Clinical and Medico-economic Validation of the HEPHAI Solution. (VAL-HEPHAI)

H

Hephai

Status

Enrolling

Conditions

Asthma COPD

Treatments

Device: Hephaï

Study type

Interventional

Funder types

Industry

Identifiers

NCT06099145
KM00385

Details and patient eligibility

About

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 and/or 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

Full 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", i.e. 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 and/or COPD.

Enrollment

238 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Patient at least 18 years of age
  • Patient followed in pulmonology for Asthma and/or COPD with implementation and/or follow-up of treatment with Innovair® or Trimbow®,
  • Patient affiliated to a Social Security scheme,
  • Patient with a hardware support allowing the operation of HEPHAÏ: smartphone, tablet, desktop or laptop computer with graphical interface, video, sound and a high-speed connection at the place of use.

Exclusion criteria

  • Patient previously enrolled in another interventional clinical study,
  • Adult patients who are subject to a legal protection measure (guardianship, judicial safeguard, psychiatric care or deprived of liberty by judicial or administrative decision),
  • Patient with at least one sensory, visual or tactile impairment, preventing the correct use of a smartphone, tablet and/or computer or preventing the correct performance of the exercise safely,
  • Patient with a cognitive impairment, severely limiting their ability to concentrate and thus preventing the correct use of a smartphone, tablet and/or computer,
  • Patient cared for by a specialized team of education, therapeutic for his asthma or COPD follow-up (e.g. asthma school, asthma referent IDE),
  • Patient who does not understand French,
  • Patient with an inhalation chamber prescription associated with their inhalation device prescription.

Trial design

238 participants in 2 patient groups

Standard care
No Intervention group
Description:
Patient who received inhaled treatment with Innovair® or Trimbow® as a part standard care for 6 months
Hephai
Experimental group
Description:
Patient using the Hephaï medical device as a tool who received inhaled treatment with Innovair® or Trimbow® as a part standard care for 6 months
Treatment:
Device: Hephaï

Trial contacts and locations

0

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Central trial contact

Serge Kinkingnehun

Data sourced from clinicaltrials.gov

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