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FeNO Hairdressers Pilot

Sponsor
Oslo University Hospital (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05507944
Collaborator
(none)
30
Enrollment
1
Location
3.5
Anticipated Duration (Months)
8.5
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: FeNO measurement

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 Design

Study Type:
Observational [Patient Registry]
Anticipated Enrollment :
30 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Fraction of Exhaled Nitric Oxide (FeNO) in an Occupational Cohort of Hairdressers
Anticipated Study Start Date :
Sep 15, 2022
Anticipated Primary Completion Date :
Sep 30, 2022
Anticipated Study Completion Date :
Dec 31, 2022

Arms and Interventions

Arm 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.

Outcome Measures

Primary Outcome Measures

  1. Daily FeNO (ppb measured by Niox Vero) increase after occupational exposure. [1 day.]

    At start of work and after 3 hours. Hardressers vs. Health care workers.

  2. Daily FeNO (ppb measured by Niox Vero) increase after enviromental exposure during commuting. [1 day.]

    At start of work and after 3 hours. Subgrouped after way of commuting.

  3. Diurnal FeNO (ppb measured by Niox Vero) variations during a work week after occupational exposure. [6 days]

    At start of work and after 3 hours. Hardressers vs. Health care workers.

  4. Diurnal FeNO (ppb measured by Niox Vero) variations during a work week after environmental exposure during commuting. [6 days]

    At start of work and after 3 hours. Subgrouped after way of commuting.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Oslo University Hospital Oslo Norway 0139

Sponsors and Collaborators

  • 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 Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Bato Hammarstrøm, Senior consultant, Oslo University Hospital
ClinicalTrials.gov Identifier:
NCT05507944
Other Study ID Numbers:
  • 22/16786
First Posted:
Aug 19, 2022
Last Update Posted:
Aug 24, 2022
Last Verified:
Aug 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Bato Hammarstrøm, Senior consultant, Oslo University Hospital
Airway irritants

Study Results

No Results Posted as of Aug 24, 2022