Ignite Creation Date:
2024-05-06 @ 7:40 PM
Last Modification Date:
2024-10-26 @ 3:11 PM
Study NCT ID:
NCT06099145
Status:
RECRUITING
Last Update Posted:
2023-10-25
First Post:
2023-10-19
Brief Title:
Clinical and Medico-economic Validation of the HEPHAI Solution
Sponsor:
Hephai
Organization:
Hephai
Study Overview
Official Title:
Clinical and Medico-economic Study to Validate the Performance of a Digital and Personalized Solution HEPHAÏ to Support the Use of Inhaled Treatments for Asthma and COPD
Status:
RECRUITING
Status Verified Date:
2023-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
VAL-HEPHAI
Brief Summary:
In a context where the use of inhalation devices for respiratory medications is associated with a high frequency of critical errors our primary hypothesis is that the use of the HEPHAÏ solution reduces this frequency compared to standard care
The objective of this clinical study is to evaluate the performance of the HEPHAÏ solution as a tool for improving the administration of inhaled treatments in patients undergoing pulmonary care for asthma andor COPD who are receiving treatment with Innovair or Trimbow These two inhalers were chosen for reasons of feasibility and compatibility with the version of the HEPHAÏ software provided as part of the clinical investigation
The objective of this clinical study is to evaluate the performance of the HEPHAÏ solution as a tool for improving the administration of inhaled treatments in patients undergoing pulmonary care for asthma andor COPD who are receiving treatment with Innovair or Trimbow These two inhalers were chosen for reasons of feasibility and compatibility with the version of the HEPHAÏ software provided as part of the clinical investigation
Detailed Description:
The proper use of inhalation devices is crucial to relieving asthma and COPD symptoms and preventing exacerbations of these diseases The improper use of these devices is currently considered a major problem HEPHAI Class I Medical Device is a versatile application based on artificial intelligence AI allowing to recognize the appropriate use of an inhalation device by analyzing without any sensors either on the patient or on the inhaler the sequence of movements and sounds necessary for error-free intake The HEPHAI application allows the patient to film themselves directly when using their inhaler to interrogate in real time an AI based on behavior recognition movements and sounds to give the patient an immediate result and to set up a corrective process if the intake has not been properly carried out
HEPHAÏ is thus a companion tool to the inhaler prescribed by the doctor which allows the patient to benefit from assistance in the use of his or her personalized inhaler at home
Among patients using an inhalation device for their treatment 30 to 40 make errors of use that are considered critical ie making the treatment ineffective or drastically reducing its effectiveness Beyond its clinical impact persistence of symptoms decreased adherence increased risk of exacerbation the economic cost of this inadequate use is estimated at nearly one billion euros per year in France with a major weight of hospitalizations for exacerbations
In this contaxt the objective of the present study is to evaluate the performance of the HEPHAÏ solution as a tool for improving the administration of inhaled treatments in patients undergoing pulmonary care for asthma andor COPD
HEPHAÏ is thus a companion tool to the inhaler prescribed by the doctor which allows the patient to benefit from assistance in the use of his or her personalized inhaler at home
Among patients using an inhalation device for their treatment 30 to 40 make errors of use that are considered critical ie making the treatment ineffective or drastically reducing its effectiveness Beyond its clinical impact persistence of symptoms decreased adherence increased risk of exacerbation the economic cost of this inadequate use is estimated at nearly one billion euros per year in France with a major weight of hospitalizations for exacerbations
In this contaxt the objective of the present study is to evaluate the performance of the HEPHAÏ solution as a tool for improving the administration of inhaled treatments in patients undergoing pulmonary care for asthma andor COPD
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None