## Protocol Section
### Identification Module
**NCT ID:** NCT02892279

**Brief Title:** Sympathetic Nerve Activation Evoked by Diesel Exhaust Exposure

**Official Title:** Sympathetic Nerve Activation Evoked by Diesel Exhaust Exposure

#### Organization Study ID Info
**ID:** Umu-2016-57-31
#### Organization
**Class:** OTHER
**Full Name:** Umeå University
### Status Module
#### Completion Date
**Date:** 2016-12

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2018-02-06

**Type:** ACTUAL

**Last Update Submit Date:** 2018-02-05

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2016-12

**Type:** ACTUAL

#### Start Date
**Date:** 2016-09

**Status Verified Date:** 2018-02

#### Study First Post Date
**Date:** 2016-09-08
**Type:** ESTIMATED
**Study First Submit Date:** 2016-09-02
**Study First Submit QC Date:** 2016-09-07
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Umeå University

#### Responsible Party

**Investigator Affiliation:** Umeå University

**Investigator Full Name:** Jenny Bosson

**Investigator Title:** MD, PhD

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Oversight Has DMC:** False

### Description Module

**Brief Summary:** The adverse effects of air pollution on cardiovascular and respiratory health have been demonstrated in an extensive series of epidemiological, observational and experimental studies. In the current project the investigators aim to determine whether an acute exposure to diesel exhaust causes impacts on sympathetic nervous system activation in healthy volunteers.

**Detailed Description:** Brief as well as chronic exposures to air pollution have been linked with increases in cardiovascular morbidity and mortality. Evidence suggests that the strongest associations between air pollution exposure and adverse cardiovascular effects are found for combustion-derived particulate matter, especially in the fine and ultrafine ranges such as is found in diesel engine emissions. Despite a greater understanding of the cardiovascular effects of air pollution, the underlying mechanism through which exposure to fine particulate air pollution alters vascular function has yet to be determined. Microneurography is a method that records nerve impulse traffic in human peripheral nerves, allowing for the assessment of sympathetic nervous activity. The current study will employed microneurography techniques to evaluate autonomic function in association with inhaled air pollution exposure in healthy human volunteers.

### Conditions Module

**Conditions:**

- Healthy

**Keywords:**

- Microneurography

- Air pollution

### Design Module

#### Design Info

**Allocation:** NA

**Intervention Model:** SINGLE_GROUP

##### Masking Info

**Masking:** NONE

**Primary Purpose:** BASIC_SCIENCE

#### Enrollment Info

**Count:** 15

**Type:** ACTUAL

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** A single arm study in which first a baseline muscle sympathetic nerve activity (MSNA) is recorded with and without an exposure mask. When measurements have been secured exposure to dilute diesel exhaust will start.

**Intervention Names:**

- Other: Diesel exhaust exposure

**Label:** Diesel exhaust exposure

**Type:** EXPERIMENTAL

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Diesel exhaust exposure

**Description:** Evaluation of sympathetic nervous system activity as assessed by microneurography recording during an acute exposure to dilute diesel exhaust via mask.

**Name:** Diesel exhaust exposure

**Type:** OTHER

### Outcomes Module

#### Primary Outcomes

**Description:** Microneurography recording of muscle sympathetic nervous system activity

**Measure:** Microneurography

**Time Frame:** 1 hour

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* Healthy (normal ECG, lung function, blood sample, clinical examination)

Exclusion Criteria:

* Metabolic disease
* Cardiovascular disease
* Respiratory disease
* BMI ≥ 30
* Use of psychoactive medication
* Infection within 2 weeks of the study
* Smokers or regular snus usage

**Healthy Volunteers:** True

**Maximum Age:** 45 Years

**Minimum Age:** 18 Years

**Sex:** MALE

**Standard Ages:**

- ADULT

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Umeå

**Country:** Sweden

**Facility:** Dept of Medicine, Lung and Allergy section, University Hospital

#### Overall Officials

**Official 1:**

**Affiliation:** Umeå University

**Name:** Jenny Bosson, MD, PhD

**Role:** PRINCIPAL_INVESTIGATOR

### IPD Sharing Statement Module

**IPD Sharing:** UNDECIDED

### References Module

#### References

**Citation:** Rankin GD, Kabele M, Brown R, Macefield VG, Sandstrom T, Bosson JA. Acute Exposure to Diesel Exhaust Increases Muscle Sympathetic Nerve Activity in Humans. J Am Heart Assoc. 2021 May 18;10(10):e018448. doi: 10.1161/JAHA.120.018448. Epub 2021 May 4.

**PMID:** 33942621

## Derived Section

### Misc Info Module

- Version Holder: 2024-05-24
