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

• Sponsor: Medical Corps, Israel Defense Force (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT01198106
• Collaborator: (none)
• Enrollment: 100
• Location: 1
• Duration (Months): 12
• Patients Per Site Per Month: 8.3

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Simulator Sickness	Drug: scopolamine; Drug: cinnarizine	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 100 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: Single (Participant)
• Primary Purpose: Prevention
• Official Title: A Double-blind Randomized Placebo Controlled Comparison of Scopolamine With Cinnarizin for Prevention of Simulator Sickness
• Study Start Date: Sep 1, 2009
• Anticipated Primary Completion Date: Sep 1, 2010
• Anticipated Study Completion Date: Sep 1, 2010

Outcome Measures

Primary Outcome Measures

1. 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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 21 Years to 50 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	base 30 IAF	Yavne		Israel

Sponsors and Collaborators

• Medical Corps, Israel Defense Force

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT01198106
• Other Study ID Numbers: 792-2008-IDF-CTIL
• First Posted: Sep 9, 2010
• Last Update Posted: Sep 9, 2010
• Last Verified: Sep 1, 2010

• Keywords provided by , ,: simulator sickness; scopolamine; cinnarizine
• Additional relevant MeSH terms: Cinnarizine; Scopolamine; Butylscopolammonium Bromide

Study Results

No Results Posted as of Sep 9, 2010