Acute Respiratory DiseasesLocuPnée-HNCT05340933
Voice, Dyspnea and Acute Respiratory Failure
A study testing Voice registration in people with Acute Respiratory Diseases, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Respiratory Diseases
- What is being tested?
- Voice registration
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteFrance
- Study dates
- 1 Jun 2025to 1 Sep 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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;
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
France1 site
Departement of Respiratory Medicine , Pitié-Salpêtrière Hospital
Paris, France, 75013
About this study
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
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.
Read the 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.
- Conditions
- Acute Respiratory Diseases
- Being tested
- Voice registration
- Keywords
- Acute respiratory failure, pneumonia, Chronic obstructive pulmonary desease, exacerbation, COVID-19 pneumonia, dyspnea, speech, voice analysis
- Medical subject headings
- Pneumonia, Dyspnea, Speech
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Voice registrationOther
Voice registration
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Experimental | intervention correspond to the voice registration Receives: Other: Voice registration |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 month
Secondary outcomes (1)
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.
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2022
- Study start1 Jun 2025 (estimated)
- Primary completion1 Feb 2026 (estimated)
- Study completion1 Sep 2026 (estimated)
Why it stopped: study discontinued
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Respiratory DiseasesStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Thomas SIMILOWSKI, MD, PhD, Principal investigator, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05340933
- Sponsor's protocol ID
- APHP211210
- Acronym
- LocuPnée-H
- Status last verified
- Sep 2024
- First submitted
- 10 Jan 2022
- Last updated
- 2 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05340933
- Acronym / sponsor ID
- LocuPnée-H / APHP211210
- Conditions
- Acute Respiratory Diseases
- Keywords
- Acute respiratory failure, pneumonia, Chronic obstructive pulmonary desease, exacerbation, COVID-19 pneumonia, dyspnea, speech, voice analysis
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: study discontinued
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- 1 Jun 2025 (estimated)
- Primary completion
- 1 Feb 2026 (estimated)
- Study completion
- 1 Sep 2026 (estimated)
- First posted
- 22 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | Experimental | Other: Voice registrationintervention correspond to the voice registration |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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;
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Voice registrationVoice registration | Other | Arm 1 |
Primary outcome
Characterize voice analysis as a biomarker of respiratory status and its evolution in patients hospitalized in pneumology using machine learning algorithmshospitalized in pneumology
Time frame: 1 month
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.
1 secondary outcome
Correlation of the used of algorithms based on voice and medical diagnosis.
Time frame: 1 month
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Thomas SIMILOWSKI, MD, PhD principal investigator
Assistance Publique - Hôpitaux de Paris
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Voice registration in people with Acute Respiratory Diseases, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 2 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Characterize voice analysis as a biomarker of respiratory status and its evolution in patients hospitalized in pneumology using machine learning algorithmshospitalized in pneumology (time frame: 1 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Oct 2024.