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

Not Applicable

• Conditions: Simulator Sickness

• Registration Number: NCT01198106
• Lead Sponsor: Medical Corps, Israel Defense Force

Brief Summary

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

Not available

Study Timeline

• Study Start: 2009-09
• Status Verified: 2010-09
• Primary Completion: 2010-09
• Study Completion: 2010-09
• Study First Submitted: 2010-09-08
• Study First Submitted QC: 2010-09-08
• Last Update Submitted: 2010-09-08
• Study First Posted: 2010-09-09
• Last Update Posted: 2010-09-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
Finding more effective treatment to the motion sickness symptoms during and after simulator training.	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.

Trial Locations

Locations (1)

base 30 IAF; 🇮🇱 Yavne, Israel