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COVID-19: Early Detection of Worsening by Voice and Respiratory Pattern Characteristics

COVID-19: Early Detection of Worsening by Voice and Respiratory Pattern Characteristics

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05892549
Acronym
COVOICE
Enrollment
1188
Registered
2023-06-07
Start date
2023-06-12
Completion date
2026-07-31
Last updated
2023-06-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

COVID-19, Sars-CoV-2 Infection

Keywords

Voice

Brief summary

In some clinical forms of COVID-19, an uncontrolled hyper-inflammatory reaction known as a cytokine storm appears abruptly, around day 7, and is associated with rapid respiratory deterioration, requiring hospitalization in an intensive care unit (ICU). At present, although risk factors for this severe form have been described, there are no validated criteria for determining which individual patients will develop this aggravation. The study of respiratory sounds (amplitude, frequency, ...) has made it possible in other respiratory pathologies (e.g., chronic obstructive pulmonary disease) to predict exacerbations several days in advance. Having a predictive respiratory pattern for worsening in COVID-19 would make it possible to anticipate the need for intensive care hospital beds, by means of a tool easily available on a mobile phone.

Interventions

DEVICECOVOICE application use - initial

Recording (only once) of sound related to respiratory movements, coughing and voice using a mobile phone application

DEVICECOVOICE application use - follow-up

Daily recording of sound related to respiratory movements, coughing and voice using a mobile phone application. Duration: up to 30 days

Sponsors

Direction Centrale du Service de Santé des Armées
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum

Inclusion criteria

* French speaking * Affiliated to a social security system * Owning a mobile phone capable of accessing the COVOICE application

Exclusion criteria

* Incapable adults * People deprived of their liberty * People under administrative or judicial supervision * Patients intubated or hospitalized in intensive care unit

Design outcomes

Primary

MeasureTime frame
Sensitivity of the respiratory pattern demonstrated in the COVID patients who experienced respiratory worseningThrough study completion (36 months)
Specificity of the respiratory pattern demonstrated in the COVID patients who experienced respiratory worseningThrough study completion (36 months)

Countries

France

Contacts

Primary ContactHubety NIELLY, MD
hubert.nielly@intradef.gouv.fr143985479

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026