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Validation of an Objective Instrument to Measure Hot Flashes During Menopause

NCT03642119 · Status: TERMINATED · Type: OBSERVATIONAL · Enrollment: 12

Last updated 2023-02-02

No results posted yet for this study

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.

Conditions

Interventions

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.

Sponsors & Collaborators

  • Pennington Biomedical Research Center

    lead OTHER

Principal Investigators

  • Kara L Marlatt, PhD, MPH · Pennington Biomedical Research Center

Eligibility

Min Age
45 Years
Max Age
60 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-09-07
Primary Completion
2022-09-19
Completion
2022-09-19

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03642119 on ClinicalTrials.gov