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

Simulator Sickness Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01198106
• Other study ID #: 792-2008-IDF-CTIL
• Status: Recruiting
• Phase: N/A
• First received: September 8, 2010
• Last updated: September 8, 2010
• Start date: September 2009
• Est. completion date: September 2010

Study information

• Verified date: September 2010
• Source: Medical Corps, Israel Defense Force
• Contact: Amit Assa, Dr.
• Phone: 03-7379142
• Is FDA regulated: No
• Health authority: Israel: Israeli Health Ministry Pharmaceutical Administration
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: September 2010
• Est. primary completion date: September 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 21 Years to 50 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Single Blind (Subject), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Simulator Sickness

Intervention

Drug:
• scopolamine
0.6 mg
• cinnarizine
50 mg

Locations

Country	Name	City	State
Israel	base 30 IAF	Yavne

Sponsors (1)

Lead Sponsor	Collaborator
Medical Corps, Israel Defense Force

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes