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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Menopause Symptoms

Intervention / Treatment
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* Device: Cooling Bolero


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cooling Bolero<br>All participants will use the Cooling Bolero for one month | Device: Cooling Bolero<br>* a vest filled with a new material (not ice or a gel) that provides controlled cooling by absorbing heat<br>|

What is the study measuring?
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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 |