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

March 16, 2011 updated by: Mayo Clinic

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

3

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • Mayo Clinic

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: DIAGNOSTIC

What is the study measuring?

Primary Outcome Measures

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
Hot flash recordings as measured by an ambulatory sternal skin conductance measuring and recording tool during a 30-minute exercise period

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mayo Clinic

Collaborators

National Cancer Institute (NCI)

Investigators

  • Study Chair: Debra L. Barton, R.N., Ph.D., Mayo Clinic

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2006

Primary Completion (ACTUAL)

September 1, 2006

Study Completion (ACTUAL)

September 1, 2006

Study Registration Dates

First Submitted

January 25, 2007

First Submitted That Met QC Criteria

January 26, 2007

First Posted (ESTIMATE)

January 29, 2007

Study Record Updates

Last Update Posted (ESTIMATE)

March 17, 2011

Last Update Submitted That Met QC Criteria

March 16, 2011

Last Verified

March 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CDR0000525737
  • P30CA015083 (U.S. NIH Grant/Contract)
  • MC06C3 (OTHER: Mayo Clinic Cancer Center)
  • 06-002452 (OTHER: Mayo Clinic IRB)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Hot Flashes

Clinical Trials on physiologic testing

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Mauritius

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe