A Double-blind Comparison of Scopolamine With Cinnarizin for Prevention of Simulator Sickness

September 8, 2010 updated by: Medical Corps, Israel Defense Force

A Double-blind Randomized Placebo Controlled Comparison of Scopolamine With Cinnarizin for Prevention of Simulator Sickness

BACKGROUND:flight simulator have become an important component in pilot training. However, they are known to be associated with motion sickness like symptoms defined as Simulator Sickness (SS). Prevention countermeasures against motion sickness have been studied extensively focusing on cholinergic blockers and antihistamines. Most comparataive studies emphasized the effectiveness of scopolamine over outher agents. Evidence, though, on prophylaxis against SS is sparse.

OBJECTIVE: to assess the effectiveness of oral scopolamine versus oral cinnarizine or placebo for SS prevention in helicopter pilots.

DESIGN: a prospective, placebo controlled double-blind.

SETTING: Israel Air Forse (IAF) Helicopter Aircaft vWeapon System Trainer.

PARTICIPANTS: IAF experienced helicopter pilots.

INTERVENTION: 0.6 mg oral scopolamine or 50 mg oral cinnarizine or placebo 1 hour before beginning of a 3 sortie simulator training

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

100

Phase

  • Not Applicable

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

  • Israel
      • Yavne, Israel
        • Recruiting
        • base 30 IAF

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

21 years to 50 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • age 21 to 50 years, qualified helicopter pilots
  • history of average TS score in SSQ more than 7.48

Exclusion Criteria:

  • known vestibular, visual or central nervous system pathology
  • fever of more than 37.2 degrees
  • any MS like symptom prior to simulator training
  • any compromising acute health problem

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

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Finding more effective treatment to the motion sickness symptoms during and after simulator training.
Time Frame: 1 year
To record a significant difference in motion sickness symptoms reduction during and after simulator training, after taking cinnarizine, scopolamine or placebo. We predict that scopolamine will prove to be more effective than cinnarizine with fewer side effects that can compromise pilot's performance during training.
1 year

Collaborators and Investigators

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

Sponsor

Medical Corps, Israel Defense Force

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, 2009

Primary Completion (Anticipated)

September 1, 2010

Study Completion (Anticipated)

September 1, 2010

Study Registration Dates

First Submitted

September 8, 2010

First Submitted That Met QC Criteria

September 8, 2010

First Posted (Estimate)

September 9, 2010

Study Record Updates

Last Update Posted (Estimate)

September 9, 2010

Last Update Submitted That Met QC Criteria

September 8, 2010

Last Verified

September 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 792-2008-IDF-CTIL

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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