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

Hot Flashes Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00427531
• Other study ID #: CDR0000525737
• Secondary ID: P30CA015083MC06C
• Status: Completed
• Phase: N/A
• First received: January 25, 2007
• Last updated: March 16, 2011
• Start date: June 2006
• Est. completion date: September 2006

Study information

• Verified date: March 2011
• 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 studying a skin conduction device and a patient diary for measuring hot flashes in postmenopausal women with hot flashes.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 3
• Est. completion date: September 2006
• Est. primary completion date: September 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Hot Flashes

Intervention

Other:
• physiologic testing

Locations

Country	Name	City	State
United States	Mayo Clinic	Rochester	Minnesota

Sponsors (2)

Lead Sponsor	Collaborator
Mayo Clinic	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Differences in frequency, severity, and duration of hot flash activity using an ambulatory sternal skin conductance recording tool and patient hot flash diary			No
Primary	Hot flash recordings as measured by an ambulatory sternal skin conductance measuring and recording tool during a 30-minute exercise period			No