
Phone +47 (0)63 89 81 74
Email mni@nilu.no
Dr Pawel Rostkowski
Public

Norsk institutt for luftforskning - NILU
PO Box 100
Kjeller
2027
Norway

ORCiD logoORCID ID 0000-0001-9778-4283
Phone +47 (0)63 89 80 52
Email pr@nilu.no
Dr Lisa Melymuk
Scientific

RECETOX
Masaryk University
Kamenice 753/5, pavilion D29
Brno
62500
Czech Republic

ORCiD logoORCID ID 0000-0001-6042-7688
Phone +420 (0)549 49 3995
Email lisa.melymuk@recetox.muni.cz
Dr Chiara Giorio
Scientific

Yusuf Hamied Department of Chemistry
University of Cambridge
Lensfield Road
Cambridge
CB2 1EW
United Kingdom

ORCiD logoORCID ID 0000-0001-7821-7398
Phone +44 1223 336392
Email cg525@cam.ac.uk

Study information

Study designPhase 1: observational cross-sectional study; Phase 2: observational case-crossover study
Primary study designObservational
Secondary study designCase crossover study
Study setting(s)Home
Study typeOther
Participant information sheet Not available in web format, please use contact details to request a participant information sheet
Scientific titleINQUIRE: Identification of chemical and biological determinants, their sources, and strategies to promote healthier homes in Europe
Study acronymINQUIRE
Study hypothesisGuidelines on indoor air quality (IAQ) are intended to prevent health risks from indoor exposure. WHO’s guidelines on biological and chemical pollution include dampness, mould, benzene, carbon monoxide (CO), formaldehyde, nitrogen dioxide (NO2), naphthalene, polycyclic aromatic hydrocarbons (PAHs), radon and tetra- and tri-chloroethylene. However, there is an evidence-based consensus that the determinants of IAQ are more numerous and complex than these few single-exposure IAQ parameters. More than 350,000 chemicals are in global commerce today (>100,000 in the EU), many with a complex array of degradation products, which must also be considered when assessing exposure and risk. Many other unknown or poorly characterized chemicals enter the European market unchecked in imported commercial products and household materials (despite the current chemical management regulation). It is evident that humans are ubiquitously and increasingly exposed to such man-made chemicals, especially indoors where materials such as building materials, furniture, electronics, personal care products, cleaning products, and toys contain man-made chemicals, often not chemically bound to the solid matrix, that can be released to indoor air and particles. There is however, in the EU, as elsewhere, a poor understanding of chemicals in indoor-related products, including building materials and consumer products. In addition to chemicals, also microbial communities in the built environments may affect human health. Some studies suggest that the indoor microbiome may elicit negative health effects, but recent findings provide strong evidence that the indoor microbiome may also reduce the risk of asthma and allergies, possibly by promoting the development of immune tolerance. There is a consensus that the identity and risk posed by this multitude of (mostly unknown) substances released into indoor air is the tip of the iceberg of indoor environmental quality. INQUIRE’s ambition is to enable the effective protection of citizens of Europe (and in particular children) from both currently prioritized chemical and biological hazards present in household air, as well as from yet undetected and/or overlooked pollutants. INQUIRE will achieve this by extending inventories of these pollutants, advancing knowledge on their sources, a better understanding of their importance for human health, providing new assessment techniques for exposure and health risk and proposing a series of interventions to improve IAQ and reduce exposure to hazards in the home.
Ethics approval(s)Ethics approval are distributed across eight sampling regions through local ethics boards:
1. Czechia (Responsible partner: Masaryk University) - CELSPAC ethics committee (Masaryk University, Kamenice 753/5, pavilion D29, 625 00 Brno, Czech Republic; +420 (0)549493079; andryskova@recetox.muni.cz), ref: (C)ELSPAC/EK/3/2023
2. Estonia (Responsible partner: Health Board Terviseamet) - Research Ethics Committee of the National Institute for Health Development (Hiiu 42, Tallinn 11619, Estonia; +372 (0)659 3924; eetikakomitee@tai.ee), ref: 380/T-1
3. Italy. Approved 02/05/2023, (Responsible partner: Istituto Superiore di Sanità (ISS)) - National Ethics Committee for Clinical Trials of Public Research Bodies and Other National Public Institutions (CEN) (299, Viale Regina Elena, 00161, Roma, Italy; +39 (0)6 4990 4288; segreteria.comitatoetico@iss.it), ref: 0020314
4. Netherlands (Responsible partner: Vrije Universiteit Amsterdam) - BETHCIE, Research Ethics Review Committee, Faculty of Science (bethcie.beta@vu.nl), ref: 28-008
5. Portugal (Responsible partner: Institute of Science and Innovation in Mechanical and Industrial Engineering (INEGI)) - Ethics Committee of the University of Porto (CEUP, Praça Gomes Teixeira Porto, Portugal; +351 (0)4099 002), ref: No. 135/CEUP/2023
6. Slovenia (Responsible partner: Jožef Stefan Institute) - The Republic of Slovenia National Medical Ethics Committee (Štefanova ulica 5, 1000 Ljubljana, Slovenia; +38 (0)1 478 69 06; kme.mz@gov.si), ref: 0120-398/2023/3
7. Sweden (Responsible partner: Karlstad University) - Swedish Ethical Review Authority, Etikprövningsmyndigheten (Box 2110, 750 02 Uppsala, Sweden; +46 (0)10 475 08 00; registrator@etikprovning.se), ref: 2024-01249-01-581358
8. UK (Responsible partner: University of Cambridge) - Yorkshire & The Humber - Bradford Leeds Research Ethics Committee (Jarrow Business Centre, Rolling Mill Road, Jarrow, E32 3DT, UK; +44 (0)207 104 8210; bradfordleeds.rec@hra.nhs.uk), ref: 322462
ConditionIndoor air quality
InterventionThe first part of the project (Phase 1) is a study involving a cross-sectional design across eight locations (200 homes and their inhabitants) without intervention. A subsequent smaller study (Phase 2, 100 homes and their inhabitants) aiming at testing strategies to improve IAQ has a case-crossover design, with a moderate sample size, resulting in outcome-based evidence of moderate confidence. The intervention strategies in this second phase aiming at improving IAQ will be selected based on the outcome of the first screenings in Phase 1. Strategies will likely be different across dwellings and will be chosen case by case to maximise the improvement of IAQ.

Technological (air purifier) and behavioural interventions will be selected for Phase 2 households, and non-randomly assigned based on Phase 1 outcomes.

The interventions and timings are:
1. Air purifier and smart ventilation systems (measured at >1 month after installation)
2. Ventilation behavior (measured at >1 month after implementation)
3. Cleaning behavior (measured at >1 month after implementation)
4. Green buildings (existing buildings, no specific timing)
5. Renovation and refurnishing (measured at >1 month after installation)
6. Consumer product introduction/removal (measured at >1 month after implementation)
Intervention typeMixed
Primary outcome measure1. Indoor air quality measured using low-cost air quality sensors over a 28-day period at baseline conditions (time=0) and 1-month post-intervention
2. Indoor levels of semi-volatile organic compounds measured using passive PDMS sorbent over a 28-day period at baseline conditions (time=0) and 1-month post-intervention
3. Outdoor, home-adjacent levels of semi-volatile organic compounds measured using passive PDMS sorbent over a 28-day period at baseline conditions (time=0) and 1-month post-intervention
4. Levels of semi- and non-volatile organic compounds measured in settled house dust by chemical extraction and instrumental analysis (composite, Day 1 and Day 28 of baseline period, and 1-month post-intervention)
5. Biological profiling of settled house dust, by gel clot LAL test and Amplicon sequencing (composite, Day 1 and Day 28, and 1-month post-intervention)
6. Indoor profiles of volatile organic compounds measured using passive sorbent over a 7-day period at baseline conditions (time=0) and 1-month post-intervention
7. Outdoor, home-adjacent profiles of volatile organic compounds measured using passive sorbent over a 7-day period at baseline conditions (time=0) and 1-month post-intervention
8. Biomarkers of chemical exposure in human urine, measured by liquid chromatography with tandem mass spectrometry (LC-MS/MS) at Day 28 and 1-month post-intervention
Secondary outcome measures1. Toxicological profiling of settled house dust (composite, Day 1 and Day 28), measured by bioassays for oxidative stress, cytotoxicity, endocrine disruption and immunotoxicity
2. Toxicological profiling of indoor aerosols measured using active sampler collection over a 28-day period at baseline conditions (time=0), measured by lung barrier integrity, inflammatory and oxidative stress response
3. Levels of chemical additives in household products measured using direct sampling or wiping and fast screening ambient mass spectrometry on Day 28
4. Self-perceived indoor air quality measured by questionnaire on Day 28
Overall study start date01/09/2022
Overall study end date31/08/2027

Eligibility

Participant type(s)All
Age groupMixed
SexBoth
Target number of participants200 households, 400 participants (1 adult, 1 child per household)
Participant inclusion criteriaRecruitment is at a household level. Households must have:
1. At least one child under 5 years of age at the time of recruitment
2. Reside in one of the designated areas specified by each local sampling partner
Participant exclusion criteria1. Household does not have a child under 5 years of age
2. Child spends more than 10 nights per month away from home
3. Any resident smokes inside the home
Recruitment start date01/05/2023
Recruitment end date31/05/2024

Locations

Countries of recruitment

  • Czech Republic
  • England
  • Estonia
  • Italy
  • Netherlands
  • Portugal
  • Slovenia
  • Sweden
  • United Kingdom

Study participating centres

Masarykova Univerzita
Zerotinovo namesti 9
Brno
601 77
Czech Republic
Terviseamet
Paldski Mnt 81
Tallinn
10617
Estonia
Institut Jozef Stefan
Jamova 39
Ljubljana
1000
Slovenia
Karlstads Universitet
Universitetsgatan 2
Karlstad
651 88
Sweden
Stichting VU
De Boelelaan 1105
Amsterdam
1081 HV
Netherlands
Istituto Superiore Di Sanita
Viale Regina Elena 299
Roma
00161
Italy
INEGI - Instituto De Ciencia E Inovacao Em Engenharia Mecanica E Engenharia Industrial
Rua Dr Roberto Frias 400
Porto
4200 465
Portugal
University of Cambridge
The Old Schools
Trinity Lane
Cambridge
CB2 1TN
United Kingdom

Sponsor information

Norwegian Institute for Air Research
Research organisation

Instituttveien 18
Kjeller
2027
Norway

Phone +47 (0)63 89 81 74
Email inquire@nilu.no
Website https://www.nilu.com/
ROR logo "ROR" https://ror.org/00q7d9z06

Funders

Funder type

Government

HORIZON EUROPE Framework Programme
Government organisation / National government
Alternative name(s)
Horizon Europe, Horizon Europe Programme, Framework Programme, Horizon Europe, EU Framework Programme, Horizon
UK Research and Innovation
Government organisation / National government
Alternative name(s)
UKRI
Location
United Kingdom

Results and Publications

Intention to publish date31/08/2028
Individual participant data (IPD) Intention to shareYes
IPD sharing plan summaryStored in publicly available repository, Available on request
Publication and dissemination planPlanned publications in open access high-impact peer-reviewed journals.
IPD sharing planData from INQUIRE (raw and pre-processed data, data analysis and modelling results) will be transferred to external trusted FAIR repositories. No single repository will be able to offer detailed metadata formats and fine-grained search and query options for all types of generated data. Therefore, sub-datasets will be deposited in discipline-specific repositories. The INQUIRE MasterDataset, which will allow linking all distributed sub-datasets through linked persistent identifiers (PIDs), will be deposited at Zenodo, B2SHARE or similar. Part of the INQUIRE data (i.e., quantitative chemical data, biological data and possibly biomonitoring data) will be made available through IPCHEM. Other public repositories will be identified during the course of the study. Informed consent will be obtained from all participants explicitly covering data sharing in GDPR-compliant repositories.

Editorial Notes

31/05/2024: The recruitment end date was changed from 31/12/2023 to 31/05/2024.
02/06/2023: The following changes were made to the trial record:
1. The recruitment end date was changed from 03/04/2023 to 01/05/2023.
2. The ethics approval was added.
13/03/2023: Trial's existence confirmed by the European Health and Digital Executive Agency (HADEA).