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

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
Mayo Clinic
ClinicalTrials.gov Identifier:
NCT00427531
First received: January 25, 2007
Last updated: March 16, 2011
Last verified: March 2011
  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 [ Designated as safety issue: No ]
  • Hot flash recordings as measured by an ambulatory sternal skin conductance measuring and recording tool during a 30-minute exercise period [ Designated as safety issue: No ]

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00427531

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

Additional Information:
No publications provided

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, MC06C3, 06-002452
Study First Received: January 25, 2007
Last Updated: March 16, 2011
Health Authority: United States: Federal Government

Keywords provided by Mayo Clinic:
hot flashes

Additional relevant MeSH terms:
Hot Flashes
Signs and Symptoms

ClinicalTrials.gov processed this record on September 16, 2014