Skip to main content
OpenTrials
Completed

NCT Number: NCT02795741

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

The Cooling Bolero is a a vest filled with a new material (not ice or a gel) that provides controlled cooling by absorbing 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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Englewood Hospital and Medical Center

Englewood, New Jersey, 07631, United States

About this study

Participants who have consented for this study will first be asked to complete a Baseline Assessment of their menopausal symptoms, including documentation of their baseline weight. If the assessment indicates that the participant has at least 'moderate' menopausal symptoms, then she will then enter the Run-In Period.

During the two-week Run-In Period, participants will use a Symptom Diary for to document the frequency and severity of their menopausal symptoms. At the start of Week 3, participants will return their completed Run-In Period Symptom Diary and receive their Cooling Bolero with instructions on how to use the product during the Treatment Period.

During the Treatment Period, participants should use the Cooling Bolero at least two times per day (morning and evening) for one hour. As feasible, the participant should start to wear the product 30 minutes prior to meal time for these two applications. The participant may also wear the product at additional times, as desired. All applications of the Cooling Bolero during the four-week Treatment Period are to be documented in the Product/Symptom Diary. During the Treatment Period, the participant will also continue to document the frequency and severity of their menopausal symptoms in the Product/Symptom Diary.

At the end of Week 6, the participant will stop using the Cooling Bolero. She will be asked to complete a Product Assessment and have her weight documented.

Participants will be contacted at Week 10 to ask about the status of menopausal symptoms after four weeks of not using the Cooling Bolero.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Has another existing medical condition that would prevent study compliance.

Treatment and study plan

Cooling Bolero

Device

a vest filled with a new material (not ice or a gel) that provides controlled cooling by absorbing heat

Primary outcomes

  1. Number of participants with a reduction in the frequency and/or intensity of menopause symptoms

    Time frame: one month

    Diaries will be used to capture data pre-intervention, during the intervention, and post-intervention

Sponsors and collaborators

Lead sponsor

Englewood Hospital and Medical Center

Other

Collaborators

  • Nanohealth, Inc.

Registry information

Official study title

Pilot Study to Evaluate the Effects of the Nanohealth, Inc. Cooling Bolero in Women With Common Menopause Symptoms

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Jun 10, 2016
Registry last updated
Jun 14, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.