Clinical studies portfolio
Since 2021, VoiceMed has developed a growing portfolio of clinical studies across multiple countries.
Our research is designed to build high-quality datasets, investigate vocal biomarkers, and assess their performance against clinically relevant benchmarks.
Our research is designed to build high-quality datasets, investigate vocal biomarkers, and assess their performance against clinically relevant benchmarks.
2021-2022 · Completed
COVID+VOICES
LNS, Luxembourg and ASL of Turin, Italy
This study explored the use of voice data in relation to COVID-19 and general health. Voice recordings were combined with information about participants’ health, wellbeing, and COVID-19 status, with each participant completing the recording activity once. The study supported the development of our audio-acquisition engine, recording-quality controls, and early research into vocal biomarkers.
1495 participants enrolled
COVID-19
Audio acquisition engine
2023 · Completed
CARE study
Humanitas Research Hospital, Italy
This study investigated how vocal characteristics vary in relation to respiratory health and airway responsiveness. During this study, participants underwent a methacholine challenge and completed six voice-recording activities at different stages of the procedure. Voice recordings were analysed alongside spirometry results, symptoms, smoking status, physical activity, demographic information, and clinician-assessed asthma diagnoses. The study provided our first proof of concept that variations in lung function can be analysed through vocal biomarkers.
40 participants enrolled
Asthma
1st proof of concept
2024–2025 · Completed
VERA and AIPU studies
San Camillo Forlanini and Humanitas hospitals, Italy
These studies evaluated the ability of vocal biomarkers to identify COPD from a single voice-recording activity. Each participant completed one recording, and the result generated by VoiceMed Check for COPD was compared with the physician-assessed diagnosis used as the clinical reference standard. This comparison enabled us to calculate the sensitivity and specificity of the prototype. Additional information, including diagnosis of other diseases, spirometry results, symptoms, demographic characteristics, smoking history, and lifestyle data, was also collected to support the development of future vocal biomarkers and other respiratory-health applications.
1900 participants enrolled
COPD, Asthma, smoking
Prototype
2026–2027 · Ongoing
Pivotal study in the Netherlands
General Practitioners, Netherlands
This study is designed to validate the performance of VoiceMed Check for COPD in an unsupervised setting. Each participant will complete one voice-recording activity, and the result generated by VoiceMed Check will be compared with the final diagnosis established through the standard clinical diagnostic pathway. This comparison will allow us to assess the sensitivity and specificity of VoiceMed Check for COPD against the physician-confirmed diagnosis. The study is intended to support the clinical evaluation and regulatory development of the software as a Class IIa medical device under the EU MDR.
500 participants planned
COPD
CE mark
2026–2028 · Ongoing
VOICE and BREATH studies
Policlinico Umberto I and San Camillo Forlanini hospitals, Italy
These studies investigate whether changes in voice over time may help identify an increased risk of COPD exacerbation. Daily voice recordings are combined with symptoms, vital signs, treatment changes, medical visits, and emergency-department use, with each participant recording for 365 days. The studies support the development of VoiceMed Predict for COPD.
500 participants planned
COPD