NCT04124783

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.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Oct 2019

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 10, 2019

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 11, 2019

Completed
12 days until next milestone

Study Start

First participant enrolled

October 23, 2019

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 23, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 23, 2020

Completed
Last Updated

January 5, 2021

Status Verified

December 1, 2020

Enrollment Period

1.2 years

First QC Date

October 10, 2019

Last Update Submit

December 30, 2020

Conditions

Menopause Symptoms

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (1)

Cooling Bolero

EXPERIMENTAL
Device: Cooling Bolero

Interventions

Cooling BoleroDEVICE

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

Cooling Bolero

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Englewood Health

Englewood, New Jersey, 07631, United States

Location
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 10, 2019

First Posted

October 11, 2019

Study Start

October 23, 2019

Primary Completion

December 23, 2020

Study Completion

December 23, 2020

Last Updated

January 5, 2021

Record last verified: 2020-12

Locations

US(1)