Clinical Trial: Skin Conduction Device for Measuring Hot Flashes in Postmenopausal Women With Hot Flashes

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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

Brief Summary:

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 Summary:

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.


Sponsor: Mayo Clinic

Current Primary Outcome:

  • 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


Original Primary Outcome:

Current Secondary Outcome:

Original Secondary Outcome:

Information By: Mayo Clinic

Dates:
Date Received: January 25, 2007
Date Started: May 2006
Date Completion:
Last Updated: April 7, 2014
Last Verified: June 2007