Validation of an Objective Instrument to Measure Hot Flashes During Menopause (FLAME)

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.

Study Overview

• Status: Terminated
• Conditions: Hot Flashes; Menopause
• Intervention / Treatment: Device: iButton®

Detailed Description

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.

• Study Type: Observational
• Enrollment (Actual): 12

Contacts and Locations

Study Locations

• United States
  • Louisiana
    • Baton Rouge, Louisiana, United States, 70808
      • Pennington Biomedical Research Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 45 years to 60 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

Women who are in the late phase of perimenopause (based on the STRAW+10 criteria).

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
iButton® Validation in Perimenopause; Women in the late phase of perimenopause (based on the STRAW+10 criteria).	Device: iButton®; 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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Pennington Biomedical Research Center

Study record dates

Study Major Dates

• Study Start (Actual): September 7, 2018
• Primary Completion (Actual): September 19, 2022
• Study Completion (Actual): September 19, 2022

Study Registration Dates

• First Submitted: August 9, 2018
• First Submitted That Met QC Criteria: August 20, 2018
• First Posted (Actual): August 22, 2018

Study Record Updates

• Last Update Posted (Actual): February 2, 2023
• Last Update Submitted That Met QC Criteria: January 31, 2023
• Last Verified: September 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Hot Flashes
• Other Study ID Numbers: PBRC 2018-027

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No