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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-09-30

Study Completion Date

2010-09-30

Brief Summary

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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

Detailed Description

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Conditions

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Simulator Sickness

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Participants

Interventions

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scopolamine

0.6 mg

Intervention Type DRUG

cinnarizine

50 mg

Intervention Type DRUG

Other Intervention Names

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kwells stonoron

Eligibility Criteria

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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

Minimum Eligible Age

21 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Responsible Party

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IAF aeromedical center

Locations

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base 30 IAF

Yavné, , Israel

Site Status RECRUITING

Countries

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Israel

Central Contacts

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Amit Assa, Dr.

Role: CONTACT

03-7379142

Other Identifiers

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792-2008-IDF-CTIL

Identifier Type: -

Identifier Source: org_study_id