Self-Reported Menopausal Symptomatology and Wireless Skin Conductance Recorder

Award Information
Agency:
Department of Health and Human Services
Branch
n/a
Amount:
$243,792.00
Award Year:
2006
Program:
SBIR
Phase:
Phase I
Contract:
1R43AT004075-01
Award Id:
79731
Agency Tracking Number:
AT004075
Solicitation Year:
n/a
Solicitation Topic Code:
n/a
Solicitation Number:
n/a
Small Business Information
6901 EAST FISH LAKE ROAD, SUITE #190, MAPLE GROVE, MN, 55369
Hubzone Owned:
N
Minority Owned:
N
Woman Owned:
N
Duns:
n/a
Principal Investigator:
GARYHAVEY
(763) 463-4814
GHAVEY@AME-CORP.COM
Business Contact:
THOMASHENDRICKSON
(763) 463-4814
thendrickson@ame-corp.com
Research Institute:
n/a
Abstract
DESCRIPTION (provided by applicant): This project seeks to develop a device to electronically record self-report data on menopausal symptomatology in conjunction with data from a sternal skin conductance monitor. The combined collection of these two symptom recording modalities will provide researchers with powerful datasets to asses and interpret menopause symptoms in advanced research studies. Advanced Medical Electronics Corporation (AME) will collaborate with clinical investigators at the Mayo Clinic experienced in the use of self-report instruments for recording menopause symptoms. The proposed self-report recording device will be constructed using unobtrusive and inexpensive handheld computer technology. A sternal skin conductance monitor developed at AME will be modified to allow wireless transfer of data to the handheld computer for storage alongside the self-report records in a unified database. The handheld computer will automatically acquire data from the sternal skin conductance monitor without patient action. The use of this wireless link to the conductance monitor is innovative and will allow simpler collection of both sternal skin conductance measurements and self-reported symptom data. A human pilot study with the new system will be performed at the Mayo Clinic in Rochester, Minnesota. Complimentary and alternative medicine (CAM) therapies for hot flashes have been practiced for a long time. However, few empirical studies have thoroughly evaluated the safety and efficacy of many of these treatment modalities. Future research studies will be designed and conducted to evaluate the safety and efficacy of new and modified hot flash therapies. Better tools for measuring and recording hot flashes in research subjects, both in a laboratory and ambulatory settings, are needed to support this important research area.

* information listed above is at the time of submission.

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