Cough monitoring

Cough monitoring has been moving away from subjective patient self-reporting in favor of more objective and quantitative measures. As regulators continue to look for more granular cough and lung sound metrics, we continue to partner with device manufacturers to bring sponsors the most advanced respiratory trial solutions to meet these needs.

Cough and lung sounds are evaluated for a number of respiratory diseases:

  • Asthma
  • Chronic Obstructive Pulmonary Disease (COPD)
  • Chronic bronchitis
  • Cardiopulmonary diseases
  • Allergies
  • Gastroesophageal Reflux Disease (GERD)
  • Sleep disorders and nocturnal wheezing
  • Postnasal drip

Objective cough and lung sound monitoring

Clario supports accurate, in-home monitoring of cough and lung sounds through Strados Labs’ RESP ™ Biosensor, a lightweight, wearable device able to capture 24 hours of continuous cough recordings. Used in combination with the Clario iSpiro® home spirometry solution, the RESP Biosensor enables sponsors to gain objective cough metrics alongside spirometry and eCOA data.

Strados Labs’ RESP ™ Biosensor System

Allows for the following endpoints:*
  • Cough count, severity and spasms
  • Lung sounds: wheezing, crackles, rhonchi, snore and others
  • Respiratory rate
  • Chest wall motion (chest excursion) as measured by on-board accelerometer
Benefits of the Clario and Strados Labs Solution:
  • iSpiro, RESP and eCOA applications all on the same handheld device
  • Continuous recording of up to 24 hours on a single charge
  • Small, comfortable, hands-free device with no wires
  • Clinically validated, FDA-cleared 510(k) device
  • Advanced algorithms to identify pulmonary events*
  • HIPAA-compliant, encrypted data storage and transfer

Patient-friendly wireless device

Advanced machine learning algorithm identifies various respiratory events with high accuracy*

Granular data over a 24-hour period with concurrent measurement of various respiratory endpoints

*Algorithms, respiratory rate and chest excursions not yet FDA cleared

RESP Biosensor metrics at-a-glance

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510(k)-cleared wearable device for lung sounds

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continuous recording

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accuracy in cough count**

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patients found the device easy to use***

**Strados Labs’ Cough Detection Algorithm Publication
***Sponsor Initiated Study, 2021


Learn more about the benefits of Strados Labs’ RESP Biosensor System in clinical trials

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