Recruiting

Cooling

Sponsor:

SRI International

Code:

NCT07824648

Conditions

Menopause Hot Flashes

Eligibility Criteria

Sex: Female

Age: 40 - 65

Healthy Volunteers: Not accepted

Interventions

Intervention C (Targeted skin cooling)

Intervention B (Ambient cooling)

Intervention A (Room temperature)

Study Details

Brief summary:

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.

Conditions

Menopause Hot Flashes

Study ID

NCT07824648

Start date

May 5, 2026

Status verified date

Sep, 2026

Completion date

Sep 15, 2027

Anticipated

Primary completion date

Sep 15, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 40 - 65

Healthy Volunteers: Not accepted

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

Enrollment

40 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Basic Science

Interventions and Outcome Measures

Arms

experimental: Sequence A-B-C

Laboratory interventions are administered in the order of Room Temperature-Ambient Cooling-Targeted skin cooling

experimental: Sequence B-C-A

Laboratory interventions are administered in order of Ambient cooling-Targeted skin cooling-Room temperature

experimental: Sequence C-A-B

Laboratory interventions are administered in the order of Targeted skin cooling-Room temperature-Ambient cooling

Interventions

Intervention C (Targeted skin cooling)

Cooling targeted to the skin during a hot flash

Intervention B (Ambient cooling)

Cooling of the room

Intervention A (Room temperature)

Control condition (room temperature)

Primary outcome measure

  • Number of hot flashes [ Time Frame: Across the ~5 hour experimental period in the lab ]

Central Contacts and Locations

Locations

SRI International

Recruiting

Menlo Park, California, United States, 94025-3453

Contacts

Fiona Baker

6508593062fiona.baker@sri.com

More Information

Sponsor

SRI International

Last update posted

Sep 17, 2026

Last verified

Sep, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-18. This information was provided to ClinicalTrials.gov by SRI International on 2026-09-17.