# An unobtrusive monitoring device used for tracking asthma symptoms and lungfunction variability

> **NIH NIH R41** · CLAIRWAYS, LLC · 2020 · $55,000

## Abstract

Executive Summary of Predicate (One Page)
Summary of Specific Aims of Phase I
Specific Aim 1: Train and evaluate an algorithm to detect pediatric asthma symptoms (cough and
wheeze) on a low power, small form factor wearable device. Specifications: 90% sensitivity; false alarm
rate: 1 cough episode/day or 1 wheeze episode/day. Evaluate algorithm against medical expert
(physician) scoring using the two best available asthma scoring tools (AS: asthma score; PRAM: Pediatric
Respiratory Assessment Measure).
Specific Aim 2: Design and evaluate algorithm to detect lung function variability on a low power, small
form factor wearable device. Specifications: Using respiratory signals from sensor patch, detect
variations ≥ 10% in forced expiratory volume in 1 second to forced vital capacity (FEV1/FVC). Evaluate
algorithm against spirometry gold standard.
Progress towards Specific Aims
As of today, January 21, 2020, the work on the predicate NIH STTR award has not yet begun. The work
related to this NIH STTR is anticipated to begin April 2020. Prior to submitting our NIH STTR application,
significant work was completed to test the viability of collecting lung function using our wearable
technology. We tested on over 20 patients in the hospital, and in this study we found a positive
correlation between our measurements and those of spirometry. Our NIH STTR work will build upon
this.
Technical, administrative, or commercial challenges and how they’ve been addressed
During our customer discovery so far, we have learned about the complexities of achieving
reimbursement, even if we have identified applicable CPT codes. Realizing this challenge, we selected an
initial customer that will not require reimbursement. Our initial customer will be respiratory clinical
trials. From our interviews, we have learned that they have a strong unmet need, they are willing to pay
a large amount, and we will be able to serve them earlier than other customer types. We hope to
explore this further during this NIH I-Corps program.
Brief intro to team members
Principal Investigator: Justice Amoh, PhD, CTO of Clairways - Justice is a pioneer in embedded systems
for stochastic modelling of physiological signals. His focus is on deep neural network models for
detecting the onset of symptoms in respiratory diseases.
C-Level Corporate Officer: Jeff Bemowski, MBA, CEO of Clairways - Jeff is experienced in product
management, market research, and customer discovery for novel biomedical devices. He previously
worked in product management for Endotronix, a Series C funded medical device company.
Industry Expert: Bob Gatewood, VP Digital Health at Portal Instruments - Bob Gatewood is an
experienced healthcare and digital health entrepreneur. Bob was one of the founding members of
Athenahealth, which is now valued at over $5.5 billion. He has already worked through many of the
challenges Clairways will have to overcome, so his perspective will be very valuable to our team.
Additionally, Bob is ...

## Key facts

- **NIH application ID:** 10087375
- **Project number:** 3R41HL146027-01A1S1
- **Recipient organization:** CLAIRWAYS, LLC
- **Principal Investigator:** Justice Amoh
- **Activity code:** R41 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2020
- **Award amount:** $55,000
- **Award type:** 3
- **Project period:** 2020-09-18 → 2021-08-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10087375

## Citation

> US National Institutes of Health, RePORTER application 10087375, An unobtrusive monitoring device used for tracking asthma symptoms and lungfunction variability (3R41HL146027-01A1S1). Retrieved via AI Analytics 2026-05-23 from https://api.ai-analytics.org/grant/nih/10087375. Licensed CC0.

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