Ignite Creation Date:
2024-05-05 @ 5:16 PM
Last Modification Date:
2024-10-26 @ 9:30 AM
Study NCT ID:
NCT00427622
Status:
COMPLETED
Last Update Posted:
2014-04-09
First Post:
2007-01-25
Brief Title:
Skin Conduction Device for Measuring Hot Flashes in Postmenopausal Women With Hot Flashes
Sponsor:
Mayo Clinic
Organization:
Mayo Clinic
Study Overview
Official Title:
A Trial to Examine the Accuracy of an Ambulatory Sternal Skin Conductance Recording Tool to Measure Hot Flashes
Status:
COMPLETED
Status Verified Date:
2007-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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:
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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| MC05CC | OTHER | Mayo Clinic Cancer Center | None |