Clinical studies
Our clinical studies are designed to validate vocal biomarkers and accelerate their adoption in respiratory care
2021-2022
COVID+VOICES
We began clinical data collection with the Laboratoire National de Santé in Luxembourg and the Turin Local Health Authority. We collected one voice recording per participant, together with health, wellbeing, and COVID-19 information. These studies helped us develop the first version of our audio-acquisition engine, introduce quality controls, and establish early proofs of concept for vocal biomarkers.
1495 participants enrolled
COVID-19
Audio acquisition engine
2023
CARE study
During a clinical study at Humanitas Research Hospital, we collected six voice recordings per participant across different respiratory health conditions, together with symptoms, smoking status, physical activity, demographics, spirometry results, and clinician-assessed asthma diagnoses. This study advanced our vocal biomarker models and supported the development of the Airlyn app.
40 participants enrolled
Asthma
1st proof of concept
2024–2025
VERA and AIPU studies
With Humanitas and San Camillo Forlanini Hospital, we expanded data collection to support COPD detection from a single voice recording. Each recording was linked to clinical, demographic, lifestyle, symptom, and spirometry data.
1900 participants enrolled
COPD, Asthma, smoking
Prototype
2026–2027
Pivotal study in the Netherlands
We plan to validate VoiceMed Check for COPD in real-world, unsupervised settings, with recruitment through GPs and pharmacies. Results will be compared with diagnoses confirmed by at least two specialists. The study will support the transition of the prototype into Class IIa medical device software under the EU MDR. The intended purpose has been drafted, a notified body identified, and a legal-manufacturer partner with an established Quality Management System selected.
500 participants planned
COPD
CE mark
2026–2028
VOICE and BREATH studies
We are conducting 12-month monitoring studies with San Camillo Forlanini Hospital and Policlinico Umberto I. Multiple daily voice recordings are combined with symptoms, vital signs, therapy changes, medical visits, and emergency department use. The goal is to predict COPD exacerbations by analysing changes in voice over time and to develop the VoiceMed Wellbeing app.
500 participants planned
COPD