The problems in sleep medicine caused by the cost, access and variety of sleep laboratory testing have led to increasing use and demand for home testing particularly for evaluation of suspected sleep apnea. The definition of sleep-related breathing disorders (SRBD) has, however, expanded to include flow-limited breathing events. Assessment of these events and of hypopneas requires quantitative analyses of nasal airflow not provided by thermal sensors. Nasal air pressure, however, provides a quantitative measurement of airflow sufficiently accurate to detect both hypopneas and flow-limited breaths. In this project an untethered, miniature, sell-applied ambulatory unit (AirTrac) will be built to measure airflow from nasal pressure and record data for PC download. The AirTrac will detect apneas, hypopneas and flow-limited breaths and provide basic event rates and visual data display on the PC. The system will be compared to a full polysomnogram. In phase II automatic data analyses programs will be integrated into the monitor and the system tested in clinical trials. This device could facilitate clinical screening and treatment evaluations for SRBD as part of the continuum of care in sleep medicine and could also expand opportunities for clinical research.

Proposed Commercial Applications

The prevalence of the obstructive sleep apnea/hypopnea syndrome (OSAHS) is estimated at about 4 - 5% of the population. The high consequences of this disease and the cost of polysomnography make simplified recording techniques for screening and diagnosing imperative. Air pressure has become recommended as a primary measure for evaluation of OSAHS. The AirTrac if established as a physicians, home-testing agencies and similar clinical environments.

Agency
National Institute of Health (NIH)
Institute
National Heart, Lung, and Blood Institute (NHLBI)
Type
Small Business Innovation Research Grants (SBIR) - Phase I (R43)
Project #
1R43HL065166-01A1
Application #
6294084
Study Section
Special Emphasis Panel (ZRG1-BDCN-6 (02))
Program Officer
Rothgeb, Ann E
Project Start
2001-05-01
Project End
2002-09-30
Budget Start
2001-05-01
Budget End
2002-09-30
Support Year
1
Fiscal Year
2001
Total Cost
$120,665
Indirect Cost
Name
Im Systems
Department
Type
DUNS #
City
Baltimore
State
MD
Country
United States
Zip Code
21286