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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00427531
First Posted: January 29, 2007
Last Update Posted: March 17, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
National Cancer Institute (NCI)
Information provided by:
Mayo Clinic
  Purpose

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.


Condition Intervention
Hot Flashes Other: physiologic testing

Study Type: Interventional
Study Design: Primary Purpose: Diagnostic
Official Title: An Exploratory Trial to Examine the Accuracy of Various Hot Flash Variables With an Ambulatory Sternal Skin Conductance Recording Tool

Further study details as provided by Mayo Clinic:

Primary Outcome Measures:
  • 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

Estimated Enrollment: 3
Study Start Date: June 2006
Study Completion Date: September 2006
Primary Completion Date: September 2006 (Final data collection date for primary outcome measure)
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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00427531


Locations
United States, Minnesota
Mayo Clinic
Rochester, Minnesota, United States, 55905
Sponsors and Collaborators
Mayo Clinic
National Cancer Institute (NCI)
Investigators
Study Chair: Debra L. Barton, R.N., Ph.D. Mayo Clinic
  More Information

Responsible Party: Debra L. Barton, R.N., Ph.D., Mayo Clinic Cancer Center
ClinicalTrials.gov Identifier: NCT00427531     History of Changes
Other Study ID Numbers: CDR0000525737
P30CA015083 ( U.S. NIH Grant/Contract )
MC06C3 ( Other Identifier: Mayo Clinic Cancer Center )
06-002452 ( Other Identifier: Mayo Clinic IRB )
First Submitted: January 25, 2007
First Posted: January 29, 2007
Last Update Posted: March 17, 2011
Last Verified: March 2011

Keywords provided by Mayo Clinic:
hot flashes

Additional relevant MeSH terms:
Hot Flashes
Signs and Symptoms