FeNO Hairdressers Pilot

December 2, 2022 updated by: Bato Hammarstrøm, Oslo University Hospital

Fraction of Exhaled Nitric Oxide (FeNO) in an Occupational Cohort of Hairdressers

A 5-day cohort diurnal FeNO study of exposed and unexposed to airway irritants during hair treatments and commuting.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The project aims to increase the knowledge of daily variations in FeNO with emphasis on exposure of airway irritants during hairdressing treatments in an occupational setting and commuting. Daily measurements of FeNO before and after workplace exposure in an exposed and an unexposed cohort during a workweek (Monday to Saturday) will indicate patterns of proinflammatory responses in a dose-dependent manner. These may or may not be indicative of an increased risk for airway related disease. Results may be used for further studies of occupational hygiene, airway related disease and identification of endogenous volatile organic compounds during proinflammatory responses.

Study Type

Observational

Enrollment (Actual)

30

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Norway
      • Oslo, Norway, 0139
        • Oslo University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Employed as hairdressers or at Oslo University Hospital as healthcare workers.

Description

Inclusion Criteria:

  • have given informed consent.
  • employed as hairdressers or at Oslo University Hospital as healthcare workers.
  • scheduled work for at least 3 hours daily for 5 days in the study week.

Exclusion Criteria:

  • lung disease.
  • active smoker.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Healthcare workers at Oslo University Hospital

Occupational control.

Environmental exposure during commuting.
Diagnostic test: FeNO measurement
Diurnal measurements before work and at 3 hours after work start.
Hairdressers

Occupational exposure for airway irritants during hairdressing.

Environmental exposure during commuting.
Diagnostic test: FeNO measurement
Diurnal measurements before work and at 3 hours after work start.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Daily FeNO (ppb measured by Niox Vero) increase after occupational exposure.
Time Frame: 1 day.
At start of work and after 3 hours. Hardressers vs. Health care workers.
1 day.
Daily FeNO (ppb measured by Niox Vero) increase after enviromental exposure during commuting.
Time Frame: 1 day.
At start of work and after 3 hours. Subgrouped after way of commuting.
1 day.
Diurnal FeNO (ppb measured by Niox Vero) variations during a work week after occupational exposure.
Time Frame: 6 days
At start of work and after 3 hours. Hardressers vs. Health care workers.
6 days
Diurnal FeNO (ppb measured by Niox Vero) variations during a work week after environmental exposure during commuting.
Time Frame: 6 days
At start of work and after 3 hours. Subgrouped after way of commuting.
6 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Oslo University Hospital

Investigators

  • Principal Investigator: Bato Hammarstrøm, MD/PhD, Oslo University Hospital
  • Study Chair: Hilde Heiro, MD, Oslo University Hospital
  • Study Chair: Tonje Trulssen Hildre, MSc., Oslo University Hospital
  • Study Chair: Ingill Sandven, MD, Oslo University Hospital
  • Study Chair: Britt G Randem, MD/PhD, Oslo University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 15, 2022

Primary Completion (Actual)

September 30, 2022

Study Completion (Actual)

November 15, 2022

Study Registration Dates

First Submitted

August 17, 2022

First Submitted That Met QC Criteria

August 18, 2022

First Posted (Actual)

August 19, 2022

Study Record Updates

Last Update Posted (Estimate)

December 6, 2022

Last Update Submitted That Met QC Criteria

December 2, 2022

Last Verified

August 1, 2022

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 22/16786

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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