Development of Voice Biomarkers of Frequent COVID-19 and Long Covid-related Symptoms Based on Data From Users of the Long COVID Companion App
NCT ID: NCT07156994
Last Updated: 2025-12-08
Study Results
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Basic Information
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NOT_YET_RECRUITING
300 participants
OBSERVATIONAL
2025-12-15
2028-09-30
Brief Summary
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The development of vocal biomarkers of Long COVID-related symptoms could improve the remote monitoring of the health status of people affected by this disease.
The LIH developed the Long COVID Companion (LCC) app in collaboration with the ApresJ20 Long COVID patient association in France to support patients in their daily lives. LCC app users will be invited to participate in this study to collect voice recordings at the same time as health-related data.
The objectives of this study are:
Primary objective: To develop vocal biomarker candidates for the main Long COVID symptoms (fatigue, brain fog, respiratory problems, sleep issues, stress, anxiety,..) in a population of people with Long COVID.
Secondary objectives:
* to assess the intra-individual longitudinal evolution of voice characteristics of people with LC
* to assess app usability and acceptability in the long-term.
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Detailed Description
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People with Long COVID (PWLC) present complaints such as tachycardia, extreme fatigue, dyspnea, and inability to perform daily physical tasks. More than 200 symptoms have been associated with Long COVID, and multiple organs are affected. Our previous work showed that 59% of COVID-19-infected people from the PrediCOVID cohort study reported 1 or more persisting symptom(s) after one year. The number of persisting symptoms increased with the initial disease severity, and the quality of life of those participants was notably impacted by sleep disorders (54%) and compromised respiratory function (12.9%). Nonetheless, individuals with an initially asymptomatic or mild form of COVID-19 infection could also be affected.
Long COVID care, as for other chronic diseases, should align with the concept of minimally disruptive medicine, aiming for a reduced burden on patients' lives while maximizing health outcomes. PWLC frequently have several healthcare professionals in charge of different aspects of their care, with many appointments and travels to manage. They are also regularly asked to complete long standardized questionnaires or scales to evaluate their symptoms, which generates an avoidable burden on their lives if care is not coordinated. The development of innovative methods to integrate multiple Patient Report Outcomes in a portable, versatile way, to reduce travels for medical care, and overall for remote health's monitoring is therefore of the highest importance.
Few existing apps that could meet the needs of PWLC already exist, such as "Visible" or "Living With". However, these apps are only available in the US and in the UK, respectively. Furthermore, the "Living with" app is available only by invitation. This limits their availability for PWLC in Europe. Some other apps designed for other chronic conditions, like myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS) Pacing app, are also used by some PWLC to manage their daily energy levels. However, these apps do not fully meet the specific needs of PWLC, and are only available in specific countries, in English, and some of them only on the iOS operating system, which restricts their potential use.
Voice is a promising candidate increasingly used in mobile health (mHealth) interactions in chronic diseases. Voice is an easy and cheap medium to collect and can be easily integrated into a device like a smartphone, now widely used by people of different ages and education levels. It can be used for vocal biomarker assessment as new clinical endpoints for relevant symptoms. Vocal biomarker candidates have already been identified by the Deep Digital Phenotyping (DDP) research team, based on data from the PrediCOVID cohort study, with performances above 80% to detect fatigue, loss of taste and smell, and symptomatic status in COVID-19-infected people. However, further progress is required before these vocal biomarkers can be used in clinical practice. New vocal biomarkers of global health status or of other symptoms need to be developed to allow a more personalized monitoring of PWLC.
The LIH developed the Long COVID Companion app based on the results of UpcomingVoice co-design study and in collaboration with the ApresJ20 Long COVID patient association in France. The app is the result of a participative process involving patients and healthcare professionals in charge of PWLC patients. App users can monitor their health and symptoms on a daily basis or at the frequency they want. App also offers the possibility to complete a daily life and a medical diary, a voice journaling, and to generate PDF reports with graphical visualization of symptom evolution. A new module dedicated to research with standardized voice recordings has been integrated in the app for the users who will take part in the present study The app was released in April 2024 and has more than 1700 users as of the end of March 2025.
It is of highest importance to assess the evolution of health of PWLC for a better understanding of the disease. Results will allow the development of personalized monitoring strategies by identifying vocal biomarkers of Long COVID symptoms and of the global health of PWLC.
As fatigue is the most frequent and impairing symptom of PWLC it is crucial to better understand the drivers of fatigue and to develop monitoring strategies.
The objectives of this study are :
Primary objective: To develop vocal biomarker candidates for the main Long COVID symptoms (fatigue, brain fog, respiratory problems, sleep issues, stress, anxiety,..) in a population of people with Long COVID.
Secondary objectives:
* to assess the intra-individual longitudinal evolution of voice characteristics of people with LC
* to assess app usability and acceptability in the long-term.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Long Covid Companion (LCC) app users
Study participation will consist in a follow-up of maximum 36 months after the signature of the electronic informed consent form. The participants will be invited to use the app in the manner they want, in terms of frequency and functionalities used.
Participants who were already using the app before signing the study informed consent form will be asked if they agree to the use of the data previously collected between the account creation and the informed consent signature for the study.
In addition, study participants will be invited to do regular standardized voice recordings (at the same time as their regular health evaluation) and to complete the symptom questionnaires at the same time. Very short questions (Ecological Momentary Assessments), followed by one standardized voice recording, will also be sent during the first 8 days after signature of the study informed.
No Intervention: Observational Cohort
Participants will be followed digitally using the LCC app. They will complete questionnaires about their health status and do voice recordings on their own rhythm during the entire study duration.
Interventions
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No Intervention: Observational Cohort
Participants will be followed digitally using the LCC app. They will complete questionnaires about their health status and do voice recordings on their own rhythm during the entire study duration.
Eligibility Criteria
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Inclusion Criteria
* Male or female
* People with persisting symptoms related to COVID-19 (With Long COVID diagnosis or not)
* Adequate understanding of one of the study languages (English, French, German)
* Electronically signed informed consent form
18 Years
ALL
No
Sponsors
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Luxembourg Institute of Health
OTHER_GOV
Responsible Party
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Locations
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LIH
Strassen, , Luxembourg
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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EVO-LC
Identifier Type: -
Identifier Source: org_study_id
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