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The overarching aim of this study is to assess the validity of the iButtonĀ®, 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 iButtonĀ® technology.
Using iButtonĀ® 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 iButtonĀ® 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 iButtonĀ® 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 iButtonĀ® to correlate (confirm) the observed thermoregulatory changes and further assess validity. To date, existing studies using iButtonsĀ® 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 iButtonsĀ®) 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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| iButtonĀ® Validation in Perimenopause | Women in the late phase of perimenopause (based on the STRAW+10 criteria). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| iButtonĀ® | Device | Women with frequently reported hot flashes will be undergo both real world (ambulatory; field tests) and controlled (laboratory) assessments to validate the iButtonĀ® as an objective method to assess hot flash dynamics and incidence. |
| Measure | Description | Time Frame |
|---|---|---|
| Skin temperature (via iButtonĀ®) | Skin temperatures will be continually monitored at 2 sites: the sternum (chest) and forearm, using iButtonĀ® technology during a single hot flash that is stimulated at the laboratory visit. | 2 hours |
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
Women in the late-phase of perimenopause with frequent hot flashes.
Women who are in the late phase of perimenopause (based on the STRAW+10 criteria).
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| Name | Affiliation | Role |
|---|---|---|
| Kara L Marlatt, PhD, MPH | Pennington Biomedical Research Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pennington Biomedical Research Center | Baton Rouge | Louisiana | 70808 | United States |
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| ID | Term |
|---|---|
| D019584 | Hot Flashes |
| ID | Term |
|---|---|
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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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 |