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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-02-01

Study Completion Date

2023-05-19

Brief Summary

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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.

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Detailed Description

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Conditions

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Alzheimer Disease (AD) Dementia Alzheimer Type Air Pollution Exposure

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Exposure to diesel exhaust

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

Group Type ACTIVE_COMPARATOR

Diesel Exhaust Particles

Intervention Type OTHER

During exposure to diesel exhaust, participants alternate between 15-minute periods of rest and exercise on an ergometer cycle with a workload that results in a minute ventilation of 20L/min/m² body surface area. Symptom recording is done every 30 minutes, following a routine based on a modified Borg scale.

Exposure to filtered air

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

Group Type PLACEBO_COMPARATOR

Filtered air

Intervention Type OTHER

During exposure to filtered air, participants alternate between 15-minute periods of rest and exercise on an ergometer cycle with a workload that results in a minute ventilation of 20L/min/m² body surface area. Symptom recording is done every 30 minutes, following a routine based on a modified Borg scale

Interventions

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Diesel Exhaust Particles

During exposure to diesel exhaust, participants alternate between 15-minute periods of rest and exercise on an ergometer cycle with a workload that results in a minute ventilation of 20L/min/m² body surface area. Symptom recording is done every 30 minutes, following a routine based on a modified Borg scale.

Intervention Type OTHER

Filtered air

During exposure to filtered air, participants alternate between 15-minute periods of rest and exercise on an ergometer cycle with a workload that results in a minute ventilation of 20L/min/m² body surface area. Symptom recording is done every 30 minutes, following a routine based on a modified Borg scale

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

20 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes