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Frequency-time Analysis of Pathological Lung Sounds: Detection and Quantification of Pathological Sounds in Patients With Cystic Fibrosis, Pulmonary Fibrosis or COPD (Chronic Obstructive Pulmonary Disease)

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

 No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

 Observational
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • - 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.

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

 NCT06399094
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

 Groupe Hospitalier de la Region de Mulhouse et Sud Alsace
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

 N/A
Principal Investigator Affiliation N/A
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

 Other
Overall Status Not yet recruiting
Countries
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

 Pulmonary Fibrosis, Chronic Obstructive Pulmonary Disease, Cystic Fibrosis
Additional Details

Secondary objectives. The other objectives of this study are : 1. To evaluate the ability to detect changes in lung sounds, following optimization of the time-frequency representation. 2. To evaluate the ability to quantify differences in the severity of the pathological sounds detected using artificial intelligence and a supervised learning method. Conduct of research This is a single-center, non-randomized, open-label study involving 60 male and female patients aged 18 to 65, eligible for a scheduled consultation as part of their usual pathological follow-up (routine care). Lung sound recordings will be made during the same consultation, after obtaining the patient's non-opposition. Recordings will be made using a 3M Littmann© model 3200 electronic stethoscope. The stethoscope works with Eko software, which will be installed on a touch-sensitive tablet or computer, enabling local storage of recorded data. Whatever the patient's pathology, the physician will listen to 10 lung sites defined in the protocol. At least one breath per pulmonary site will be recorded during the consultation. If a patient comes back for a consultation before the end of the recruitment period, a new lung sound recording will be performed.

Arms & Interventions

Arms

: Pulmonary fibrosis

: Chronic Obstructive Pulmonary Disease

: Cystic fibrosis

Interventions

Other: - Lung sound recordings

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.

Contact Information

This trial has no sites locations listed at this time. If you are interested in learning more, you can contact the trial's primary contact:

For additional contact information, you can also visit the trial on clinicaltrials.gov.

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