Occupational ExposureNCT05507944
FeNO Hairdressers Pilot
An observational study of Occupational Exposure and Environmental Exposure, run by Oslo University Hospital at 1 site in Norway.
Trial summary
A 5-day cohort diurnal FeNO study of exposed and unexposed to airway irritants during hair treatments and commuting. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Occupational Exposure, Environmental Exposure
- What is being tested?
- FeNO measurement
- How many people
- 30 participants
- Where
- 1 siteNorway
- Study dates
- 15 Sep 2022to 15 Nov 2022
- How long will I take part?
- 6 Days
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
Study population: Employed as hairdressers or at Oslo University Hospital as healthcare workers.
Who may be able to join
- 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.
Who cannot join
- lung disease.
- active smoker.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Occupational Exposure, Environmental Exposure
- Being tested
- FeNO measurement
- Keywords
- Airway irritants
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FeNO measurementDiagnostic test
Diurnal measurements before work and at 3 hours after work start.
| Study group | Role | What they receive |
|---|---|---|
| Healthcare workers at Oslo University Hospital | Occupational control.
Environmental exposure during commuting. Receives: Diagnostic Test: FeNO measurement | |
| Hairdressers | Occupational exposure for airway irritants during hairdressing.
Environmental exposure during commuting. Receives: Diagnostic Test: FeNO measurement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Daily FeNO (ppb measured by Niox Vero) increase after occupational exposure.
At start of work and after 3 hours. Hardressers vs. Health care workers.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 6 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2022
- Study start15 Sep 2022
- Primary completion30 Sep 2022
- Study completion15 Nov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Occupational ExposureStudies of the same condition, open and under way.
- More trials run by Oslo University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 30 participants (actual)
- Target duration
- 6 Days
Sponsor and investigators
- Lead sponsor
- Oslo University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bato Hammarstrøm, Oslo University Hospital
- Investigators
- Bato Hammarstrøm, MD/PhD, Principal investigator, Oslo University HospitalHilde Heiro, MD, Study chair, Oslo University HospitalTonje Trulssen Hildre, MSc., Study chair, Oslo University HospitalIngill Sandven, MD, Study chair, Oslo University HospitalBritt G Randem, MD/PhD, Study chair, Oslo University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05507944
- Sponsor's protocol ID
- 22/16786
- Status last verified
- Aug 2022
- First submitted
- 17 Aug 2022
- Last updated
- 6 Dec 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fraction of Exhaled Nitric Oxide (FeNO) in an Occupational Cohort of Hairdressers
- ClinicalTrials.gov ID
- NCT05507944
- Acronym / sponsor ID
- 22/16786
- Conditions
- Occupational Exposure, Environmental Exposure
- Keywords
- Airway irritants
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Oslo University HospitalUniversity, hospital or other
- Study start
- 15 Sep 2022 (actual)
- Primary completion
- 30 Sep 2022 (actual)
- Study completion
- 15 Nov 2022 (actual)
- First posted
- 19 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A 5-day cohort diurnal FeNO study of exposed and unexposed to airway irritants during hair treatments and commuting.
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
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 6 Days
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Healthcare workers at Oslo University Hospital | – | Diagnostic Test: FeNO measurementOccupational control. Environmental exposure during commuting. |
| Hairdressers | – | Diagnostic Test: FeNO measurementOccupational exposure for airway irritants during hairdressing. Environmental exposure during commuting. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Employed as hairdressers or at Oslo University Hospital as healthcare workers.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (2 listed)
- lung disease.
- active smoker.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FeNO measurementDiurnal measurements before work and at 3 hours after work start. | Diagnostic test | Hairdressers, Healthcare workers at Oslo University Hospital |
Primary outcome
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.
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.
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Dec 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bato Hammarstrøm, MD/PhD principal investigator
Oslo University Hospital
Hilde Heiro, MD study chair
Oslo University Hospital
Tonje Trulssen Hildre, MSc. study chair
Oslo University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Occupational Exposure and Environmental Exposure, run by Oslo University Hospital at 1 site in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Daily FeNO (ppb measured by Niox Vero) increase after occupational exposure. (time frame: 1 day.). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Dec 2022.