Validation of an Objective Instrument to Measure Hot Flashes During Menopause

Study Overview
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Brief Summary
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The overarching aim of this study is to assess the validity of the iButton®, a dual temperature and humidity sensing device (DS1923; Maxim IntegratedTM), as an objective method to assess hot flash incidence and dynamics in both a real world (ambulatory) and controlled (laboratory) setting. This study will test the overarching hypothesis that both self-report hot flashes in both an ambulatory and laboratory setting will correlate (confirm) the temperature and humidity sensing observed via the iButton® technology.

Detailed Description
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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.

Official Title
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Validation of an Objective Instrument to Measure Hot Flashes During Menopause

Conditions
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Menopause, Hot Flashes

Intervention / Treatment
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* Device: iButton®


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 45 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| iButton® Validation in Perimenopause<br>Women in the late phase of perimenopause (based on the STRAW+10 criteria). | Device: iButton®<br>* Women with frequently reported hot flashes will be undergo both real world (ambulatory; field tests) and controlled (laboratory) assessments to validate the iButton® as an objective method to assess hot flash dynamics and incidence.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Skin temperature (via iButton®) | Skin temperatures will be continually monitored at 2 sites: the sternum (chest) and forearm, using iButton® technology during a single hot flash that is stimulated at the laboratory visit. | 2 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Skin temperature (via BIOPAC) | Skin temperatures will be continually monitored at 5 sites: the mid-thigh, sternum (chest), forearm, mid-biceps, and scapula, during a single hot flash that is stimulated at the laboratory visit. | 2 hours | 
| Skin blood flow (via laser-Doppler flowmetry) | Skin blood flow will be measured continuously using a laser Doppler flowmeter on the sternum with the associated software (Perimed, Stockholm, Sweden) during a single hot flash that is stimulated at the laboratory visit. | 2 hours | 
| Core temperature (via pill telemetry) | Core temperature will be measured from an ingestible pill telemetry system (HTI Technologies; Palmetto, FL) during a single hot flash that is stimulated at the laboratory visit. | 2 hours | 
| Sweat rate (via ventilated capsule) | Sweat rates of the sternum and forearm will be measured using ventilated capsules secured with surgical adhesive during a single hot flash that is stimulated at the laboratory visit. | 2 hours |