A Double-blind Comparison of Scopolamine With Cinnarizin for Prevention of Simulator Sickness
A Double-blind Randomized Placebo Controlled Comparison of Scopolamine With Cinnarizin for Prevention of Simulator Sickness
1 other identifier
interventional
100
1 country
1
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Sep 2009
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2010
CompletedFirst Submitted
Initial submission to the registry
September 8, 2010
CompletedFirst Posted
Study publicly available on registry
September 9, 2010
CompletedSeptember 9, 2010
September 1, 2010
1 year
September 8, 2010
September 8, 2010
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Finding more effective treatment to the motion sickness symptoms during and after simulator training.
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
Interventions
Eligibility Criteria
You may qualify if:
- age 21 to 50 years, qualified helicopter pilots
- history of average TS score in SSQ more than 7.48
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
base 30 IAF
Yavné, Israel
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- PREVENTION
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
September 8, 2010
First Posted
September 9, 2010
Study Start
September 1, 2009
Primary Completion
September 1, 2010
Study Completion
September 1, 2010
Last Updated
September 9, 2010
Record last verified: 2010-09