Voice, Dyspnea and Acute Respiratory Failure (LocuPnée-H)
Primary Purpose
Acute Respiratory Diseases
Status
Not yet recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Voice registration
Sponsored by
About this trial
This is an interventional diagnostic trial for Acute Respiratory Diseases focused on measuring Acute respiratory failure, pneumonia, Chronic obstructive pulmonary desease, exacerbation, COVID-19 pneumonia, dyspnea, speech, voice analysis
Eligibility Criteria
Inclusion Criteria:
- patients hospitalised in the Pitié-Salpêtrière Pneumology Department with an acute respiratory illness (pneumonia of any cause, COVID pneumonia depending on the epidemic context, COPD decompensation, etc);
- whose condition allows conversational exchanges with the nursing staff within the framework of usual care;
- adults, not protected;
- understand and speak French fluently;
- affiliated to the social security system;
- having read and understood the information leaflet;
- do not object to the use of their data;
Exclusion Criteria:
- a clinical condition on admission that is too severe to allow the patient to answer the usual questions of the anamnestic and clinical examination
- patients with uncorrected hearing problems
- patients with neurological, otorhinolaryngological or psychiatric pathology
Sites / Locations
- Departement of Respiratory Medicine , Pitié-Salpêtrière Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Arm 1
Arm Description
intervention correspond to the voice registration
Outcomes
Primary Outcome Measures
Characterize voice analysis as a biomarker of respiratory status and its evolution in patients hospitalized in pneumology using machine learning algorithmshospitalized in pneumology
machine learning algorithms trained on the audio database obtained from patients discussion with medical staff. Voice parameters: respiratory rythms and intensity, and articulatory performances, will be extracted from voice recording, combined and analysed by the algorithms.
Secondary Outcome Measures
Correlation of the used of algorithms based on voice and medical diagnosis.
Medical diagnosis based on physiological parameters (heart rate (bpm) ; oxygen saturation (%) ; respiratory rate (cycle/min)) will be carried out in the routine care and correlated with the algorythms results.
Full Information
NCT ID
NCT05340933
First Posted
January 10, 2022
Last Updated
August 21, 2023
Sponsor
Assistance Publique - Hôpitaux de Paris
1. Study Identification
Unique Protocol Identification Number
NCT05340933
Brief Title
Voice, Dyspnea and Acute Respiratory Failure
Acronym
LocuPnée-H
Official Title
Speech and Voice as Biomarkers of Physiological Status in Patients With Respiratory Diseases: Proof of Concept in Acute Respiratory Disease Managed in a Pulmonary Hospital
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
June 1, 2024 (Anticipated)
Primary Completion Date
February 1, 2025 (Anticipated)
Study Completion Date
September 1, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Assistance Publique - Hôpitaux de Paris
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Breathing is an automatic vital function that has the peculiarity of being controllable voluntary for actions other than breathing. Speech production is a characteristic example of use of the respiratory system for nonrespiratory purposes. A healthy respiratory system is necessary for speech to be adequately produced and modulated. In patients with respiratory diseases, it becomes difficult to interfere with an automatic control of breathing that is intensely active to compensate for the respiratory deficience. Speech production is impeded, and, reciprocally, speech can generate dyspnea. This study explores the hypothesis that longitudinal changes in speech characteristics will parallel the clinical evolution of acute respiratory episodes. The aim is to validate such changes as prognostic indicators, in the perspective of future telemedicine applications. The hypothesis tested is that of an association between :
vocal abnormalities at inclusion (assessed in relation to known data within a normal population (database of holy subjects already constituted) and the initial clinical severity (assessed according to the usual clinical and gasometric criteria):
the evolution of vocal abnormalities during the stay and the clinical evolution.
Detailed Description
In the conceptual framework describe in the "brief summary" section of this document, this observational longitudinal monocentric study will include consecutive patients admitted in a specialised respiratory medicine ward for acute respiratory episodes. Any such episode will be considered be it "de novo" or complicating an underlying chronic respiratory disease. Vocal recordings will be performed daily, and will be analysed according to standard in the fields. Clinical parameters will also be recorded daily (vital signs, treatment intensity, outcome -including requirement for treatment intensification, transfer to the ICU, death, discharge to rehabilitation facility, discharge to home). The clinical follow-up and the vocal follow-up will be confronted to determine if voice analysis has an intrinsic prognostic value, alone, or in combination with clinical signs.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Respiratory Diseases
Keywords
Acute respiratory failure, pneumonia, Chronic obstructive pulmonary desease, exacerbation, COVID-19 pneumonia, dyspnea, speech, voice analysis
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
150 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Arm 1
Arm Type
Experimental
Arm Description
intervention correspond to the voice registration
Intervention Type
Other
Intervention Name(s)
Voice registration
Intervention Description
Voice registration
Primary Outcome Measure Information:
Title
Characterize voice analysis as a biomarker of respiratory status and its evolution in patients hospitalized in pneumology using machine learning algorithmshospitalized in pneumology
Description
machine learning algorithms trained on the audio database obtained from patients discussion with medical staff. Voice parameters: respiratory rythms and intensity, and articulatory performances, will be extracted from voice recording, combined and analysed by the algorithms.
Time Frame
1 month
Secondary Outcome Measure Information:
Title
Correlation of the used of algorithms based on voice and medical diagnosis.
Description
Medical diagnosis based on physiological parameters (heart rate (bpm) ; oxygen saturation (%) ; respiratory rate (cycle/min)) will be carried out in the routine care and correlated with the algorythms results.
Time Frame
1 month
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
patients hospitalised in the Pitié-Salpêtrière Pneumology Department with an acute respiratory illness (pneumonia of any cause, COVID pneumonia depending on the epidemic context, COPD decompensation, etc);
whose condition allows conversational exchanges with the nursing staff within the framework of usual care;
adults, not protected;
understand and speak French fluently;
affiliated to the social security system;
having read and understood the information leaflet;
do not object to the use of their data;
Exclusion Criteria:
a clinical condition on admission that is too severe to allow the patient to answer the usual questions of the anamnestic and clinical examination
patients with uncorrected hearing problems
patients with neurological, otorhinolaryngological or psychiatric pathology
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Thomas SIMILOWSKI, MD, PhD
Phone
+33(0)669767252
Email
thomas.similowski@upmc.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Capucine MORELOT-PANZINI, MD, PhD
Phone
+33 (0)6 73 88 22 35
Email
capucine.morelot@upmc.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Thomas SIMILOWSKI, MD, PhD
Organizational Affiliation
Assistance Publique - Hôpitaux de Paris
Official's Role
Principal Investigator
Facility Information:
Facility Name
Departement of Respiratory Medicine , Pitié-Salpêtrière Hospital
City
Paris
ZIP/Postal Code
75013
Country
France
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Thomas SIMILOWSKI, MD, PhD
Phone
+33(0)669767252
Email
thomas.similowski@upmc.fr
First Name & Middle Initial & Last Name & Degree
Capucine MORELOT-PANZINI, MD, PhD
Phone
+33 (0)6 73 88 22 35
Email
capucine.morelot@upmc.fr
12. IPD Sharing Statement
Learn more about this trial
Voice, Dyspnea and Acute Respiratory Failure
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