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Sea sickness represents a major limitation on the performance of ships' crew. One of the challenges faced by the physician in the motion sickness clinic when prescribing anti-sea sickness medication is to select the appropriate drug for the patient. Difficulties arise due to high variability in the response to different drugs. In the case of sea sickness, the current procedure is to examine the drug's efficacy in each individual during real time exposure to sea conditions.
A number of studies have documented the presence of sea sickness drug receptors in the vestibular nuclei, which determine the vestibular time constant. Two clinical vestibular tests which evaluate the time constant are the Velocity Step and OKAN tests. The purpose of the proposed study is to evaluate the influence of motion sickness drugs on the vestibular time constant, as a possible bioequivalent of drug potency in the individual subject. Eighty crew members will be recruited and divided into groups responsive and non-responsive to the sea sickness drugs scopolamine and meclizine.
Subjects having a Wiker score of 7 in waves 1 meter high without drug treatment, and no improvement in symptoms after treatment will be defined as non-responsive to sea sickness drugs. Subjects having a Wiker score of 7 in waves 1 meter high without drug treatment, and a Wiker score of 4 or less after treatment, will be defined as responsive to drug therapy.
Kwells, Bonine and placebo, will be assigned to each subject in a random, double-blind fashion. Each group will perform the Velocity Step and OKAN tests before, one and two hours after drug or placebo administration.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Responsive to Scopolamine (Active) | Active Comparator | Scopolamine administration - subject will take 1 tablet per os (Kwells, Hyoscine Hydrobromide 0.3mg, 1*day ) |
|
| Responsive to Scopolamine (Placebo) | Placebo Comparator | Placebo administration - subject will take 1 tablet per os (Placebo Oral Tablet, no active substance in the tablet) |
|
| Non-responsive to Scopolamine (Active) | Active Comparator | Scopolamine administration - subject will take 1 tablet per os (Kwells, Hyoscine Hydrobromide 0.3mg, 1*day ) |
|
| Non-responsive to Scopolamine (Placebo) | Placebo Comparator | Placebo administration - subject will take 1 tablet per os (Placebo Oral Tablet, no active substance in the tablet) |
|
| Responsive to Meclizine (Active) | Active Comparator | Meclizine administration - subject will take 1 tablet per os (Bonine 25Mg Chewable Tablet, Meclizine Hydrochloride 25mg, 1*day ) |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bonine 25Mg Chewable Tablet | Drug | Motion sickness drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| Vestibular Time Constant Change/differential | One of the parameters measured in step velocity test [Sec] | Baseline at the beginning of session prior to comparator (drug/placebo) receiving, 1 hour after receiving comparator and 2 hours after receiving comparator. |
| Step Velocity Test Gain Change/differential | One of the parameters measured in step velocity test [0-1] | Baseline at the beginning of session prior to comparator (drug/placebo) receiving, 1 hour after receiving comparator and 2 hours after receiving comparator. |
| Optokinetic After Nystagmus (OKAN) Gain Change/differential | One of the parameters measured in optokinetic test [0-1] | Baseline at the beginning of session prior to comparator (drug/placebo) receiving, 1 hour after receiving comparator and 2 hours after receiving comparator. |
| Optokinetic After Nystagmus (OKAN) Time Constant Change/differential | One of the parameters measured in optokinetic test [Sec] | Baseline at the beginning of session prior to comparator (drug/placebo) receiving, 1 hour after receiving comparator and 2 hours after receiving comparator. |
| Optokinetic After Nystagmus (OKAN) Slow Phase velocity Sum Change/differential | One of the parameters measured in optokinetic test [Deg/Sec] | Baseline at the beginning of session prior to comparator (drug/placebo) receiving, 1 hour after receiving comparator and 2 hours after receiving comparator. |
| Pupil Size Change/differential | Using pupil size chart [Mm] |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Dror Tal, PhD | Head of Motion Sickness and Human Performance Laboratory, Principal Investigator | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Israeli Navy Medical Institute | Haifa | Israel |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 1859339 | Background | Cheung BS, Howard IP, Money KE. Visually-induced sickness in normal and bilaterally labyrinthine-defective subjects. Aviat Space Environ Med. 1991 Jun;62(6):527-31. | |
| 21287155 | Background | Dai M, Raphan T, Cohen B. Prolonged reduction of motion sickness sensitivity by visual-vestibular interaction. Exp Brain Res. 2011 May;210(3-4):503-13. doi: 10.1007/s00221-011-2548-8. Epub 2011 Feb 2. |
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| ID | Term |
|---|---|
| D064420 | Drug-Related Side Effects and Adverse Reactions |
| ID | Term |
|---|---|
| D064419 | Chemically-Induced Disorders |
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| ID | Term |
|---|---|
| D008468 | Meclizine |
| D012601 | Scopolamine |
| ID | Term |
|---|---|
| D001559 | Benzhydryl Compounds |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
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| Responsive to Meclizine (Placebo) | Placebo Comparator | Placebo administration - subject will take 1 tablet per os (Placebo Oral Tablet, no active substance in the tablet) |
|
| Non-responsive to Meclizine (Active) | Active Comparator | Meclizine administration - subject will take 1 tablet per os (Bonine 25Mg Chewable Tablet, Meclizine Hydrochloride 25mg, 1*day ) |
|
| Non-responsive to Meclizine (Placebo) | Placebo Comparator | Placebo administration - subject will take 1 tablet per os (Placebo Oral Tablet, no active substance in the tablet) |
|
| Kwells | Drug | Motion sickness drug |
|
|
| Placebo Oral Tablet | Drug | No active substance in the tablet |
|
|
| Baseline at the beginning of session prior to comparator (drug/placebo) receiving, 1 hour after receiving comparator and 2 hours after receiving comparator. |
| Pupil Accommodation and Convergation Change/differential | Eye test for drugs side effects. | Baseline at the beginning of session prior to comparator (drug/placebo) receiving, 1 hour after receiving comparator and 2 hours after receiving comparator. |
| Side Effects Questionnaire Change/differential | Questionnaire of drugs' side effects. | Baseline at the beginning of session prior to comparator (drug/placebo) receiving, 1 hour after receiving comparator and 2 hours after receiving comparator. |
| 25502048 | Background | Golding JF, Gresty MA. Pathophysiology and treatment of motion sickness. Curr Opin Neurol. 2015 Feb;28(1):83-8. doi: 10.1097/WCO.0000000000000163. |
| 9303164 | Background | Ishiyama A, Lopez I, Wackym PA. Molecular characterization of muscarinic receptors in the human vestibular periphery. Implications for pharmacotherapy. Am J Otol. 1997 Sep;18(5):648-54. |
| 2139500 | Background | Phelan KD, Nakamura J, Gallagher JP. Histamine depolarizes rat medial vestibular nucleus neurons recorded intracellularly in vitro. Neurosci Lett. 1990 Feb 16;109(3):287-92. doi: 10.1016/0304-3940(90)90009-x. |
| 4024910 | Background | Pyykko I, Schalen L, Matsuoka I. Transdermally administered scopolamine vs. dimenhydrinate. II. Effect on different types of nystagmus. Acta Otolaryngol. 1985 May-Jun;99(5-6):597-604. doi: 10.3109/00016488509182266. |
| 17726280 | Background | Tal D, Hershkovitz D, Kaminski G, Bar R. Vestibular evoked myogenic potential threshold and seasickness susceptibility. J Vestib Res. 2006;16(6):273-8. |
| 19698013 | Background | Bar R, Gil A, Tal D. Safety of double-dose transdermal scopolamine. Pharmacotherapy. 2009 Sep;29(9):1082-8. doi: 10.1592/phco.29.9.1082. |
| D006838 |
| Hydrocarbons |
| D009930 | Organic Chemicals |
| D010879 | Piperazines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D012602 | Scopolamine Derivatives |
| D014326 | Tropanes |
| D053961 | Azabicyclo Compounds |
| D001372 | Aza Compounds |
| D001533 | Belladonna Alkaloids |
| D012991 | Solanaceous Alkaloids |
| D000470 | Alkaloids |
| D019086 | Bridged Bicyclo Compounds, Heterocyclic |
| D006572 | Heterocyclic Compounds, Bridged-Ring |