NCT06132048 A Usability Validation of the MuCopilot Mobile Application, a Digital Tool for the Unsupervised Objective Assessment of Cystic Fibrosis
| NCT ID | NCT06132048 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Ad scientiam |
| Condition | Cystic Fibrosis |
| Study Type | INTERVENTIONAL |
| Enrollment | 17 participants |
| Start Date | 2024-07-01 |
| Primary Completion | 2024-07-15 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 17 participants in total. It began in 2024-07-01 with a primary completion date of 2024-07-15.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility Criteria
Inclusion Criteria: * Aged ⩾ 18 years old * Patients diagnosed with cystic fibrosis * Enrolled in or benefiting of a Social Security program * Having read the information sheet and signed the informed consent form * Owning a personal smartphone which version is above 14 for IOS and 8 for Android included with a good internet connexion * Able to read French and understand pictograms on a smartphone app Exclusion Criteria: * History of lung transplantation * Pregnant women and women who are breastfeeding * Any medical condition that could interfere with the proper conduct and results of the study (clinician's judgement) * Illiterate in French * Inability to use a smartphone or MuCopilot application * Person under legal protection (including guardianship or curatorship)
Frequently Asked Questions
Who can join the NCT06132048 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Cystic Fibrosis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06132048 currently recruiting?
Yes, NCT06132048 is actively recruiting participants. Visit ClinicalTrials.gov or contact Ad scientiam to inquire about joining.
Where is the NCT06132048 trial being conducted?
This trial is being conducted at Rouen, France.
Who is sponsoring the NCT06132048 clinical trial?
NCT06132048 is sponsored by Ad scientiam. The trial plans to enroll 17 participants.