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

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

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.

Study Overview

• Status: Withdrawn
• Conditions: Menopause Symptoms
• Intervention / Treatment: Device: Cooling Bolero

Detailed Description

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

• Study Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New Jersey
    • Englewood, New Jersey, United States, 07631
      • Englewood Health

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Cooling Bolero	Device: Cooling Bolero; A vest filled with a new material (not ice or a gel) that provides controlled cooling by absorbing heat

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of participants with a reduction in the frequency and/or intensity of menopause symptoms	Diaries will be used to capture data pre-intervention, during the intervention, and post-intervention	one month

Collaborators and Investigators

• Sponsor: Englewood Hospital and Medical Center
• Collaborators: Nanohealth, Inc.

Study record dates

Study Major Dates

• Study Start (ACTUAL): October 23, 2019
• Primary Completion (ACTUAL): December 23, 2020
• Study Completion (ACTUAL): December 23, 2020

Study Registration Dates

• First Submitted: October 10, 2019
• First Submitted That Met QC Criteria: October 10, 2019
• First Posted (ACTUAL): October 11, 2019

Study Record Updates

• Last Update Posted (ACTUAL): January 5, 2021
• Last Update Submitted That Met QC Criteria: December 30, 2020
• Last Verified: December 1, 2020

More Information

Terms related to this study

• Other Study ID Numbers: E-19-779

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No