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Skin Conduction Device and Patient Diary for Measuring Hot Flashes in Postmenopausal Women With Hot Flashes

An Exploratory Trial to Examine the Accuracy of Various Hot Flash Variables With an Ambulatory Sternal Skin Conductance Recording Tool

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00427531
Enrollment
3
Registered
2007-01-29
Start date
2006-06-30
Completion date
2006-09-30
Last updated
2011-03-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hot Flashes

Keywords

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 studying a skin conduction device and a patient diary for measuring hot flashes in postmenopausal women with hot flashes.

Detailed description

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.

Interventions

OTHERphysiologic testing

Sponsors

National Cancer Institute (NCI)
CollaboratorNIH
Mayo Clinic
Lead SponsorOTHER

Study design

Primary purpose
DIAGNOSTIC

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Differences in frequency, severity, and duration of hot flash activity using an ambulatory sternal skin conductance recording tool and patient hot flash diary
Hot flash recordings as measured by an ambulatory sternal skin conductance measuring and recording tool during a 30-minute exercise period

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026