Skin Conduction Device and Patient Diary 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 studying a skin conduction device and a patient diary for measuring hot flashes in postmenopausal women with hot flashes.

Detailed Description
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OBJECTIVES: Determine the differences in frequency, severity, and duration of hot flash activity using an ambulatory sternal skin conductance recording tool and patient hot flash diary in postmenopausal women with hot flashes. Assess the recordings made by an ambulatory sternal skin conductance measuring and recording tool during a 30-minute exercise period in these patients. OUTLINE: Patients wear an ambulatory sternal skin conductance hot flash device continuously for 24 hours. Patients complete hot flash diaries over 24 hours. Patients undergo treadmill exercise over 30 minutes and record hot flash activity using the skin conductance device during 10 minutes of sweating. Patients also complete the Comfort, Bother, and Weight Questionnaire at the completion of the study. PROJECTED ACCRUAL: A total of 3 patients will be accrued for this study.

Official Title
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An Exploratory Trial to Examine the Accuracy of Various Hot Flash Variables With an Ambulatory Sternal Skin Conductance Recording Tool

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 ≥ 4 times/day Daily hot flashes that 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 No implanted pacemakers or metal implants No reliance on 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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All

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


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 |
| --- | --- | --- |
| Differences in frequency, severity, and duration of hot flash activity using an ambulatory sternal skin conductance recording tool and patient hot flash diary |  |  | 
| Hot flash recordings as measured by an ambulatory sternal skin conductance measuring and recording tool during a 30-minute exercise period |  |  | 

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