Effects on the Olfactory Epithelium and the Olfactory Nerve From Exposure to Diesel Exhaust (DINOSE)

Umeå University

Status: Completed

Conditions: Air Pollution Exposure; Dementia Alzheimer Type; Alzheimer Disease (AD)

Treatments: Other: Diesel Exhaust Particles; Other: Filtered air

Study type: Interventional

Funder types: Other

Identifiers

NCT07237958

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2018-438-31

Details and patient eligibility

About

The goal of this study is to study the effect exposure to air pollution and its effect on development of dementia.

Does the diesel exhaust change the function of the olfactory system?

Have the exposures measurable effects on the sense of smell and cognitive ability?

Forty people are exposed to diesel exhaust exhaust and filtered air. The exposures are blinded and in a randomized order. Both groups undergo biopsies of the olfactory epithelium in the nose under local anesthesia after the exposures and after performing cognitive test.

Enrollment: 40 patients

Sex: All

Ages: 20 to 70 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Healthy
• non-smoker

Exclusion criteria

• Allergic rhinitis
• Asthma
• Diabetes mellitus
• Kidney or liver failure
• Angina pectoris or previous ventricular arrhythmia
• Systolic blood pressure >190 mmHg or <100 mmHg
• Previous blood disease
• Blood donation in the last three months prior to study start
• Previous or ongoing tobacco smoking and exposure to air pollution in the workplace
• Absence of informed consent

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

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40 participants in 2 patient groups, including a placebo group

Exposure to diesel exhaust

Active Comparator group

Description:

The participants will be exposed in an exposure chamber for diesel exhaust in a concentration of 300 µg/m³ for one hour.

Treatment:

Other: Diesel Exhaust Particles

Exposure to filtered air

Placebo Comparator group

Description:

The participants will be exposed in an exposure chamber to filtered air for one hour.

Treatment:

Other: Filtered air