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Studying the effect of air pollutants on health

Hazard identification platform to assess the health impacts of indoor and outdoor air pollution exposures, through mechanistic toxicology (HIPTOX)

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ISRCTN
Registry ID
ISRCTN85634746
Enrollment
45
Registered
2023-03-20
Start date
2022-12-13
Completion date
Unknown
Last updated
2025-01-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

This is a study of healthy volunteers aged 50 years or above who have a close relative with dementia Not Applicable

Interventions

Healthy volunteers will be recruited and will undergo cognitive testing, spirometry, blood tests for biomarkers, and nasal lavage and will then undergo controlled pollutant exposures: 1. Diesel 2. Cle

Sponsors

University of Manchester
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Aged =50 years old 2. Family history of dementia 3. Provision of signed, written and dated informed consent, prior to any study-specific procedures

Exclusion criteria

Exclusion criteria: 1. Neurological or psychiatric disorder 2. General Practitioner Assessment of Cognition Score of =7 3. Current smoker (including e-cigarettes) or ex-smoker of less than 6 months abstinence, and >20 pack-year history 4. Current pregnancy 5. Significantly abnormal spirometry 6. History of cardiac disease 7. History of chronic respiratory or airways disease 8. History of inflammatory diseases (e.g. rheumatoid arthritis, chronic periodontitis, inflammatory bowel disease) 9. History of neurological or psychiatric disorders 10. History of organ transplant 11. Consumption of >3 units of alcohol in the 24 hours preceding the testing visit 12. Any vaccination in the week prior to the testing visit 13. Cold or flu in the 48 hours prior to the testing visit 14. Visual impairment not correctable with glasses/contact lenses. 15. Significant claustrophobia preventing the participant from wearing a mask over the nose and mouth for an hour 16. Concomitant medication use of neurologically active drugs such as opiates/benzodiazepines/anti-epileptics etc 17. Substance misuse

Design outcomes

Primary

MeasureTime frame
Evidence of impairment in cognitive function post-exposure measured using any of these cognitive tasks compared to clean air on each visit both at baseline (pre-pollutant exposure) and 3.5 hours post-exposure: 1. Socio-emotional cognitive functioning measured by ‘Approach bias’, calculated as ?d' (change in “dee-prime”), a sensitivity towards positive-affective (smiling face) stimuli comparative to negative-affective (fearful face) stimuli, using the Expression Recognition Task 2. Executive cognitive functioning measured by ‘Cognitive Control’, calculated as ?RT (change in response time), a difference between response time on trials of high conflict (more distracting two-face trials following less distracting one-face trials) compared to low conflict (two-face trials following two-face trials), using the Face Identification Task 3. Working memory ability is measured by ‘discrimination’, calculated as d' (“dee-prime”), a measure of discrimination for if the location of a square is in the same (or a different) position as a square shown 2 squares previously

Secondary

MeasureTime frame
1. Change in any of these cognitive tasks post pollutant exposures compared to clean air on each visit both at baseline (pre-pollutant exposure) and 3.5 hours post-exposure: 1.2 Sustained Attention measured by ‘Long Response Time (RT)’, the speed at which stimuli are responded to after a long wait (25-35 seconds). Psychomotor Speed is measured by ‘Short Response Time (RT)’, the speed at which stimuli presented rapidly (less than two seconds of each other) are responded to. Both these metrics are measured using the Psychomotor Vigilance Task. 1.2. Coarse motor movement is measured by ‘Right + Left + Both’ score, the number of metal pegs participants can move into a plastic board in 30 seconds with their right hand, left hands, and both hands together. Fine motor movement is measured by the ‘Assembly’ score, the number of metal parts participants can build into a plastic board in 60 seconds alternating their dominant and non-dominant hand. These are measured using the Pegboard Test. 2. Change in lung function post-exposure to pollutants compared to clean air measured using spirometry, FEV1 in litres and FVC in litres, pre and post exposures 3. Change in the DNA post pollutant exposure compared to clean air measured using blood tests for biomarkers and fluid samples collected from the nasal wash/lavage pre and post exposures

Countries

England, United Kingdom

Contacts

Public ContactHuda Badri
huda.badri@postgrad.manchester.ac.uk+44 (0)7968629781

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026