Advancing digital voice measures and accelerating their adoption in clinical trials in Chronic Obstructive Pulmonary Disease (COPD) and Heart Failure (HF) 

Chronic Obstructive Pulmonary Disease (COPD) and Heart Failure (HF) are both chronic, progressive diseases that present significant challenges to patients and healthcare providers. COPD, a condition characterized by persistent airflow limitation, often leads to difficulty breathing, frequent exacerbations, and a reduced quality of life. Heart failure, on the other hand, occurs when the heart is unable to pump blood efficiently, resulting in symptoms such as shortness of breath, fatigue, and fluid retention. 

A primary cause of hospitalizations in COPD patients are exacerbations, which are episodes of worsening symptoms. Unfortunately, the majority of these exacerbations are not detected early, leading to delays in treatment and potentially more severe health complications. Early detection and timely intervention are crucial for managing COPD and reducing the risk of frequent hospital admissions. 

​

Heart decompensation occurs when the heart is unable to maintain sufficient cardiac output to meet the body's demands. The hallmark symptom of this condition is fluid retention in the lungs, which is often followed by weight gain, fatigue, and shortness of breath. These symptoms reflect the heart's struggle to pump blood effectively, leading to a range of debilitating effects on the body. Timely intervention is essential to manage heart decompensation and prevent further complications. 

Voice digital biomarkers have the potential to significantly enhance clinical trials for both COPD exacerbations and heart decompensation in HF. By analyzing vocal patterns through digital devices, these biomarkers can detect early signs of disease exacerbation, such as changes in breathing patterns, cough, or vocal tone, which are often difficult for patients to notice themselves. In COPD, this could help identify exacerbations before they lead to severe episodes, enabling earlier intervention. Similarly, in heart failure, voice biomarkers can track subtle changes linked to fluid retention or respiratory distress, offering valuable data for monitoring heart decompensation. Integrating voice biomarkers into clinical trials provides real-time, non-invasive insights, improving patient outcomes and enhancing the accuracy of trial results. 

​

Overall Goal:

Collaboratively work to advance the use of existing voice biomarkers in clinical trials for COPD and HF. By leveraging an established digital biomarker solution, we aim to explore the potential of these voice biomarkers as secondary or exploratory endpoints in clinical trials, enhancing measurement accuracy and patient monitoring. 

​

Specific Objectives:

1. Integrate the voice biomarkers as secondary or exploratory endpoints in ongoing or upcoming clinical trials. 

1. Identify and collaborate with pharmaceutical companies to participate in planned, ready-to-launch clinical studies for both COPD and HF. 

1. Develop an ecosystem around these digital biomarkers, working towards defining the measurements and achieving regulatory acceptance of these definitions. 
    

Potential Benefits:

• Competitive Advantage & Innovation Leadership: Early adoption of voice biomarkers positions pharma companies as pioneers in clinical innovation. Integrating novel, non-invasive monitoring tools enhances differentiation and strengthens the company’s reputation in digital health. 

• Enhanced Trial Efficiency & Data Quality: Voice biomarkers enable continuous, remote symptom monitoring, allowing for early detection of symptoms and more accurate endpoint data. This improves trial consistency and reduces reliance on subjective reporting. 

• Improved Patient Engagement & Retention: The simplicity and non-invasiveness of voice tools lower patient burden and improve adherence. They also support remote participation, expanding access and improving recruitment and retention rates. 

• Acceleration of Drug Development: Real-time data helps detect treatment effects earlier, enabling faster assessments of drug efficacy. This also supports more agile, adaptive trial designs that can respond dynamically to patient needs. 

• Regulatory & Market Readiness: Early involvement allows companies to shape digital biomarker validation and influence regulatory acceptance. Participation also demonstrates alignment with global priorities around digital health innovation. 

• Strategic Partnerships & Ecosystem Building: Collaborating with digital biomarker experts and stakeholders fosters knowledge sharing and faster implementation. It also offers insight into evolving standards and regulatory frameworks. 

• Long-Term Value Creation: Voice data collected during trials can serve as a rich resource for real-world evidence and post-market studies. Success in COPD and HF could extend the platform to other chronic conditions. 
   

Call for Collaboration:
DEEP is partnering with Zana, a leader in voice biomarker technology, to advance the use of voice and AI in healthcare. Zana has developed vocal digital biomarkers specifically designed for the early prediction of COPD exacerbations and heart decompensation in HF, supporting proactive and data-driven care.  

This initiative invites pharmaceutical companies focused on respiratory and cardiovascular diseases, particularly COPD and HF, to collaborate in advancing vocal digital biomarkers for use in clinical trials. Companies can participate by integrating Zana's technology into ongoing or upcoming clinical trials, using these digital biomarkers as secondary or exploratory endpoints. Additionally, pharma companies are encouraged to join and fund already planned clinical studies; one for COPD - and another for HF, supported by collaborations with digital health companies and university hospitals, offering access to patients with these conditions. 

​

Ways of contributing to a DEEP collaboration mission:

There are many ways that you can contribute to a DEEP collaboration mission. Contributions can be in the form of funding, time & expertise or prior work you have completed and would like to contribute to the cause in exchange for others contributions. DEEP's built in legal framework and mission contracting services aim to simplify the process of collaboration for all partners who would like to engage.

If you have questions, or if your organization is interested in contributing, please reach out to us here: