Skin Conduction Device for Measuring Hot Flashes in Postmenopausal Women With Hot Flashes

A Trial to Examine the Accuracy of an Ambulatory Sternal Skin Conductance Recording Tool to Measure Hot Flashes

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00427622

Enrollment

Registered

2007-01-29

Start date

2006-05-31

Completion date

Unknown

Last updated

2014-04-09

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 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.

Interventions

OTHERphysiologic testing

Study design

Primary purpose

DIAGNOSTIC

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to No maximum

Healthy volunteers

Inclusion 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

Design outcomes

Primary

Measure	Time frame
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	—

Countries

United States

Outcome results

None listed

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