NCT05507944

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Sep 2022

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 17, 2022

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 19, 2022

Completed
27 days until next milestone

Study Start

First participant enrolled

September 15, 2022

Completed
15 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2022

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 15, 2022

Completed
Last Updated

December 6, 2022

Status Verified

August 1, 2022

Enrollment Period

15 days

First QC Date

August 17, 2022

Last Update Submit

December 2, 2022

Conditions

Keywords

Airway irritants

Outcome Measures

Primary Outcomes (4)

  • Daily FeNO (ppb measured by Niox Vero) increase after occupational exposure.

    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.

    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.

    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.

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

    6 days

Study Arms (2)

Healthcare workers at Oslo University Hospital

Occupational control. Environmental exposure during commuting.

Diagnostic Test: FeNO measurement

Hairdressers

Occupational exposure for airway irritants during hairdressing. Environmental exposure during commuting.

Diagnostic Test: FeNO measurement

Interventions

FeNO measurementDIAGNOSTIC_TEST

Diurnal measurements before work and at 3 hours after work start.

HairdressersHealthcare workers at Oslo University Hospital

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

  • 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.

You may not qualify if:

  • lung disease.
  • active smoker.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Oslo University Hospital

Oslo, 0139, Norway

Location

Study Officials

  • Bato Hammarstrøm, MD/PhD

    Oslo University Hospital

    PRINCIPAL INVESTIGATOR
  • 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 CHAIR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
6 Days
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Senior consultant

Study Record Dates

First Submitted

August 17, 2022

First Posted

August 19, 2022

Study Start

September 15, 2022

Primary Completion

September 30, 2022

Study Completion

November 15, 2022

Last Updated

December 6, 2022

Record last verified: 2022-08

Data Sharing

IPD Sharing
Will not share

Locations