NCT02795741

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
15

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jul 2016

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

June 2, 2016

Completed
8 days until next milestone

First Posted

Study publicly available on registry

June 10, 2016

Completed
21 days until next milestone

Study Start

First participant enrolled

July 1, 2016

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2018

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2018

Completed
Last Updated

June 14, 2018

Status Verified

June 1, 2018

Enrollment Period

1.7 years

First QC Date

June 2, 2016

Last Update Submit

June 13, 2018

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

All participants will use the Cooling Bolero for one month

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:

  • Has another existing medical condition that would prevent study compliance.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Englewood Hospital and Medical Center

Englewood, New Jersey, 07631, United States

Location

Related Links

Study Officials

  • David Abramson, MD

    Englewood Hospital and Medical Center

    PRINCIPAL INVESTIGATOR

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

June 2, 2016

First Posted

June 10, 2016

Study Start

July 1, 2016

Primary Completion

March 1, 2018

Study Completion

May 1, 2018

Last Updated

June 14, 2018

Record last verified: 2018-06

Data Sharing

IPD Sharing
Will not share

Locations

US(1)