1. Introduction
Cough, a common symptom of various respiratory illnesses, is often underestimated in clinical assessment despite its profound impact on patient health and quality of life. Whether due to chronic conditions like asthma, chronic obstructive pulmonary disease (COPD), or acute infections, accurate monitoring of cough frequency and severity is crucial for effective diagnosis, treatment, and disease management.[1] Traditionally, cough monitoring has been subjective, relying on patient self-reporting, which can be inaccurate or incomplete. The widespread use of cough counting tools has, to date, been limited by a reliance on human input to determine cough frequency. However, advancements in digital technology and audio recording over the past twenty years have significantly diminished this reliance. Consequently, cough frequency is now widely acknowledged as a quantifiable indicator of respiratory conditions. It has become the benchmark primary endpoint in clinical trials for new chronic cough treatments.[1] Cough monitoring devices are essential tools for managing respiratory diseases, providing objective frequency based data that enhances clinical assessments.
Recent advancements in digital and wearable technology have ushered in a new era of automated cough monitoring systems that provide objective, real-time data, improving both patient care and research capabilities. This article delves into various approved cough monitoring technologies, their benefits, ease of use, and emerging technologies that promise to further transform respiratory care.
2. The Need for Real-Time Cough Monitoring
Cough monitoring has historically been performed through self-reporting or manual counting in clinical environments, both of which are prone to errors. For chronic respiratory conditions like COPD, chronic cough, asthma, or post-viral syndromes, the ability to monitor cough in real-time is critical for adjusting treatments and managing exacerbations. Real-time monitoring enables clinicians to identify patterns of coughing, assess the effectiveness of medications, and anticipate flare-ups in conditions such as asthma and COPD.[2] Additionally, in infectious diseases like tuberculosis[3] or COVID-19,[4] continuous cough monitoring provides data that can help in early detection and spread management.
Moreover, cough is not just a clinical concern but also affects the quality of life, including social interactions and sleep. For these reasons, real-time monitoring technologies hold great potential in improving disease management, patient comfort, and even public health outcomes.
3. Benefits of Digital Cough Monitoring
- Objective data: Digital monitoring provides quantifiable, unbiased data that can replace patient-reported measures, which are often inconsistent or inaccurate.
- Early detection: Devices capable of real-time monitoring can detect subtle changes in cough patterns, alerting physicians to exacerbations before they become severe.
- Improved disease management: For chronic conditions, continuous monitoring helps in adjusting medications in real-time, improving outcomes.
- Research applications: Objective data generated by digital monitoring devices are invaluable in clinical trials, enabling more accurate measurement of drug efficacy.
- Patient comfort: Wearable and non-invasive technologies allow patients to be monitored without disrupting their daily lives.
- Ease of use and physician benefits: From a user perspective, many modern cough monitoring devices are designed to be worn comfortably and integrate seamlessly into daily life. For healthcare providers, these devices offer a wealth of real-time, continuous data, enabling more precise diagnosis and treatment planning.[5] Physicians benefit from automatic reports generated by these systems, allowing them to track patients’ symptoms remotely and intervene earlier if needed.
4. Types of Cough Monitoring Devices
- Ambulatory cough meters: Utilizing repurposed Holter monitors, these devices objectively track cough frequency over 24 hours, demonstrating good agreement with traditional recording methods.[6]
- Acoustic detection algorithms: Algorithms that analyze acoustic signals can automatically detect cough events with high sensitivity (90%+) and specificity (98%+), making them suitable for remote monitoring.[7]
- Mobile platforms: Several mobile platforms are available for cough monitoring, which leverage smartphone sensors and AI-based algorithms to track and analyze coughs. These platforms provide convenient, user-friendly solutions for remote and continuous monitoring without the need for additional hardware.[1]
5. Approved Cough Monitoring Devices
Some of the key, approved cough monitoring devices currently available include:
5.1 VitaloJAK[8]
The VitaloJAK is a unique development from Vitalograph in partnership with internationally renowned cough researchers working at Manchester University NHS Foundation Trust, UK. The VitaloJAK® cough monitor provides the only fully validated system for objective measurement of cough. Ambulatory cough recordings of up to 24 hours undergo centralized, semi-automated analysis to provide quantified data. The VitaloJAK algorithm removes non-cough data from cough recordings, reducing the file size to allow efficient analysis by our team of trained cough analysts. Data generated by the system has proven to have median sensitivity >99% and excellent integrity. The system has been used for research since 2005 and in Phase 2 and 3 studies globally since 2014. This is a validated, 510k cleared and CE marked medical device system.[8]
5.2 Leicester cough monitor[9, 10]
The Leicester cough monitor (LCM) is an automated system for recording and analyzing coughs, particularly useful for chronic cough studies. It captures sound-based data via mp3 digital recorder over a 24-hour period and has been validated in clinical research for its reliability and utility in cough frequency monitoring. It is a non-invasive, ambulatory device that has been validated for both adult and pediatric use in clinical trials and research settings. LCM offers a simple yet reliable method for quantifying cough frequency, making it a powerful tool for both diagnosing cough-related disorders and monitoring the effectiveness of treatment interventions.
5.3 PulmoTrack®-CC[11]
The PulmoTrack-CC is designed specifically for continuous cough monitoring in both clinical and home environments. PulmoTrack® enables the continuous monitoring of wheezes, even in cases without patient cooperation. Using sensors placed on the patient’s chest, the device captures cough events, providing both audio and visual data on the cough characteristics. It also has an integrated machine-learning algorithm that helps distinguish coughs from other noises, improving the accuracy of its recordings. PulmoTrack is FDA-approved and widely used in respiratory clinical trials, particularly in COPD and asthma research.
5.4 Hyfe Cough Tracker[12]
Hyfe Cough Tracker stands out because it is an FDA-approved smartphone application that uses machine learning to analyze and track coughs. Hyfe’s cough monitor suite offers continuous, clinically validated monitoring with always-on performance in real-world settings. It combines a wearable device, an easy-to-use companion app, and a comprehensive dashboard for seamless tracking and analysis. Hyfe records and identifies coughs throughout the day, providing continuous monitoring without the need for additional hardware. Its smartphone app is particularly beneficial for telemedicine, as it allows physicians to remotely monitor cough frequency and severity in patients with chronic respiratory conditions or infectious diseases.
5.5 LifeShirt[13]
The LifeShirt system by VivoMetrics is a wearable vest integrated with sensors that continuously monitor respiratory activity, including cough frequency and intensity. FDA-approved for clinical use, LifeShirt has found application in a wide range of respiratory disorders, from asthma to cystic fibrosis. The device records detailed physiological data, which is then analyzed to provide clinicians with insights into respiratory patterns, sleep disorders, and the overall health status of patients.
5.6 RESP® Biosensor by Strados Labs[14]
This platform received FDA clearance for home use in May 2022. It uses smart sensors to detect respiratory sounds, including coughs, and is suitable for remote patient monitoring. The RESP® Biosensor provides real-time, objective monitoring of respiratory symptoms, bridging care from hospital to home. Designed for patients with conditions like COPD and asthma, it tracks early signs of exacerbations such as coughing and wheezing, helping clinicians better assess respiratory health remotely. This FDA 510(k) Class II device is CE-marked, HIPAA-compliant, and captures lung sounds continuously without disrupting patients’ daily lives. Its small, unobtrusive design ensures comfort and ease, boosting compliance while delivering comprehensive data to healthcare teams. Features include monitoring of cough, wheeze, rhonchi, and crackles—allowing timely intervention for flare-ups and improved patient outcomes.
5.7 SIVA Health Cough Monitoring System[15]
SIVA System is a novel patient-centric and fully automated 24/7 cough detection solution, which provides longitudinal real-life cough profiles and contextual data to healthcare professionals, pharmaceutical study sponsors and researchers. It has received certification according to the European Medical Device Regulation (MDR). It is an AI-powered system for continuous, automated cough monitoring. Designed to function in real-world environments, SIVA’s technology captures cough data in real-time, providing healthcare professionals with valuable insights for managing chronic respiratory conditions like COPD and asthma. The SIVA Wearable cough monitor is a small device with various sensors (sound, vibrations), that is worn around the neck on a strap at chest level. The platform integrates seamlessly with existing medical infrastructures, enabling remote patient monitoring while ensuring user privacy and comfort. The system supports proactive healthcare management by identifying early signs of disease progression or exacerbation, potentially reducing hospitalizations and improving patient outcomes.
5.8 ANNE one[16]
The ANNE one wearable monitoring system by Sibel Health, which boasts multiple FDA clearances (K211305, K220095, and K223711) for monitoring respiratory disease symptoms. This advanced device features an enhanced predictive algorithm designed to detect COVID-19 and track cough counts, with plans to further develop a clinical-grade artificial intelligence (AI) algorithm for even more accurate cough detection.
6. Smartphone-Based Cough Monitoring Systems
In today’s digital age, smartphone-based cough monitoring systems are transforming the way we manage respiratory health. Harnessing the power of artificial intelligence and machine learning, innovative tools like NuvoAir, CoughPro, ResApp, TimBre™, and Talli Health Symptom Tracker are empowering individuals and healthcare providers alike by enabling real-time tracking, early diagnosis, and personalized care. Newer devices and pipeline technologies
6.1 Swaasa® AI[17]: Swaasa® is a real-time, affordable, and self-operated cloud-based telehealth system designed to non-invasively analyze cough sounds and symptoms related to respiratory conditions. Utilizing advanced AI and machine learning models, Swaasa® assesses cough sounds alongside vital information such as temperature, oxygen saturation, and additional symptoms to evaluate lung performance accurately. By leveraging telehealth technology, Swaasa® aims to revolutionize pulmonary healthcare, offering an accessible and cost-effective alternative to traditional spirometry, enabling individuals to monitor their respiratory health from the comfort of their homes.
6.2 WellFie[18]: It is an augmented intelligence app that enables contactless health tracking using smartphones to check key health vitals in just seconds. By analyzing a real-time video of a person’s face, WellFie accurately assesses a wide range of physiological parameters. Designed to monitor chronic illnesses with real-time data, WellFie reduces strain for patients with limited mobility while providing efficient and highly accurate vital checks, including heart rate, breathing, stress levels, oxygen saturation, and blood pressure.
6.3 NuvoAir[19]: NuvoAir offers a comprehensive digital care management platform that empowers individuals with respiratory conditions to monitor their health from home and share real-time results with their healthcare providers and care coordinators. The platform features a patient app that integrates connected devices, self-management resources, care coordination services, and a healthcare provider portal. It utilizes an AI-driven algorithm to identify coughs or bursts of coughing and relays that information to the user’s care team.
6.4 Cough Pro[20]: Cough Pro uses machine learning algorithms to detect when a sound is a cough. Audio signals from smartphones are transformed into a visual representation that shows the frequency of the signal as it changes over time. This real-time monitoring allows users to track their coughing patterns, enhancing their understanding of respiratory health.
6.5 ResApp[21]: ResApp’s standalone cough counter application monitors cough frequency using just a smartphone. It employs proprietary machine learning algorithms to accurately detect cough events from audio recorded by the smartphone’s built-in microphone. Developed by ResApp Health Limited (ASX), a leading digital health company, the app has received clearance from the Australian Therapeutics Administration (TGA) and CE Mark certification, making it the world’s first regulatory-approved standalone cough counter smartphone application.
6.6 TimBreTM[22]: TimBre™ is a non-invasive tuberculosis screening tool that detects TB infection without invasive procedures, potentially improving TB diagnosis and patient outcomes. Utilizing advanced machine learning algorithms to analyze cough sounds recorded on smartphones, it enables non-invasive monitoring and rapid detection of TB. TimBre™ has the potential to significantly impact global public health efforts against TB.
6.7 Talli Health Symptom Tracker[23]: It is a digital tool designed to help users monitor and manage their health symptoms effectively. With its user-friendly interface, the app allows individuals to log various health indicators and customize tracking based on their specific conditions. It features clear data visualizations to highlight trends, facilitating better communication with healthcare providers. Particularly beneficial for those managing chronic illnesses, Talli Health empowers users to take control of their health and improve overall wellbeing.
- Other wearable sensor-based devices, such as the soft skin-interfaced mechano-acoustic sensors[24], Resmetrix[25], Spire Health Tag[26], and the Mintti Smartho-D2 digital stethoscope[27], C-MO System[28], NIOX MINO[29] etc. are under pipeline and provide further enhancements to real-time and patient centric digital monitoring of respiratory conditions.
7. Conclusion
The development of digital cough monitoring technologies has opened new pathways for enhancing patient care, research, and clinical trials. These systems provide real-time, objective data that is invaluable for managing chronic respiratory diseases and improving patient outcomes. Wearable devices, smartphone applications, and acoustic sensors are making continuous monitoring more accessible to both patients and healthcare providers. As these technologies continue to advance, particularly with the integration of AI and machine learning, we can expect even more personalized and effective respiratory care in the future. The shift towards digital health tools like these also aligns with the broader trends in telemedicine and remote patient monitoring, paving the way for more efficient and proactive healthcare delivery.
8. References
1. Sterling M, Rhee H, Bocko M. Automated cough assessment on a mobile platform. Journal of medical engineering. 2014;2014(1):951621.
2. Hall JI, Lozano M, Estrada-Petrocelli L, Birring S, Turner R. The present and future of cough counting tools. Journal of thoracic disease. 2020;12(9):5207.
3. Huddart S, Asege L, Jaganath D, Golla M, Dang H, Lovelina L, et al. Continuous cough monitoring: a novel digital biomarker for TB diagnosis and treatment response monitoring. The International Journal of Tuberculosis and Lung Disease. 2023;27(3):221-2.
4. Laguarta J, Hueto F, Subirana B. COVID-19 artificial intelligence diagnosis using only cough recordings. IEEE Open Journal of Engineering in Medicine and Biology. 2020;1:275-81.
5. Smokovski I, Steinle N, Behnke A, Bhaskar SM, Grech G, Richter K, et al. Digital biomarkers: 3PM approach revolutionizing chronic disease management—EPMA 2024 position. EPMA Journal. 2024:1-14.
6. Chang A, Newman R, Phelan P, Robertson C. A new use for an old Holter monitor: an ambulatory cough meter. European Respiratory Journal. 1997;10(7):1637-9.
7. Pramono RXA, Imtiaz SA, Rodriguez-Villegas E, editors. Automatic cough detection in acoustic signal using spectral features. 2019 41st Annual International Conference of the IEEE Engineering in Medicine and Biology Society (EMBC); 2019: IEEE.
8. Vitalograph. VitaloJAK 2024 [Available from: https://vitalograph.com/products/vitalojak.
9. Hall JI, Lozano M, Estrada-Petrocelli L, Birring S, Turner R. The present and future of cough counting tools. J Thorac Dis. 2020;12(9):5207-23.
10. Birring S, Fleming T, Matos S, Raj A, Evans D, Pavord I. The Leicester Cough Monitor: preliminary validation of an automated cough detection system in chronic cough. European Respiratory Journal. 2008;31(5):1013-8.
11. iSonea. Pulmotrack® – Respiratory Acoustic Monitor 2024 [Available from: https://www.isoneamed.com/solution-pulmotrack.html.
12. Hyfe. Hyfe’s CoughMonitor Suite: Continuous, clinically validated cough monitoring 2024 [Available from: https://www.hyfe.com/.
13. Cárdenas AF, Pon RK, Cameron RB, editors. Management of Streaming Body Sensor Data for Medical Information Systems. METMBS; 2003.
14. Labs S. RESP® Biosensor: Strados 2024 [Available from: https://stradoslabs.com/resp-biosensor-healthcare/.
15. health S. SIVA-P3 Wearable 2024 [Available from: https://www.siva-health.com/.
16. Walter JR, Lee JY, Yu L, Kim B, Martell K, Opdycke A, et al. Use of artificial intelligence to develop predictive algorithms of cough and PCR-confirmed COVID-19 infections based on inputs from clinical-grade wearable sensors. Scientific Reports. 2024;14(1):8072.
17. AI S. Swaasa for respiratory healthcare 2024 [Available from: https://swaasa.ai/.
18. WEllFie. AI Based Wellness Selfie 2024 [Available from: https://wellfie.in/.
19. medical N. NuvoAir 2024 [Available from: https://nuvoair.com/.
20. Pro C. Cough Pro 2024 [Available from: https://coughpro.com/.
21. news U. ResApp-UQ startup acquired by Pfizer. UQ news. 2024.
22. Docturnal. TimBre™ non invasive acoustic screening for TB 2024 [Available from: https://docturnal.com/timbre/.
23. Tracker THS. Talli Health Symptom Tracker App 2024 [Available from: https://talli.me/apps/symptom-tracker.
24. Kang YJ, Arafa HM, Yoo J-Y, Kantarcigil C, Kim J-T, Jeong H, et al. Soft skin-interfaced mechano-acoustic sensors for real-time monitoring and patient feedback on respiratory and swallowing biomechanics. npj Digital Medicine. 2022;5(1):147.
25. Vitazkova D, Foltan E, Kosnacova H, Micjan M, Donoval M, Kuzma A, et al. Advances in Respiratory Monitoring: A Comprehensive Review of Wearable and Remote Technologies. Biosensors (Basel). 2024;14(2).
26. Spire Health Tag 2024 [Available from: https://www.spirehealth.com/.
27. Minttihealth Digital Stethoscope Mintti Smartho-D2 2024 [Available from: https://minttihealth.com/product/digital-stethoscope-mintti-smartho-d2/.
28. solutions C-m. C-MO System 2024 [Available from: https://c-mo.solutions/.
29. NIOX. FeNO by NIOX® 2024 [Available from: https://www.niox.com/en/.
