An Exploratory Trial to Examine the Accuracy of Various Hot Flash Variables With an Ambulatory Sternal Skin Conductance Recording Tool
18 Years
N/A
Both
Hot Flashes
Trial Information
An Exploratory Trial to Examine the Accuracy of Various Hot Flash Variables With an Ambulatory Sternal Skin Conductance Recording Tool
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.
Inclusion Criteria
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
Type of Study:
Interventional
Study Design:
Primary Purpose: Diagnostic
Outcome Measure:
Differences in frequency, severity, and duration of hot flash activity using an ambulatory sternal skin conductance recording tool and patient hot flash diary
Safety Issue:
No
Principal Investigator
Debra L. Barton, R.N., Ph.D.
Investigator Role:
Study Chair
Investigator Affiliation:
Mayo Clinic
Authority:
United States: Federal Government
Study ID:
CDR0000525737
NCT ID:
NCT00427531
Start Date:
June 2006
Completion Date:
September 2006
Related Keywords:
- Hot Flashes
- hot flashes
- Hot Flashes
Name | Location |
|---|---|
| Mayo Clinic | Rochester, Minnesota 55905 |
