NCT07156994

Brief Summary

The LIH DDP research team focuses its research topics on vocal biomarkers and Long COVID, among others. Voice is indeed a promising tool to monitor health, as it contains many information on our health and is easy to collect. 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.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
300

participants targeted

Target at P75+ for all trials

Timeline
29mo left

Started Dec 2025

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress14%
Dec 2025Sep 2028

First Submitted

Initial submission to the registry

September 2, 2025

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 5, 2025

Completed
3 months until next milestone

Study Start

First participant enrolled

December 15, 2025

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2028

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2028

Last Updated

December 8, 2025

Status Verified

August 1, 2025

Enrollment Period

2.8 years

First QC Date

September 2, 2025

Last Update Submit

December 1, 2025

Conditions

Keywords

Long COVIDVocal biomarkerssymptoms

Outcome Measures

Primary Outcomes (3)

  • Fatigue level

    Level of fatigue will be assessed regularly using a 0-5 likert scale. Participants will complete these questionnaires when they want during the follow-up.

    From enrollment until 24 months after

  • Fatigue level

    Level of fatigue will be assessed regularly using FSS9 questionnaire. Participants will complete these questionnaires when they want during the follow-up.

    From enrollment until 24 months after

  • Voice features

    * Source features (e.g., jitter, shimmer) reflecting the origin of voice production * Formant features (e.g., F1, F2, F3 frequencies, bandwidths) representing resonant frequencies of vocal and nasal tracts * Spectral features (e.g., centroid, MFCCs, flatness) capturing frequency distribution at specific moments * Prosody features (e.g., pitch, intensity, speech rate, pause duration) describing rhythm and intonation

    From inclusion until 24 months after

Study Arms (1)

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.

Other: No Intervention: Observational Cohort

Interventions

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.

Long Covid Companion (LCC) app users

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

All adult people with suspected Long COVID can participate in this study. As the study is completely digital, there are no restriction in terms of living country. All the users of the Long COVID Companion app will be invited to participate in the study (by email or directly in the app). Recruitment will also be done by communications on social media, and by distributing study flyers in the waiting rooms of Long COVID consultations network. Participants to the PrediCOVID study who accepted to be recontacted will also be invited. Information regarding the study will also be disseminated to all people with Long COVID in the database of the Long COVID consultation network in Luxembourg.

You may qualify if:

  • Adult (≥18 years old)
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

LIH

Strassen, L-1445, Luxembourg

Location

MeSH Terms

Conditions

Post-Acute COVID-19 Syndrome

Condition Hierarchy (Ancestors)

COVID-19Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract DiseasesPost-Infectious DisordersChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Central Study Contacts

Aurélie FISCHER, PhD

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 2, 2025

First Posted

September 5, 2025

Study Start

December 15, 2025

Primary Completion (Estimated)

September 30, 2028

Study Completion (Estimated)

September 30, 2028

Last Updated

December 8, 2025

Record last verified: 2025-08

Data Sharing

IPD Sharing
Will not share

Locations