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Not Yet Recruiting NCT07665229

VOCAL BIOMARKERS FOR HEALTH MONITORING: AN OPEN LONGITUDINAL HYBRID COHORT STUDY

Conditions: Any Condition

Sex: All
Ages: 18 Years – N/A
Healthy volunteers: Yes
Enrollment: 3700
Sponsor: Luxembourg Institute of Health

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.

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View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT07665229). StuddyBuddy aggregates publicly available trial information.