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

Mayo Clinic

Status: Completed

Conditions: Hot Flashes

Treatments: Other: physiologic testing

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT00427531

P30CA015083 (U.S. NIH Grant/Contract)

06-002452 (Other Identifier)

CDR0000525737

MC06C3 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 3 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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