NCT04915560

Brief Summary

The purpose of the study is to test the feasibility of the monitoring of physiological parameters during operations of industrial cleaning

Trial Health

30
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Timeline
Completed

Started Jun 2021

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
withdrawn

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

May 25, 2021

Completed
13 days until next milestone

First Posted

Study publicly available on registry

June 7, 2021

Completed
2 days until next milestone

Study Start

First participant enrolled

June 9, 2021

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 15, 2023

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

November 15, 2023

Completed
Last Updated

May 25, 2023

Status Verified

May 1, 2023

Enrollment Period

2.4 years

First QC Date

May 25, 2021

Last Update Submit

May 23, 2023

Conditions

Work-Related Condition

Outcome Measures

Primary Outcomes (1)

  • 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.

    12 months

Secondary Outcomes (1)

  • Percentage of alarms processed in less than 3 minutes

    12 months

Study Arms (1)

ORTEC Employee

EXPERIMENTAL

ORTEC professional employees performing an industrial cleaning task.

Device: Connected T-shirt

Interventions

Connected T-shirtDEVICE

Ware of a connected T-shirt

ORTEC Employee

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Employee involved in industrial cleaning task of non-ATEX sites (EXplosive ATmosphere)
  • Affiliation to the French National healthcare system
  • French speaking employee

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU

Angers, France

Location

Study Officials

  • Samir HENNI, MD, PhD

    University Hospital, Angers

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DEVICE FEASIBILITY
Intervention Model
SINGLE GROUP
Model Details: Percentage of valid data obtains from a professional performing an industrial cleaning task wearing a connected T-shirt.
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 25, 2021

First Posted

June 7, 2021

Study Start

June 9, 2021

Primary Completion

October 15, 2023

Study Completion

November 15, 2023

Last Updated

May 25, 2023

Record last verified: 2023-05

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)