Skin Conduction Device for Measuring Hot Flashes in Postmenopausal Women With Hot Flashes

Study Overview
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Brief Summary
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RATIONALE: Measuring how often hot flashes occur in postmenopausal women may be done by using a skin conduction device or by using a diary. PURPOSE: This clinical trial is comparing a skin conduction device with a hot flash diary as a way of measuring hot flashes in postmenopausal women with hot flashes.

Detailed Description
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OBJECTIVES: Correlate hot flash frequency, as measured by an ambulatory sternal skin conductance measuring and recording tool, with patient-recorded hot flash frequency using a hot flash diary in postmenopausal women with hot flashes. Determine the comfort, obtrusiveness, and feasibility of using the skin conductance recording tool for measuring hot flashes when worn daily for five weeks in these patients. OUTLINE: Patients wear an ambulatory sternal skin conductance hot flash device continuously for 5 weeks. Patients complete hot flash diaries once daily for 5 weeks. Patients also complete the Comfort, Bother, and Weight Questionnaire at the end of week 5. PROJECTED ACCRUAL: A total of 25 patients will be accrued for this study.

Official Title
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A Trial to Examine the Accuracy of an Ambulatory Sternal Skin Conductance Recording Tool to Measure Hot Flashes

Conditions
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Hot Flashes

Intervention / Treatment
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* Other: physiologic testing


Participation Criteria
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Eligibility Criteria
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DISEASE CHARACTERISTICS: Diagnosis of bothersome hot flashes, defined by their occurrence of ≥ 4 times/day Daily hot flashes have been present for ≥ 1 month PATIENT CHARACTERISTICS: Female Postmenopausal ECOG performance status 0-1 No history of allergic or other adverse reactions to adhesives No other medical condition known to cause sweating and/or flushing Willing to record hot flashes in a hot flash diary daily for 5 weeks Willing to wear a skin conductance device 24 hours a day for 5 weeks No implanted pacemakers or metal implants No reliance on other electronic devices for regular monitoring (i.e., insulin pumps or blood pressure monitors) PRIOR CONCURRENT THERAPY: Not specified

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: physiologic testing|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Correlation of hot flash frequency, as measured by an ambulatory sternal skin conductance measuring and recording tool, with patient-recorded hot flash frequency using a hot flash diary |  |  | 
| Comfort, obtrusiveness, and feasibility of using the skin conductance recording tool |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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hot flashes