Cough as an Endpoint in IPF: Why it Matters

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RESEARCH & CLINICAL TRIALS

RESP® Biosensor

Continuous lung sound and cough monitoring for greater insights in research studies and drug development

FDA 510(k) Class II Device | CE Mark | HIPAA Compliant

cough monitoring RESP biosensor

Cough and wheeze are highly prevalent, burdensome symptoms across many respiratory and infectious diseases. Patient-reported outcomes (PROs), while valuable, may not fully capture the reality these symptoms present. The RESP® Biosensor measures the full scope of respiratory symptoms, providing greater insight in clinical trials and research alongside PROs and pulmonary function tests.

Technology Overview

The RESP® Biosensor allows researchers and drug developers to objectively measure patients’ cough and lung sounds in Phase I – IV clinical trials. Optimized for ease of use at home, our cough monitoring device offers:

  • Patient-Friendly Form Factor: A wireless, discreet design that respects patient comfort and lifestyle.
  • Rapid, Reliable Data Access: Direct cloud sync facilitates efficient analysis of objective respiratory metrics.
  • Comprehensive Data: Respiratory measurements provide greater insights into treatment response and differentiation for clinical programs and candidates.
RESP Biosensor Cough Monitoring Device

RESP® Biosensor Measures

Configure

Cough Monitoring

24-Hour Cough Frequency, Intensity* and Bouts

Configure

Lung Sounds

Wheeze, Rhonchi, Crackles
Configure

Additional Insights*

Respiratory Rate, Heart Rate, Activity Levels, Sleep/Wake, and Body Positioning

*For investigational use only

Trusted By

Why Choose the RESP® Biosensor for Cough Monitoring?

Privacy & Security

Incorporates end-to-end encryption and advanced noise filtering for preserve patient privacy.

Accelerated Data Turnaround

Real-time, cloud-based syncs from paired mobile device streamline data reporting and overread process.

Subject Cough Only

Multi-modal data are used to differentiate between subject coughs and external coughs.

Patient-Friendly Form Factor

Low-burden, sleek design aids patient comfort and compliance while mirroring real-life conditions.

Comprehensive Insights

Extended measurements beyond cough frequency allow for a greater understanding of lung health and subject quality of life.

Metrics-at-a-Glance

700k+

Validated Coughs Captured

20m+

Breaths Captured

4
Continents
35
Languages
2
FDA 510(K) clearances
1
CE Mark

Clinical Evidence

The value and clinical validation of the RESP Biosensor has been presented at several respiratory conferences including the American Thoracic Society and CHEST.

RESP® Biosensor Therapeutic Areas

Using a combination of audio and motion data, the RESP Biosensor unlocks valuable insight across multiple indications, offering a more complete picture of subjects’ respiratory status and health-related quality of life alongside PROs.

Cough Wheeze Crackles Respiratory Rate* Activity Levels* Sleep/Wake* Body Positioning*
Chronic Cough
IPF
Bronchitis
COPD
Asthma
RSV
Covid-19
Heart Failure
  • Chronic Cough
  • IPF
  • Bronchitis
  • COPD
  • Asthma
  • RSV
  • Covid-19
  • Heart Failure

*For investigational use only

Cough Monitoring Device - RESP Biosensor

The Cough Monitoring Device Patients Prefer

  • Compared to bulkier alternatives, the RESP Biosensor reduces patient burden.
  • Wireless and discreet, patients report that they forget the cough monitoring device is on and that it doesn’t interfere with daily routines.
  • Sleek design helps ensure patients behave naturally, capturing authentic symptom data that mirrors real-life conditions and minimizes the Hawthorne effect.

Validated Overread and Event Annotation Process

Strados RESP biosensor data
  • Our cough counting approach includes a consensus labeling process to ensure the highest level of accuracy and to meet endpoint requirements.
  • Machine learning algorithms* for automated cough counting have also been performance-tested to meet customer requirements.
  • Algorithms* allow for compression of cough recordings for human annotation or can be used independently for subject screening and other applications.

**Machine learning algorithms not FDA-cleared

Visual spectrograms of lung sound events facilitate overread for trained specialists

Cough

Wheeze

Crackles

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Explore using the RESP® Biosensor in your next study