Work-Related ConditionTIGERNCT04915560
Feasibility of a Physiological Monitoring for Teleassistance to Isolated Workers in Industrial Cleaning
A study testing Connected T-shirt in people with Work-Related Condition, run by University Hospital, Angers at 1 site in France.
Trial summary
The purpose of the study is to test the feasibility of the monitoring of physiological parameters during operations of industrial cleaning Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Work-Related Condition
- What is being tested?
- Connected T-shirt
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteFrance
- Study dates
- 9 Jun 2021to 15 Nov 2023
- Phase
- Interventional
- 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
Who may be able to join
- Employee involved in industrial cleaning task of non-ATEX sites (EXplosive ATmosphere)
- Affiliation to the French National healthcare system
- French speaking employee
Who cannot join
- Contraindication to the measures or procedures provided for in the study (physical characteristics do not allow measurements to be taken, wounds, etc.)
- Pregnancy
- Inability to understand the study goal
- Employee protected by decision of law
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Etude de faisabilité Portant Sur un Dispositif de Monitoring Physiologique et d'Une Chaine de téléassistance Des Travailleurs isolés au Sein d'Une société de Nettoyage Industriel.
The purpose of the study is to test the feasibility of the monitoring of physiological parameters during operations of industrial cleaning
Read the detailed description
A letter about TIGER study is sent to employees eligible to participate. For volunteers, a written consent is signed after complete oral and written explanation of the protocol is signed.
On the day of the industrial cleaning task, the employee wears the connected t-shirt and performs the cleaning. Data are retrieved on a 5 min interval basis. Physiological parameters above or beyond pre-defined limits are transmitted as potential alarms to an operational teleassistance center. A missing data (Invalid recording) are considered alarms.
The number and causes of alarms are determined after the end of the cleaning task.
- Conditions
- Work-Related Condition
- Being tested
- Connected T-shirt
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Connected T-shirtDevice
Ware of a connected T-shirt
| Study group | Role | What they receive |
|---|---|---|
| ORTEC Employee | Experimental | ORTEC professional employees performing an industrial cleaning task. Receives: Device: Connected T-shirt |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of T-shirt recording
Percentage of valid data from connected T-Shirt. The physiological data is fed back to an integrator and values for respiratory rate (FR), heart rate (HR), temperature (T °) and activity index are calculated over a period of 5 minutes. These values are only calculated if 15% of the raw data can be used over each period of 5 minutes.
Measured: 12 months
Secondary outcomes (1)
Percentage of alarms processed in less than 3 minutes
Number of alarms processed in less than 3 minutes
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2021
- Study start9 Jun 2021
- Primary completion15 Oct 2023 (estimated)
- Study completion15 Nov 2023 (estimated)
Why it stopped: The French committee refused the amendment.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Work-Related ConditionStudies of the same condition, open and under way.
- More trials run by University Hospital, AngersThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Percentage of valid data obtains from a professional performing an industrial cleaning task wearing a connected T-shirt.
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Angers
- Sponsor type
- Other government
- Collaborators
- Ortec International
- Responsible party
- Sponsor
- Investigators
- Samir HENNI, MD, PhD, Principal investigator, University Hospital, Angers
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04915560
- Sponsor's protocol ID
- 2021-A01390-41
- Acronym
- TIGER
- Status last verified
- May 2023
- First submitted
- 25 May 2021
- Last updated
- 25 May 2023
- Results posted
- No
- Data monitoring committee
- Yes
- 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 25 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Etude de faisabilité Portant Sur un Dispositif de Monitoring Physiologique et d'Une Chaine de téléassistance Des Travailleurs isolés au Sein d'Une société de Nettoyage Industriel.
- ClinicalTrials.gov ID
- NCT04915560
- Acronym / sponsor ID
- TIGER / 2021-A01390-41
- Conditions
- Work-Related Condition
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: The French committee refused the amendment.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University Hospital, AngersOther government
- Collaborators
- Ortec International
- Study start
- 9 Jun 2021 (actual)
- Primary completion
- 15 Oct 2023 (estimated)
- Study completion
- 15 Nov 2023 (estimated)
- First posted
- 7 Jun 2021 (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 purpose of the study is to test the feasibility of the monitoring of physiological parameters during operations of industrial cleaning
Detailed description
A letter about TIGER study is sent to employees eligible to participate. For volunteers, a written consent is signed after complete oral and written explanation of the protocol is signed.
On the day of the industrial cleaning task, the employee wears the connected t-shirt and performs the cleaning. Data are retrieved on a 5 min interval basis. Physiological parameters above or beyond pre-defined limits are transmitted as potential alarms to an operational teleassistance center. A missing data (Invalid recording) are considered alarms.
The number and causes of alarms are determined after the end of the cleaning task.
Study design
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Percentage of valid data obtains from a professional performing an industrial cleaning task wearing a connected T-shirt.
| Arm | Type | Receives |
|---|---|---|
| ORTEC Employee | Experimental | Device: Connected T-shirtORTEC professional employees performing an industrial cleaning task. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Employee involved in industrial cleaning task of non-ATEX sites (EXplosive ATmosphere)
- Affiliation to the French National healthcare system
- French speaking employee
Key exclusion criteria (4 listed)
- Contraindication to the measures or procedures provided for in the study (physical characteristics do not allow measurements to be taken, wounds, etc.)
- Pregnancy
- Inability to understand the study goal
- Employee protected by decision of law
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 |
|---|---|---|
| Connected T-shirtWare of a connected T-shirt | Device | ORTEC Employee |
Primary outcome
Feasibility of T-shirt recording
Time frame: 12 months
Percentage of valid data from connected T-Shirt. The physiological data is fed back to an integrator and values for respiratory rate (FR), heart rate (HR), temperature (T °) and activity index are calculated over a period of 5 minutes. These values are only calculated if 15% of the raw data can be used over each period of 5 minutes.
1 secondary outcome
Percentage of alarms processed in less than 3 minutes
Time frame: 12 months
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 25 May 2023.
- 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.
Samir HENNI, MD, PhD principal investigator
University Hospital, Angers
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Connected T-shirt in people with Work-Related Condition, run by University Hospital, Angers at 1 site in France.
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 4 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 25 May 2023. 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 France. 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 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?
Feasibility of T-shirt recording (time frame: 12 months). 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 25 May 2023.