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Respiratory Oxygen Adherence Monitor for COPD Patients

Award Information
Agency: Department of Health and Human Services
Branch: National Institutes of Health
Contract: 2R44HL147667-02A1
Agency Tracking Number: R44HL147667
Amount: $939,577.00
Phase: Phase II
Program: SBIR
Solicitation Topic Code: NHLBI
Solicitation Number: PA22-177
Solicitation Year: 2022
Award Year: 2023
Award Start Date (Proposal Award Date): 2023-08-21
Award End Date (Contract End Date): 2025-07-31
Small Business Information
1410 Sachem Place
Charlottesville, VA 22901-2496
United States
DUNS: 120839477
HUBZone Owned: No
Woman Owned: No
Socially and Economically Disadvantaged: No
Principal Investigator
 (434) 973-1215
Business Contact
Phone: (434) 973-1215
Research Institution

Introduction: The Respiratory Oxygen Adherence Monitor (ROAM) system will provide an effective, practical,
and affordable method to reliably assess and improve long-term-oxygen therapy (LTOT) adherence.
Problem to be Addressed: Chronic obstructive pulmonary disease (COPD) over 15 people in the
United States; the condition causes more than 500,000 hospitalizations and over 100,000 deaths annually. LTOT,
which is generally administered to patients via a nasal cannula attached to an oxygen source, is the only
treatment that has been shown to improve survival in severe hypoxemia due to cardiopulmonary disease. The
improvement in mortality is greatest when oxygen therapy is used at least 16 hours/day. LTOT is also associated
with significant reductions in hospitalizations and lengths of stay, and improved quality of life. Despite the
benefits of LTOT, adherence remains a challenge for most patients. Furthermore, the ability to accurately assess
patient LTOT adherence is limited by current technology, all of which fail to discern whether the patient is
actually wearing the nasal cannula and inhaling oxygen, as opposed to merely having the oxygen source turned
on. Present measures also fail to provide information regarding the pattern of oxygen use for each 24-hour
interval. An objective and accurate method for measuring patient adherence to LTOT is required to increase
clinical effectiveness and improve outcomes.
Phase I Results: During the Phase I effort, a ROAM system prototype was developed and verified to be highly
accurate at determining when the user was wearing the nasal cannula and inhaling oxygen. The data recorded
include minute-by-minute classifications for adherence vs. non-adherence, which provide required and relevant
information regarding patterns of usage and overall adherence times.
Phase II Hypothesis: The SBIR Phase II program will test the hypothesis that adherence feedback provided to
patients by the ROAM system, which includes daily pulse oximetry measurements (a critical health status
metric), will result in increased adherence to LTOT.
Phase II Summary: In the proposed SBIR Phase II effort, the team will develop a commercial-ready ROAM
system using refined hardware components and the inclusion of a software interface that enables patients and
authorized healthcare providers to access adherence data, including pulse oximetry measures. The system will
provide patients with informational, attentional, and motivational feedback to encourage and improve
adherence. The proposed effort will also verify the accuracy and usability of the next-generation ROAM system,
and will culminate with a randomized, controlled field trial with COPD patients to demonstrate system efficacy.
Public Health Impact: The ROAM system will increase LTOT adherence, lead to improved outcomes for
patients with cardiopulmonary disease, and reduce the healthcare costs that are associated with expensive and
preventable hospitalizations due to non-adherence.

* Information listed above is at the time of submission. *

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