Skin Conduction Device 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

Identifiers

NCT00427622

MC05CC (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 comparing a skin conduction device with a hot flash diary as a way of measuring hot flashes in postmenopausal women with hot flashes.

Full description

OBJECTIVES:

• Correlate hot flash frequency, as measured by an ambulatory sternal skin conductance measuring and recording tool, with patient-recorded hot flash frequency using a hot flash diary in postmenopausal women with hot flashes.
• Determine the comfort, obtrusiveness, and feasibility of using the skin conductance recording tool for measuring hot flashes when worn daily for five weeks in these patients.

OUTLINE: Patients wear an ambulatory sternal skin conductance hot flash device continuously for 5 weeks.

Patients complete hot flash diaries once daily for 5 weeks. Patients also complete the Comfort, Bother, and Weight Questionnaire at the end of week 5.

PROJECTED ACCRUAL: A total of 25 patients will be accrued for this study.

Enrollment: 25 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

DISEASE CHARACTERISTICS:

• Diagnosis of bothersome hot flashes, defined by their occurrence of ≥ 4 times/day

  • Daily hot flashes 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
• Willing to record hot flashes in a hot flash diary daily for 5 weeks
• Willing to wear a skin conductance device 24 hours a day for 5 weeks
• No implanted pacemakers or metal implants
• No reliance on other electronic devices for regular monitoring (i.e., insulin pumps or blood pressure monitors)

PRIOR CONCURRENT THERAPY:

• Not specified