SBIR-STTR Award

Miniature Ambulatory Hot Flash Monitor
Award last edited on: 11/9/05

Sponsored Program
SBIR
Awarding Agency
NIH : NIAT
Total Award Amount
$999,989
Award Phase
2
Solicitation Topic Code
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Principal Investigator
John G Webster

Company Information

Bahr Management Inc

6632 North Chickahauk Trail
Middleton, WI 53562
   (608) 831-2310
   bahr@inxpress.net
   www.bahr.com
Location: Single
Congr. District: 02
County: Dane

Phase I

Contract Number: 1R43AT003183-01
Start Date: 00/00/00    Completed: 00/00/00
Phase I year
2005
Phase I Amount
$250,000
The characteristics of existing sternal skin conductance monitors that hinder use under ambulatory conditions and for long tern data collection are that they are too bulky to be cosmetically acceptable, have distracting wires, and weigh too much. We propose to characterize hot flashes by measuring the frequency, timing, and the amplitude of hot flashes using sternal skin conductance. Our chosen approach is to develop a miniature ambulatory recorder that is precise, functional, and aesthetically appropriate. We have assembled a team with expertise in required fields to implement the application goals. Team members include a clinical collaborator to supervise testing on a sample of menopausal women, a biomedical engineer experienced in electrode testing, a small business biomedical engineer experienced in the design and development of miniature medical instruments, and a biomedical engineer experienced in both miniaturization and conductive adhesive polymer testing. Our team will develop and test an unobtrusive (no wires) miniature instrument to objectively measure and record hot flashes. Our specific aims are: 1-Meet with a menopausal women's focus group to gain information on preferred approaches. 2-Develop electrode and electrolyte compositions that stabilize skin conductivity. 3-Design an electronic and electrode package and test the prototype in the laboratory. 4-Design and implement hot flash pattern recognition software. 5-Manufacture 6 instruments and test on a small supervised group of women with documented hot flash occurrences. 6-Redesign as necessary, manufacture 30 instruments and test on a large unsupervised group of menopausal women representing a spectrum of hot flash occurrence (20 women with at least 5 daily and nightly hot flashes, 5 women with less severe hot flashes(< 5 daily) and 5 women who do not experience hot flashes. 7-lnvestigate the data quality under ambulatory conditions of typical daily living 8-Compare the objective data (proposed monitor) with subjective data (subject recorded hot flashes)

Phase II

Contract Number: 2R44AT003183-02
Start Date: 00/00/00    Completed: 00/00/00
Phase II year
2008
Phase II Amount
$749,989
We were originally awarded SBIR grant R43AT003183-01 in September 2005 to develop a miniature, wireless skin conductance monitor to measure hot flash frequency and severity. A prototype monitor was developed that measures changes in sternal skin conductance and uses pattern recognition software to recognize the frequency, and timing of hot flashes. The electrodes consisted of a 7 W 4 cm disposable adhesive patch containing two conductive adhesive polymer electrodes containing a low concentration of sodium chloride. We named the project FLAMES (FLAsh Monitor Evaluation Studies) Development and testing proceeded in phases. The Phase I prototype monitor was a unit the size of a deck of cards, worn on a belt and was connected to the electrodes by 70 cm long wires. Subsequently, the circuitry was miniaturized and we developed a small, nondisposable, coated circuit board that snaps onto the electrodes and operates up to a month on a small battery. The monitor is 7 cm long W 2 cm wide W 6 mm thick and weighs less than 15 g. This version of the monitor was used for the remaining phases of clinical testing. Data regarding the frequency, timing, and amplitude of hot flashes are downloaded directly from the monitor to data acquisition software. Researchers at the UCSF Women's Health Clinical Research Center collaborated with the biomedical engineers at Bahr Management, Inc. to develop and test the monitor in women with hot flashes. We now aim to produce a version of the monitor that is adequate for commercialization. We will improve the monitor by making the battery rechargeable, increasing water-resistance, providing real-time display in the laboratory, recording for one month, and increasing speed of software download and display. We will test reproducibility and accuracy in 50 peri- or postmenopausal women with hot flashes and subsequently in a multi-center intervention trial in women with hot flashes.

Public Health Relevance:
Hot flashes are common in peri- and postmenopausal women and negatively impact quality of life. The frequency and severity of hot flashes are generally measured by self-report, which may not be complete, especially during sleep. We designed and tested the accuracy of a miniature hot flash monitor that measures changes in skin conductance to automatically detect hot flash frequency in ambulatory women over a 7-day period.

Public Health Relevance:
This Public Health Relevance is not available.

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