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

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ClinicalTrials.gov Identifier: NCT04124783
Recruitment Status : Not yet recruiting
First Posted : October 11, 2019
Last Update Posted : October 11, 2019
Sponsor:
Collaborator:
Nanohealth, Inc.
Information provided by (Responsible Party):
Englewood Hospital and Medical Center

Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Menopause Symptoms Device: Cooling Bolero Not Applicable

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


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Pilot Study to Evaluate the Effects of the Nanoheath, Inc. Cooling Bolero in Women With Common Menopause Symptoms
Estimated Study Start Date : October 2019
Estimated Primary Completion Date : October 2020
Estimated Study Completion Date : October 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Menopause

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




Primary Outcome Measures :
  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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04124783


Contacts
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Contact: David Abramson, MD (201) 568-6977 david.abramson@ehmchealth.org
Contact: Jamie Ketas 201-894-3418 jamie.ketas@ehmchealth.org

Sponsors and Collaborators
Englewood Hospital and Medical Center
Nanohealth, Inc.

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Responsible Party: Englewood Hospital and Medical Center
ClinicalTrials.gov Identifier: NCT04124783     History of Changes
Other Study ID Numbers: E-19-779
First Posted: October 11, 2019    Key Record Dates
Last Update Posted: October 11, 2019
Last Verified: October 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No