Effect of Systemic Cooling in Vasospasms

September 25, 2008 updated by: University Hospital, Basel, Switzerland

Effect of Systemic Cooling in Vasospasms (Kühleffekte Beim Vasospastischen Syndrom)

This study tests whether women with Vasospastic Syndrome (VS) react more intensive than controls with distal vasomotions and choroidal blood flow changes to internal cooling/warming and external cooling/warming.

Study Overview

Status

Completed

Conditions

Detailed Description

Distal vasomotions and choroidal blood flow changes to internal cooling/warming and external cooling/warming was studied in VS and controls.Core cooling was induced by drinking of 250g ice/water mixture (4°C). Core warming was induced by drinking of 250g warm water (55°C). The study was controlled with respect to posture and room temperature.

Study Type

Observational

Enrollment (Actual)

28

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Switzerland
      • Basel, Switzerland, 4056
        • University Eye Clinic

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years to 35 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

vasospastic women

Description

Inclusion Criteria:

  • women
  • luteal phase or contraceptives
  • 19-35 years

Exclusion Criteria:

  • somatic diseases
  • psychiatric diseases
  • BMI > 25
  • BMI < 18

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
LDF blood flow
Time Frame: repeated after each challenge
repeated after each challenge
LDF velocity
Time Frame: repeated after each challenge
repeated after each challenge
finger skin temperature
Time Frame: repeated after each challenge
repeated after each challenge
core body temperature
Time Frame: repeated after each challenge
repeated after each challenge
corneal temperature
Time Frame: repeated after each challenge
repeated after each challenge

Secondary Outcome Measures

Outcome Measure
Time Frame
subjective sleepiness
Time Frame: repeated after each challenge
repeated after each challenge
subjective ratings of thermal comfort
Time Frame: repeated after each challenge
repeated after each challenge

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Basel, Switzerland

Investigators

  • Study Director: Selim Orguel, MD, Unversity Eye Clinic Basel

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2004

Primary Completion (Actual)

May 1, 2006

Study Completion (Actual)

June 1, 2006

Study Registration Dates

First Submitted

December 7, 2006

First Submitted That Met QC Criteria

December 7, 2006

First Posted (Estimate)

December 8, 2006

Study Record Updates

Last Update Posted (Estimate)

September 26, 2008

Last Update Submitted That Met QC Criteria

September 25, 2008

Last Verified

September 1, 2008

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 007-KRK-2004-001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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