Thermoregulatory Physiology of Menopausal Hot Flashes

Purpose

This study is evaluating the effects of cooling on menopausal hot flashes in midlife women. Precise targeted cooling is provided to areas of the skin when a hot flash occurs.

Condition

  • Menopause Hot Flashes

Eligibility

Eligible Ages
Between 40 Years and 65 Years
Eligible Sex
Female
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Female - Age range: 40 to 65 years and in menopausal transition or post-menopause; - At least 8 years of education to ensure adequate reading proficiency; - Primary language is English or Spanish.

Exclusion Criteria

  • History of medical or neurological illness or trauma that would affect the central nervous system (e.g., stroke, multiple sclerosis, epilepsy); - Current severe medical conditions (e.g. Diabetes, cancer, cardiovascular disease, renal or hepatic disease, thyroid disorders); - History of schizophrenia and/or bipolar disorder; - Dependence or abuse of illicit substances in the past year; - Current use of hormone therapy or other treatments for hot flash symptoms

Study Design

Phase
N/A
Study Type
Interventional
Allocation
Randomized
Intervention Model
Crossover Assignment
Intervention Model Description
There are three temperature interventions, each participant may be exposed to during the study: room temperature, ambient cooling, targeted skin cooling
Primary Purpose
Basic Science
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Sequence A-B-C 		Laboratory interventions are administered in the order of Room Temperature-Ambient Cooling-Targeted skin cooling
  • Other: Intervention C (Targeted skin cooling)
    Cooling targeted to the skin during a hot flash
  • Other: Intervention B (Ambient cooling)
    Cooling of the room
  • Other: Intervention A (Room temperature)
    Control condition (room temperature)
Experimental
Sequence B-C-A 		Laboratory interventions are administered in order of Ambient cooling-Targeted skin cooling-Room temperature
  • Other: Intervention C (Targeted skin cooling)
    Cooling targeted to the skin during a hot flash
  • Other: Intervention B (Ambient cooling)
    Cooling of the room
  • Other: Intervention A (Room temperature)
    Control condition (room temperature)
Experimental
Sequence C-A-B 		Laboratory interventions are administered in the order of Targeted skin cooling-Room temperature-Ambient cooling
  • Other: Intervention C (Targeted skin cooling)
    Cooling targeted to the skin during a hot flash
  • Other: Intervention B (Ambient cooling)
    Cooling of the room
  • Other: Intervention A (Room temperature)
    Control condition (room temperature)

Recruiting Locations

SRI International
Menlo Park, California 94025-3453
Contact:
Fiona Baker
6508593062
fiona.baker@sri.com

More Details

Status
Recruiting
Sponsor
SRI International

Study Contact