NCT07665229 VOCAL BIOMARKERS FOR HEALTH MONITORING: AN OPEN LONGITUDINAL HYBRID COHORT STUDY
| NCT ID | NCT07665229 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Luxembourg Institute of Health |
| Condition | Any Condition |
| Study Type | OBSERVATIONAL |
| Enrollment | 3,700 participants |
| Start Date | 2026-09-01 |
| Primary Completion | 2031-05 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 3,700 participants in total. It began in 2026-09-01 with a primary completion date of 2031-05.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Voice could be considered a new vital sign in the future, being collected in routine care and complement other medical assessments. Vocal biomarkers (VB) are voice characteristics that are specific to a disease or symptom. They can be utilized in clinical practice for remote disease monitoring, screening for diseases, or in clinical research as secondary endpoints to evaluate the efficacy of a treatment or intervention. They can also be used during enhanced consultations to screen for diseases or monitor the progression of a chronic disease, in services to identify at-risk patients, and at home to track patients' symptoms and general health status between consultations. Despite the potential of VB and many progresses, few have reached the stage of use in clinical routine. At LIH, the Deep Digital Phenotyping research lab gained experience in the voice-related research field since 2019, with the implementation of methodological tools to collect and pre-process voice recordings, and with the development of vocal biomarker candidates in several therapeutic domains or symptoms (Type 2 diabetes, fatigue, COVID-19 and Long COVID, respiratory health, mental health, etc.) VB is an early-stage research topic; one needs to accelerate the development, validation and integration of vocal biomarkers for personalized medicine and innovative tools - both for clinical practice and remote patient monitoring. Until now, VB candidates have been developed disease by disease, and there is a lack of data on the influence of concomitant diseases on voice signatures. Therefore, the next vital step to improve vocal biomarkers and assess their specificity is to compare them with both control groups, those without the disease, and those with other diseases. The study is a cohort of adult people attending one of the hospitals in Luxembourg, either for an hospitalization, a consultation, or a simple visit, regardless of their health conditions. Study will be conducted in French, English, German, and Portuguese which are the most frequent languages in Luxembourg. Study participants will be followed up over a 5 years period of time, with on-site study visits in study booths installed in the different hospitals in Luxembourg and at-home monitoring in-between visits, using a smartphone app to collect study data. During both study visits and at-home monitoring voice recordings will be collected together with health data. This will allow to understand how voice evolves with time in a given individual, and to identify VB specific to diseases like diabetes, or to symptoms common to several chronic diseases like fatigue or mental health problems.
Eligibility Criteria
Inclusion Criteria: * Adults ≥ 18 years. * Able to understand the study, provide informed consent and comply with study procedures (with reasonable accommodations as needed). * Speaks one of the study languages (FR/EN/DE/PT). * Owns a smartphone compatible with the study app. Exclusion Criteria: * \- Acute clinical instability at inclusion (e.g., need for immediate medical care, severe respiratory distress, hospitalized patients not allowed to go out of their room) where study procedures could interfere with care. * Any other condition that, in the judgement of the Medical PI or delegated qualified staff, would place the participant at unreasonable risk or prevent meaningful participation, despite accommodations.
Contact & Investigator
Guy Fagherazzi, PhD
PRINCIPAL INVESTIGATOR
Luxembourg Institute of Health
Frequently Asked Questions
Who can join the NCT07665229 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Any Condition. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07665229 currently recruiting?
Yes, NCT07665229 is actively recruiting participants. Contact the research team at aurelie.fischer@lih.lu for enrollment information.
Where is the NCT07665229 trial being conducted?
This trial is being conducted at Luxembourg, Luxembourg.
Who is sponsoring the NCT07665229 clinical trial?
NCT07665229 is sponsored by Luxembourg Institute of Health. The principal investigator is Guy Fagherazzi, PhD at Luxembourg Institute of Health. The trial plans to enroll 3,700 participants.