NCT06099145

Clinical and Medico-economic Validation of the HEPHAI Solution.

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: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 238 (estimated)
• Sponsor: Hephai · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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 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

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", 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.

Conditions

• Asthma COPD

Interventions

Type	Name	Description
DEVICE	Hephaï	Used of the HEPHAI medical device as a tool to improve the delivery of inhaled treatments for asthma and COPD

Timeline

• Start date: 2023-09-19
• Primary completion: 2024-09-30
• Completion: 2024-09-30
• First posted: 2023-10-25
• Last updated: 2023-10-25

Locations

5 sites across 1 country: France