Study to Evaluate the Effects of the Cooling Bolero in Women With Common Menopause Symptoms
NCT ID: NCT02795741
Last Updated: 2018-06-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
15 participants
INTERVENTIONAL
2016-07-31
2018-05-31
Brief Summary
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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.
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Detailed Description
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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.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Cooling Bolero
All participants will use the Cooling Bolero for one month
Cooling Bolero
a vest filled with a new material (not ice or a gel) that provides controlled cooling by absorbing heat
Interventions
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Cooling Bolero
a vest filled with a new material (not ice or a gel) that provides controlled cooling by absorbing heat
Eligibility Criteria
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Inclusion Criteria
* Self-reports having at least two (2) daily hot flashes associated with menopause.
Exclusion Criteria
18 Years
FEMALE
No
Sponsors
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Nanohealth, Inc.
INDUSTRY
Englewood Hospital and Medical Center
OTHER
Responsible Party
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Principal Investigators
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David Abramson, MD
Role: PRINCIPAL_INVESTIGATOR
Englewood Hospital and Medical Center
Locations
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Englewood Hospital and Medical Center
Englewood, New Jersey, United States
Countries
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Related Links
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Related Info
Other Identifiers
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E-16-661
Identifier Type: -
Identifier Source: org_study_id
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