OVERVIEW
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.
For which indications is cough typically assessed?
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
SOLUTION FOR
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
1st
510(k)-cleared wearable device for lung sounds
24h
continuous recording
97%
accuracy in cough count**
100%
patients found the device easy to use***
**Strados Labs’ Cough Detection Algorithm Publication
***Sponsor Initiated Study, 2021
OVERVIEW VIDEO
Learn more about the benefits of Strados Labs’ RESP Biosensor System in clinical trials
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