Back to resultsSkin Conduction Device for Measuring Hot Flashes in Postmenopausal Women With Hot Flashes
Primary Purpose
Hot Flashes
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
physiologic testing
Sponsored by
About this trial
This is an interventional diagnostic trial for Hot Flashes focused on measuring hot flashes
Eligibility Criteria
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
Sites / Locations
- Mayo Clinic Cancer Center
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00427622
Brief Title
Skin Conduction Device for Measuring Hot Flashes in Postmenopausal Women With Hot Flashes
Official Title
A Trial to Examine the Accuracy of an Ambulatory Sternal Skin Conductance Recording Tool to Measure Hot Flashes
Study Type
Interventional
2. Study Status
Record Verification Date
June 2007
Overall Recruitment Status
Completed
Study Start Date
May 2006 (undefined)
Primary Completion Date
June 2007 (Actual)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Mayo Clinic
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hot Flashes
Keywords
hot flashes
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Masking
None (Open Label)
Enrollment
25 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Other
Intervention Name(s)
physiologic testing
Primary Outcome Measure Information:
Title
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
Title
Comfort, obtrusiveness, and feasibility of using the skin conductance recording tool
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Debra Barton, RN, PhD, AOCN, FAAN
Organizational Affiliation
Mayo Clinic
Official's Role
Study Chair
Facility Information:
Facility Name
Mayo Clinic Cancer Center
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Skin Conduction Device for Measuring Hot Flashes in Postmenopausal Women With Hot Flashes
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