Environmental ExposureNCT04343495
UV and Bluelight Dosimetry
An observational study of Environmental Exposure, run by Northwestern University.
Trial summary
The objective of this study to assess the efficacy of wearable Ultra Violet (UV) and blue-light sensors in measuring exposure to UV radiation and blue light in a variety of environments and activity settings. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Environmental Exposure
- What is being tested?
- Wearable Ultra Violet (UV) and blue-light sensors
- Type of treatment
- Medical device
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 1 Jul 2022to 1 Feb 2024
- 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: Adults
Who may be able to join
- Age ≥18 years old
- Subjects willing and able to comply with requirements of the protocol
- Subjects speaking English
Who cannot join
- Age <18 years old
- Subjects unwilling and unable to comply with requirements of the protocol
- History of skin allergy to medical adhesive tape or rubber bands/elastic
- Lack of proficiency in English
- Skin disorders affecting skin integrity
About this study
Official title: Pilot Studies of UV-A, UV-B, and Blue-light Dosimetry Sensors
The objective of this study to assess the efficacy of wearable Ultra Violet (UV) and blue-light sensors in measuring exposure to UV radiation and blue light in a variety of environments and activity settings.
- Conditions
- Environmental Exposure
- Being tested
- Wearable Ultra Violet (UV) and blue-light sensors
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Wearable Ultra Violet (UV) and blue-light sensorsDevice
Non-blinded
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of various types of light exposure at various, targeted regions of the body while engaging in a different activities and settings.
After sensors are removed researchers will collect dosimetry data using a phone application using Near Field Communication (NFC) with a phone that is restricted to research use only in this study. Location, indoor/outdoor conditions and time that the devices are used will be recorded by the study team.
Location, external environmental factors (weather, UV index) and activities will be recorded by the research administrators.
Measured: Time Frame: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2020
- Study start1 Jul 2022 (estimated)
- Primary completion1 Dec 2023 (estimated)
- Study completion1 Feb 2024 (estimated)
Why it stopped: PI left institution and study has not begun enrollment.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Environmental ExposureStudies of the same condition, open and under way.
- More trials run by Northwestern UniversityThe 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
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northwestern University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shuai (Steve) Xu, Northwestern University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04343495
- Sponsor's protocol ID
- STU00209872
- Status last verified
- Sep 2022
- First submitted
- 30 Mar 2020
- Last updated
- 29 Sep 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Studies of UV-A, UV-B, and Blue-light Dosimetry Sensors
- ClinicalTrials.gov ID
- NCT04343495
- Acronym / sponsor ID
- STU00209872
- Conditions
- Environmental Exposure
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: PI left institution and study has not begun enrollment.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Northwestern UniversityUniversity, hospital or other
- Study start
- 1 Jul 2022 (estimated)
- Primary completion
- 1 Dec 2023 (estimated)
- Study completion
- 1 Feb 2024 (estimated)
- First posted
- 13 Apr 2020 (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.
The objective of this study to assess the efficacy of wearable Ultra Violet (UV) and blue-light sensors in measuring exposure to UV radiation and blue light in a variety of environments and activity settings.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Adults
Key inclusion criteria (3 listed)
- Age ≥18 years old
- Subjects willing and able to comply with requirements of the protocol
- Subjects speaking English
Key exclusion criteria (5 listed)
- Age <18 years old
- Subjects unwilling and unable to comply with requirements of the protocol
- History of skin allergy to medical adhesive tape or rubber bands/elastic
- Lack of proficiency in English
- Skin disorders affecting skin integrity
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 |
|---|---|---|
| Wearable Ultra Violet (UV) and blue-light sensorsNon-blinded | Device | – |
Primary outcome
Evaluation of various types of light exposure at various, targeted regions of the body while engaging in a different activities and settings.
Time frame: Time Frame: 1 year
After sensors are removed researchers will collect dosimetry data using a phone application using Near Field Communication (NFC) with a phone that is restricted to research use only in this study. Location, indoor/outdoor conditions and time that the devices are used will be recorded by the study team. Location, external environmental factors (weather, UV index) and activities will be recorded by the research administrators.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2022.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Environmental Exposure, run by Northwestern University.
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 5 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: withdrawn, as of the sponsor's last update on 29 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
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 was withdrawn before enrolling participants, so there are no results.
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?
Evaluation of various types of light exposure at various, targeted regions of the body while engaging in a different activities and settings. (time frame: Time Frame: 1 year). 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 29 Sep 2022.