Simulator SicknessNCT01198106
A Double-blind Comparison of Scopolamine With Cinnarizin for Prevention of Simulator Sickness
A study testing scopolamine and cinnarizine in people with Simulator Sickness, run by Medical Corps, Israel Defense Force at 1 site in Israel.
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). Read more about this study
- Who is it for?
- Ages 21 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Simulator Sickness
- What is being tested?
- scopolamine and cinnarizine
- How many people
- 100 participants
- Where
- 1 siteIsrael
- Study dates
- Sep 2009to Sep 2010
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- age 21 to 50 years, qualified helicopter pilots
- history of average TS score in SSQ more than 7.48
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Amit Assa, Dr. contact
About this study
Official title: A Double-blind Randomized Placebo Controlled Comparison of Scopolamine With Cinnarizin for Prevention of Simulator Sickness
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.
Read more
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
- Conditions
- Simulator Sickness
- Being tested
- scopolamine, cinnarizine
- Keywords
- simulator sickness, scopolamine, cinnarizine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
scopolamineDrug
Also called kwells
0.6 mg
cinnarizineDrug
Also called stonoron
50 mg
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2010 (estimated)
- Study startSep 2009
- Primary completionSep 2010 (estimated)
- Study completionSep 2010 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Simulator SicknessStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical Corps, Israel Defense Force
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01198106
- Sponsor's protocol ID
- 792-2008-IDF-CTIL
- Status last verified
- Sep 2010
- First submitted
- 8 Sep 2010
- Last updated
- 9 Sep 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-blind Randomized Placebo Controlled Comparison of Scopolamine With Cinnarizin for Prevention of Simulator Sickness
- ClinicalTrials.gov ID
- NCT01198106
- Acronym / sponsor ID
- 792-2008-IDF-CTIL
- Conditions
- Simulator Sickness
- Keywords
- simulator sickness, scopolamine, cinnarizine
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Medical Corps, Israel Defense ForceUniversity, hospital or other
- Study start
- Sep 2009
- Primary completion
- Sep 2010 (estimated)
- Study completion
- Sep 2010 (estimated)
- First posted
- 9 Sep 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
Who may qualify
- Ages
- 21 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- age 21 to 50 years, qualified helicopter pilots
- history of average TS score in SSQ more than 7.48
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| scopolamineAlso: kwells0.6 mg | Drug | – |
| cinnarizineAlso: stonoron50 mg | Drug | – |
Primary outcome
Finding more effective treatment to the motion sickness symptoms during and after simulator training.
Time frame: 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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2010.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Amit Assa, Dr. contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing scopolamine and cinnarizine in people with Simulator Sickness, run by Medical Corps, Israel Defense Force at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 Sep 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Amit Assa, Dr. (03-7379142), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Finding more effective treatment to the motion sickness symptoms during and after simulator training. (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Sep 2010.