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Clinical Trial
. 2007 Aug;88(2):494-6.
doi: 10.1016/j.fertnstert.2006.11.184. Epub 2007 Apr 18.

Miniature hygrometric hot flash recorder

Robert R Freedman  1 , Samuel Wasson
Affiliations
Clinical Trial

Miniature hygrometric hot flash recorder

Robert R Freedman et al. Fertil Steril. 2007 Aug.

Abstract

Objective: To design and test a miniature ambulatory hot flash recorder that uses neither electrodes nor gel.

Design: In the first study, putative hot flashes recorded by using a relative humidity sensor were compared with patient event marks. In the second study, relative humidity recorded by using a complete prototype recorder was compared with sternal skin conductance recordings made on a Biolog recorder, as well as with event marks.

Setting: University medical center.

Patient(s): Ten healthy postmenopausal women reporting frequent hot flashes and using no medication.

Intervention(s): Body heating in laboratory.

Main outcome measure(s): Positive predictive value (PPV), sensitivity, specificity.

Result(s): In both laboratory studies, the PPV, sensitivity, and specificity among all three measures (relative humidity, skin conductance level, event) were 100%. In the field, a relative humidity increase of 3% per minute compared with skin conductance level-detected hot flashes yielded a PPV of 95.6%, a specificity of 95.2%, and a sensitivity of 90.9%.

Conclusion(s): This device should be useful as an endpoint in clinical trials of treatments for hot flashes.

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Figures

Fig. 1
Fig. 1
Prototype humidity sensor.
Fig. 2
Fig. 2
Prototype hot flash recorder. Weight = 14 gm. Scale in cm.
See this image and copyright information in PMC

References

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