Thermoregulatory Physiology of Menopausal Hot Flashes
ConditionMenopause Hot Flashes
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age40-65
SponsorSRI International
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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;
Trial design
Design model
Crossover
Treatments tested in this trial
Intervention C (Targeted skin cooling)
Other interventionCooling targeted to the skin during a hot flash
Intervention B (Ambient cooling)
Other interventionCooling of the room
Intervention A (Room temperature)
Other interventionControl condition (room temperature)
Treatment groups
40 Participants
are divided into 3 treatment groupsGroup A: Sequence A-B-CExperimental treatment 3 interventions
Group B: Sequence B-C-AExperimental treatment 3 interventions
Group C: Sequence C-A-BExperimental treatment 3 interventions
Trial outcomes
Primary outcomes
1
Number of hot flashes
Number of hot flashes, based on sternal skin conductance measurement
Time frame
Across the ~5 hour experimental period in the labSponsors and contacts
Click on the lead sponsor to view all of their trials.
SRI International
Lead sponsor
National Institute on Aging (NIA)
Collaborator
Stanford University
Collaborator
Source ClinicalTrials.gov