Study to Evaluate the Effects of the Cooling Bolero in Women With Menopause Symptoms

Withdrawn before enrolling · Not applicable

Conditions studied: Menopause Symptoms

In brief

The Cooling Bolero is a vest filled with a new material (not ice or a gel) that provides controlled cooling by absorbed heat. The vest is manufactured by Nanohealth. It intended to provide moderate cooling (\~15C/59F) through indirect contact with the skin. The material in the device is safe, non-toxic, and eco-friendly. Recent anecdotal studies of women with common peri-menopausal and menopausal symptoms (hot flashes, night sweats, flushing/sweating of face and neck, and intermittent sleep disturbances) have shown a reduction in both the frequency and intensity of those symptoms after using the Cooling Bolero. Specific (moderate) temperature cooling of the neck and upper torso appears to target and mitigate these common menopausal symptoms. This pilot study attempts to collect additional data on the effects of the Cooling Bolero.

Key facts

Study ID

NCT04124783

Run by

Englewood Hospital and Medical Center

People needed

0

Starts

2019-10-23

Expected to finish

2020-12-23

Last updated by the study team

2021-01-05

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• Female who is at least 18 years old
• Self-reports having at least two (2) daily hot flashes associated with menopause

You may not qualify if…

• Taking hormonal therapy (currently or within the last 3 months).
• Has another existing medical condition that would prevent study compliance.

Where it is running

• Englewood Health — Englewood, New Jersey, United States

Full record on ClinicalTrials.gov

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