Skin Conduction Device and Patient Diary for Measuring Hot Flashes in Postmenopausal Women With Hot Flashes
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.
|Study Design:||Primary Purpose: Diagnostic|
|Official Title:||An Exploratory Trial to Examine the Accuracy of Various Hot Flash Variables With an Ambulatory Sternal Skin Conductance Recording Tool|
- Differences in frequency, severity, and duration of hot flash activity using an ambulatory sternal skin conductance recording tool and patient hot flash diary [ Designated as safety issue: No ]
- Hot flash recordings as measured by an ambulatory sternal skin conductance measuring and recording tool during a 30-minute exercise period [ Designated as safety issue: No ]
|Study Start Date:||June 2006|
|Study Completion Date:||September 2006|
|Primary Completion Date:||September 2006 (Final data collection date for primary outcome measure)|
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00427531
|United States, Minnesota|
|Rochester, Minnesota, United States, 55905|
|Study Chair:||Debra L. Barton, R.N., Ph.D.||Mayo Clinic|