NCT03642119

Validation of an Objective Instrument to Measure Hot Flashes During Menopause

• Status: Terminated
• Phase: —
• Study type: Observational
• Enrollment: 12 (actual)
• Sponsor: Pennington Biomedical Research Center · Academic / Other
• Sex: Female
• Age: 45 Years – 60 Years
• Healthy volunteers: Accepted

Summary

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

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.

Conditions

• Menopause
• Hot Flashes

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2018-09-07
• Primary completion: 2022-09-19
• Completion: 2022-09-19
• First posted: 2018-08-22
• Last updated: 2023-02-02

Locations

1 site across 1 country: United States