NCT06132048

A Usability Validation of the MuCopilot Mobile Application, a Digital Tool for the Unsupervised Objective Assessment of Cystic Fibrosis

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 17 (estimated)
• Sponsor: Ad scientiam · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The study aims to assess the usability and safety of use of MuCopilot, a smartphone application that measures objective data on lung function, global exercise capacity and patient reported outcomes of patients with Cystic Fibrosis (CF). These data are collected during unsupervised digital tests performed in the patient's home environment between consultations. The primary objective is to validate the usability and safety of use, in order to assure that the patients use the medical device as intended without any unacceptable error of use and without unacceptable risk. The study will include 17 CF patients and will be conducted in France. They will participate in 1 inclusion visit and 1 visit in-clinic (1h30). Patients will be able to download the free MuCopilot mobile application. During the visit, patients will complete 3 digital tests in order to monitor CF functions (cough, dyspnea \& walking) and 1 symptom questionnaire.

Conditions

• Cystic Fibrosis

Interventions

Type	Name	Description
DEVICE	MuCopilot mobile application	MuCopilot is a software as medical device with three digital tests, to measure patient's with CF, lung function, global exercise capacity and a questionnaire to address CF symptoms and impacts on some aspects of patient's life

Timeline

• Start date: 2024-07-01
• Primary completion: 2024-07-15
• Completion: 2025-02-01
• First posted: 2023-11-15
• Last updated: 2025-01-29

Locations

1 site across 1 country: France