R44HL147667

Respiratory Oxygen Adherence Monitor for COPD Patients - Project Summary/Abstract

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) affects over 15 million 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.

Barron Associates

THE DIVISION OF LUNG DISEASES SUPPORTS RESEARCH AND RESEARCH TRAINING ON THE CAUSES, DIAGNOSIS, PREVENTION, AND TREATMENT OF LUNG DISEASES AND SLEEP DISORDERS. RESEARCH IS FUNDED THROUGH INVESTIGATOR-INITIATED AND INSTITUTE-INITIATED GRANT PROGRAMS AND THROUGH CONTRACT PROGRAMS IN AREAS INCLUDING ASTHMA, BRONCHOPULMONARY DYSPLASIA, CHRONIC OBSTRUCTIVE PULMONARY DISEASE, CYSTIC FIBROSIS, RESPIRATORY NEUROBIOLOGY, SLEEP AND CIRCADIAN BIOLOGY, SLEEP-DISORDERED BREATHING, CRITICAL CARE AND ACUTE LUNG INJURY, DEVELOPMENTAL BIOLOGY AND PEDIATRIC PULMONARY DISEASES, IMMUNOLOGIC AND FIBROTIC PULMONARY DISEASE, RARE LUNG DISORDERS, PULMONARY VASCULAR DISEASE, AND PULMONARY COMPLICATIONS OF AIDS AND TUBERCULOSIS. THE DIVISION IS RESPONSIBLE FOR MONITORING THE LATEST RESEARCH DEVELOPMENTS IN THE EXTRAMURAL SCIENTIFIC COMMUNITY AS WELL AS IDENTIFYING RESEARCH GAPS AND NEEDS, OBTAINING ADVICE FROM EXPERTS IN THE FIELD, AND IMPLEMENTING PROGRAMS TO ADDRESS NEW OPPORTUNITIES. SMALL BUSINESS INNOVATION RESEARCH (SBIR) PROGRAM: TO STIMULATE TECHNOLOGICAL INNOVATION, USE SMALL BUSINESS TO MEET FEDERAL RESEARCH AND DEVELOPMENT NEEDS, FOSTER AND ENCOURAGE PARTICIPATION IN INNOVATION AND ENTREPRENEURSHIP BY SOCIALLY AND ECONOMICALLY DISADVANTAGED PERSONS, AND INCREASE PRIVATE-SECTOR COMMERCIALIZATION OF INNOVATIONS DERIVED FROM FEDERAL RESEARCH AND DEVELOPMENT FUNDING. SMALL BUSINESS TECHNOLOGY TRANSFER (STTR) PROGRAM: TO STIMULATE TECHNOLOGICAL INNOVATION, FOSTER TECHNOLOGY TRANSFER THROUGH COOPERATIVE R&D BETWEEN SMALL BUSINESSES AND RESEARCH INSTITUTIONS, AND INCREASE PRIVATE SECTOR COMMERCIALIZATION OF INNOVATIONS DERIVED FROM FEDERAL R&D.

93.837 - Cardiovascular Diseases Research

National Heart Lung and Blood Institute (NHLBI) [HHS - NIH]

Virginia United States

State-Wide

PHS 2022-2 Omnibus Solicitation of the NIH and CDC for Small Business Innovation Research Grant Applications (Parent SBIR [R43/R44] Clinical Trial Required) (PA-22-177)

Amendment Since initial award the End Date has been extended from 07/31/25 to 07/31/26 and the total obligations have increased 97% from $939,577 to $1,853,684.