NCT02226614

Brief Summary

This study is testing a head-cooling device on volunteers to assess temperature reduction.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2014

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

July 22, 2014

Completed
10 days until next milestone

Study Start

First participant enrolled

August 1, 2014

Completed
26 days until next milestone

First Posted

Study publicly available on registry

August 27, 2014

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2016

Completed
Last Updated

June 15, 2016

Status Verified

December 1, 2015

Enrollment Period

1.5 years

First QC Date

July 22, 2014

Last Update Submit

June 14, 2016

Conditions

Body Temperature Changes

Outcome Measures

Primary Outcomes (1)

  • Temperature change

    6 hours

Study Arms (1)

head cooling

EXPERIMENTAL

head cooling

Device: University of Edinburgh head cooling device

Interventions

University of Edinburgh head cooling deviceDEVICE

head cooling

head cooling

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • healthy humans

You may not qualify if:

  • pregnant
  • refusal of consent for registration with The Over-volunteering Protection Scheme

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Western General Hospital

Edinburgh, EH4 2XU, United Kingdom

Location

MeSH Terms

Conditions

Body Temperature Changes

Condition Hierarchy (Ancestors)

Signs and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Peter Andrews, MD

    University of Edinburgh

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

July 22, 2014

First Posted

August 27, 2014

Study Start

August 1, 2014

Primary Completion

February 1, 2016

Study Completion

February 1, 2016

Last Updated

June 15, 2016

Record last verified: 2015-12

Locations

GB(1)