Clinical trial NCT05340933: Voice, Dyspnea and Acute Respiratory Failure
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
Overall status: WITHDRAWN
Phase: NA
Conditions: Acute Respiratory Diseases
Keywords: Acute respiratory failure
pneumonia
Chronic obstructive pulmonary desease
exacerbation
COVID-19 pneumonia
dyspnea
speech, voice analysis
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2022-04-22
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.

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

Primary outcomes:
measure: Characterize voice analysis as a biomarker of respiratory status and its evolution in patients hospitalized in pneumology using machine learning algorithmshospitalized in pneumology
timeFrame: 1 month
Secondary outcomes:
measure: Correlation of the used of algorithms based on voice and medical diagnosis.
timeFrame: 1 month
Other outcomes:
Locations:
city: Paris
country: France
facility: Departement of Respiratory Medicine , Pitié-Salpêtrière Hospital
Study officials:
affiliation: Assistance Publique - Hôpitaux de Paris
name: Thomas SIMILOWSKI, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: