NCT06399094

Brief Summary

The main objective of the study is to assess the potential of time-frequency representation and analysis of pulmonary sounds collected with an electronic stethoscope, as part of the routine monitoring of patients with cystic fibrosis, COPD or pulmonary fibrosis.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
23

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jul 2024

Geographic Reach
1 country

2 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 26, 2024

Completed
7 days until next milestone

First Posted

Study publicly available on registry

May 3, 2024

Completed
3 months until next milestone

Study Start

First participant enrolled

July 18, 2024

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 30, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 30, 2025

Completed
Last Updated

November 17, 2025

Status Verified

November 1, 2025

Enrollment Period

1.1 years

First QC Date

April 26, 2024

Last Update Submit

November 14, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • Lung sounds visible in their representation as time-frequency images

    Pulmonary sounds will be recorded with an electronic stethoscope at each scheduled visit and processed with artificial intelligence using a supervised learning method.

    At inclusion

Secondary Outcomes (1)

  • Classification of sounds by severity

    At inclusion

Study Arms (3)

Pulmonary fibrosis

Other: Lung sound recordings

Chronic Obstructive Pulmonary Disease

Other: Lung sound recordings

Cystic fibrosis

Other: Lung sound recordings

Interventions

The lung sound recordings will be made during a consultation scheduled as part of the patient's usual follow-up, after obtaining the patient's non-opposition.

Chronic Obstructive Pulmonary DiseaseCystic fibrosisPulmonary fibrosis

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Eligible patients will be recruited during a consultation scheduled as part of the usual follow-up of their pathology in the pneumology department of mulhouse hospital center and strasbourg university hospital center.

You may qualify if:

  • Age ≥ 18 years
  • Suffering from one of the following pathologies: cystic fibrosis, pulmonary fibrosis, COPD
  • Not opposed to participating in the study

You may not qualify if:

  • Person under court protection, guardianship or curatorship
  • Person deprived of liberty by judicial or administrative decision
  • Patient with a history of thoracic surgery, thoracic deformity, heart failure or other relevant illness at the investigator's discretion.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Hôpitaux Universitaire de Strasbourg

Strasbourg, Bas-Rhin, 67000, France

Location

GHRMSA - Hôpital Emile Muller

Mulhouse, Haut-Rhin, 68100, France

Location

MeSH Terms

Conditions

Pulmonary FibrosisPulmonary Disease, Chronic ObstructiveCystic Fibrosis

Condition Hierarchy (Ancestors)

Lung Diseases, InterstitialLung DiseasesRespiratory Tract DiseasesFibrosisPathologic ProcessesPathological Conditions, Signs and SymptomsLung Diseases, ObstructiveChronic DiseaseDisease AttributesPancreatic DiseasesDigestive System DiseasesGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesInfant, Newborn, Diseases

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 26, 2024

First Posted

May 3, 2024

Study Start

July 18, 2024

Primary Completion

August 30, 2025

Study Completion

August 30, 2025

Last Updated

November 17, 2025

Record last verified: 2025-11

Data Sharing

IPD Sharing
Will not share

Locations