Validation of an Objective Instrument to Measure Hot Flashes During Menopause

Using iButton® technology as an objective instrument to measure hot flash dynamics, the
investigators will validate the technology in 12 perimenopausal women ages 45-60 y and BMI
18.5-40 kg/m2 who experience greater than or equal to 4 hot flashes per day. First, the
investigators will validate the iButton® technology against self-report (subjective) hot
flash incidence in a real world, ambulatory condition (via a hot flash journal). Next, the
investigators will validate the iButton® technology during a controlled,
laboratory-stimulated hot flash using a tube-lined suit that circulates warm water uniformly
around the lower limbs (Med-EngTM). During the stimulated hot flash, the investigators will
simultaneously measure core body temperature, skin blood flow, skin temperature, sweat rate,
and heart rate alongside the iButton® to correlate (confirm) the observed thermoregulatory
changes and further assess validity. To date, existing studies using iButtons® to assess
changes in skin temperature have been conducted.

Each subject will undergo a two-phased screening to determine eligibility. Pre-enrollment
measurements will include standard anthropometrics (weight, height), vital signs (blood
pressure, heart rate), fasting blood draw, and questionnaires, as well as a 7-day hot flash
journal that captures frequency and severity screening. Post-enrollment measurements will
include simultaneous objective (via iButtons®) and subjective (via self-report journal) hot
flash recordings (i.e., field testing), as well as a final laboratory visit will be conducted
at Louisiana State University's School of Kinesiology and include body composition
assessment, as well as the following assessments during a stimulated hot flash -- core
temperature, skin blood flow, skin temperature, sweat rate, and heart rate.

Inclusion Criteria:

- Healthy female

- Ages 45-60 y

- BMI between 18.5 kg/m2 and 40 kg/m2 (inclusive)

- Self-reported ≥4 hot flashes per day (for 4 out of the 7 days) (via 7-d hot flash
journal)

- Meets both criteria for "peri-menopause (late phase)" classification: (1) experiences
menopause-related symptoms (including hot flashes); (2) has hot gone 12 months in a
row without a menstrual cycle; however, has sometimes more than 60 days between
cycles.

- Medically cleared for participation by the Medical Investigator

Exclusion Criteria:

- Current smokers, or having smoked within the last 3 months

- History of diabetes (or other metabolic diseases)

- History of neurological disease

- History of cardiovascular disease

- Taking hormone replacement therapy, or other therapies/supplements designed to reduce
severity of menopause symptoms (e.g., hot flashes)

- Pregnant, planning to become pregnant, or currently breastfeeding