Validation of an Objective Instrument to Measure Hot Flashes During Menopause

NCT03642119 | Terminated

• 1 other identifier: PBRC 2018-027
• Study Type: observational
• Target: 12
• Locations: 1 country
• Sites: 1

Brief 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

Menopause; Hot Flashes

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Skin temperature (via BIOPAC)

  2 hours

• Skin blood flow (via laser-Doppler flowmetry)

  2 hours

• Core temperature (via pill telemetry)

  2 hours

• Sweat rate (via ventilated capsule)

  2 hours

Study Arms (1)

iButton® Validation in Perimenopause

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

Device: iButton®

Interventions

iButton® DEVICE

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.

iButton® Validation in Perimenopause

Eligibility Criteria

• Age: 45 Years - 60 Years
• Gender Eligibility Details: Women in the late-phase of perimenopause with frequent hot flashes.
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Pennington Biomedical Research Center: lead

Study Sites (1)

Pennington Biomedical Research Center

Baton Rouge, Louisiana, 70808, United States

Location

MeSH Terms

Conditions

Hot Flashes

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Kara L Marlatt, PhD, MPH

  Pennington Biomedical Research Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 9, 2018
• First Posted: August 22, 2018
• Study Start: September 7, 2018
• Primary Completion: September 19, 2022
• Study Completion: September 19, 2022
• Last Updated: February 2, 2023

Record last verified: 2022-09

Locations

US (1)