Cough Monitoring for Clinical Trials

Our team of expert Cough Analysts are available to provide objective cough counts recorded using the VitaloJAK® Cough Monitor to provide gold standard objective cough counts.

Our Experience

At Vitalograph, we have proven expertise in Cough Studies. With over 58 clinical trials with world-leading pharmaceutical and research partners, 22 million coughs counted, and 37,000 recorded sessions (As of October, 2024).

Vitalograph is an industry leader in cough frequency assessment. We provide objective cough counts recorded using the VitaloJAK® Cough Monitoring System. This system has redefined how cough is measured in clinical trials by providing evidence for therapeutic effect of investigational medicinal products in conditions such as chronic cough, IPF, asthma, COPD and cystic fibrosis.

Output data accuracy:

>99% sensitivity, >97% specificity and intra- and inter-rater reliability for 24-hour recordings shown to exceed 0.99

DOWNLOAD eBOOK: Objective Cough Monitoring in Clinical Trials

Our Support

Vitalograph’s team of expert Cough Analysts are available to provide objective cough counts recorded using the VitaloJAK® Cough Monitor. Recordings are uploaded by Sites through the central data management system, the Vitalograph Web Portal. They are then processed through the semi-automated cough analysis system using a compression algorithm developed by the internationally renowned cough researchers Prof Jacky Smith, Dr. Kevin McGuiness, and Prof Ashley Woodcock, working at Manchester University NHS Foundation Trust (MFT).

A detailed Cough Analysis plan will be agreed upon at the start of the Study to ensure the definition of cough, query resolution, handling of early terminations, level of QC and other requirements as clearly specified.

Clinical Trial Management Services Include:

Clinical trial devices and software including VitaloJAK high fidelity cough monitoring device and test kits, Vitalograph Web Portal to collect and manage analysis of cough data and VitaloJAK algorithm to remove non-cough sounds.
An expert cough analysis service: Benefit from continuous access to subject matter experts throughout the lifecycle of your study, ensuring informed decisions at every stage.
Professional and dedicated study services. Study reports can be tailored to your needs so that the primary, secondary and/or exploratory endpoints can be reviewed on a regular basis, giving you live overview of your study.

Key Endpoints We Measure

Objective frequency of cough is the preferred assessment of cough in clinical trials.

We offer a robust, customisable system for the measurement and analysis of cough study data in Phase I – IV trials. The study reports can be tailored to your needs so that the primary, secondary and/or exploratory endpoints can be reviewed on a regular basis, giving you live overview of your study.

Criteria	Example Endpoints
Cough counts	Cough count over the 24-hour recording Cough count per hourly segments Including screening, baseline and treatment counts. Change from baseline in awake cough frequency
Events	Sleep / wake events Quality events
Subjective Endpoints	Quality of life questionnaires Cough questionnaire

“Measures of both intra- and inter-rater reliability for both filtered and full-length 24-hour recordings were found to be excellent, exceeding a reliability of 0.99” 

Mines et al. Assessment of Inter- and Intra- Rater Reliability of Objective Cough Frequency in patients with Chronic Cough. European Respiratory Journal 2019; 54: Suppl. 63, PA4342

Case Study

Cough: Study solutions for a global trial

A customer was conducting a suite of phase II/III Clinical trials to investigate the efficacy and safety of an investigational medicinal product in patients with chronic cough. These were global studies with >300 sites, >3000 VitaloJAKs and 30,000 sensor kits and data cards.

Cough: Study solutions for a global trial