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

Hot Flashes Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00427622
• Other study ID #: MC05CC
• Secondary ID: MC05CC
• Status: Completed
• Phase: N/A
• First received: January 25, 2007
• Last updated: April 7, 2014
• Start date: May 2006

Study information

• Verified date: June 2007
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. primary completion date: June 2007
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Study Design

Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Hot Flashes

Intervention

Other:
• physiologic testing

Locations

Country	Name	City	State
United States	Mayo Clinic Cancer Center	Rochester	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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			No
Primary	Comfort, obtrusiveness, and feasibility of using the skin conductance recording tool			No