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RecruitingNCT04848623CoLive VoiceUpdated Sep 15, 2026

Identification of Vocal Biomarkers to Monitor the Health of People With a Chronic Disease

An observational study in Chronic Disease, sponsored by Luxembourg Institute of Health. Recruiting at 1 site in Luxembourg. Open to participants aged 15 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-09-15.

Sponsored by Luxembourg Institute of Health · Observational

Study type
Observational
Model
Other
Time perspective
Cross-sectional
Enrollment
50,000
Ages
15 Years and older
Sex
All
01

Study summary

The CoLive Voice research project aims to identify vocal biomarkers of severe conditions and frequent health symptoms. The project is based on digital technologies and statistical algorithms. This is an international anonymous survey where vocal recordings are collected simultaneously with large validated clinical and epidemiological data, in the context of various chronic diseases or frequent health symptoms in the general population.

Read the detailed description

With the objective of using vocal biomarkers for diagnosis, risk prediction/stratification and remote monitoring of various clinical outcomes and symptoms, there is a major need to develop surveys where audio data and clinical, epidemiological and patient-reported outcomes data are collected simultaneously.

The objectives of CoLive Voice are:

  • To launch an international anonymized survey where vocal recordings are associated with large validated clinical and epidemiological data, in the context of various chronic diseases or frequent health symptoms in the general population
  • To extract audio features and train supervised machine learning models to identify key candidate vocal biomarkers of the aforementioned chronic conditions or related symptoms.

Participants will be recruited online and will complete the survey using a web application.

They will first answer a detailed questionnaire on their health status and then do 5 different voice records:

  1. read a 30 sec prespecified text (from the Human Rights Declaration),
  2. sustain voicing the vowel /aaaaaa/ as long and as steady as they can at a comfortable loudness
  3. cough 3 times
  4. breath in and out deeply 3 times
  5. Count from 1 to 20 at a normal speed

Vocal records will be pre-processed and converted into features, meaning the most dominating and discriminating characteristics of a vocal signal. Following the selection of features, machine or deep learning algorithms will be trained to automatically predict or classify the clinical, medical or epidemiological outcomes of interest, from vocal features alone or in combination with other health-related data.

02

Conditions studied

  • Chronic Disease

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Keywords

  • vocal biomarker
  • digital biomarker
  • digital health
  • artificial intelligence
  • telemonitoring
  • medical devices
  • precision health digital biomarker
03

Who can participate

Ages eligible
15 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

Adult and adolescent above 15 years, regardless of their health status and their residence country.

Inclusion criteria

  • Adolescents and adults > 15 years
  • With or without health conditions
  • From all countries

Exclusion criteria

Exclusion Criteria:

  • Children \< 15 years
04

Study design

Observational model
Other
Time perspective
Cross-sectional
Enrollment
50,000 participants (estimated)
Patient registry
No
05

What researchers measure

Primary outcomes

  1. Stress

    Patient reported outcome

    Time frame: At baseline

Secondary outcomes

  1. Fatigue

    Patient reported outcome using the fatigue severity scale (FSS). Minimum value =1, max value = 7 ; 7 is the highest level of fatigue

    Time frame: At baseline

  2. Hypertension

    Patient reported outcome

    Time frame: At baseline

  3. Diabetes

    Patient reported outcome

    Time frame: At baseline

  4. Migraine

    Patient reported outcome

    Time frame: At baseline

  5. Covid-19

    Patient reported outcome

    Time frame: At baseline

  6. Overall pain

    Patient reported outcome

    Time frame: At baseline

  7. Respiratory problems

    Patient reported outcome

    Time frame: At baseline

  8. Level of quality of life

    Patient reported outcome

    Time frame: At baseline

06

Study locations

1 of 1 sites recruiting
  • Luxembourg Institute of Health
    Luxembourg, Luxembourg
    • Aurelie Fischer, MS · Contact · colivevoice@lih.lu · 00352 621328591
    • Guy Fagherazzi, PhD · Principal investigator
    Recruiting
07

References and documents

Publications

  • Elbeji A, Pizzimenti M, Aguayo G, Fischer A, Ayadi H, Mauvais-Jarvis F, Riveline JP, Despotovic V, Fagherazzi G. A voice-based algorithm can predict type 2 diabetes status in USA adults: Findings from the Colive Voice study. PLOS Digit Health. 2024 Dec 19;3(12):e0000679. doi: 10.1371/journal.pdig.0000679. eCollection 2024 Dec. PubMed 39700066 ↗
08

Registry details

Key details

Study ID
NCT04848623
Lead sponsor
Luxembourg Institute of Health
Responsible party
Sponsor
First posted
Apr 19, 2021
Start date
Jun 26, 2021
Primary completion
May 1, 2031 (estimated)
Completion
May 1, 2031 (estimated)
Last update
Sep 15, 2026

Study contacts

Aurelie Fischer, MSc
Contact
aurelie.fischer@lih.lu
00352621328591
Guy Fagherazzi, PhD
principal investigator · LIH

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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