Motion Sickness Medications and Vestibular Time Constant

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Statusas

Rėmėjai

Medical Corps, Israel Defense Force

KLINIKINIS TYRIMAS: NCT03270839

BioSeek: nct03270839

Raktažodžiai

skopolaminas

Santrauka

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.

Datos

Paskutinį kartą patikrinta:	07/31/2017
Pirmasis pateikimas:	04/01/2017
Numatytas registravimas pateiktas:	08/30/2017
Pirmas paskelbtas:	08/31/2017
Paskutinis atnaujinimas pateiktas:	08/30/2017
Paskutinis atnaujinimas paskelbtas:	08/31/2017
Faktinė studijų pradžios data:	05/31/2017
Numatoma pirminio užbaigimo data:	02/28/2018
Numatoma studijų užbaigimo data:	04/30/2018

Būklė ar liga

Drug Reaction

Intervencija / gydymas

Drug: Bonine 25Mg Chewable Tablet

Drug: Kwells

Drug: Placebo Oral Tablet

Fazė

Fazė 4

Rankų grupės

Ranka	Intervencija / gydymas
Active Comparator: Responsive to Scopolamine (Active) Scopolamine administration - subject will take 1 tablet per os (Kwells, Hyoscine Hydrobromide 0.3mg, 1*day )
Placebo Comparator: Responsive to Scopolamine (Placebo) Placebo administration - subject will take 1 tablet per os (Placebo Oral Tablet, no active substance in the tablet)
Active Comparator: Non-responsive to Scopolamine (Active) Scopolamine administration - subject will take 1 tablet per os (Kwells, Hyoscine Hydrobromide 0.3mg, 1*day )
Placebo Comparator: Non-responsive to Scopolamine (Placebo) Placebo administration - subject will take 1 tablet per os (Placebo Oral Tablet, no active substance in the tablet)
Active Comparator: Responsive to Meclizine (Active) Meclizine administration - subject will take 1 tablet per os (Bonine 25Mg Chewable Tablet, Meclizine Hydrochloride 25mg, 1*day )
Placebo Comparator: Responsive to Meclizine (Placebo) Placebo administration - subject will take 1 tablet per os (Placebo Oral Tablet, no active substance in the tablet)
Active Comparator: Non-responsive to Meclizine (Active) Meclizine administration - subject will take 1 tablet per os (Bonine 25Mg Chewable Tablet, Meclizine Hydrochloride 25mg, 1*day )
Placebo Comparator: Non-responsive to Meclizine (Placebo) Placebo administration - subject will take 1 tablet per os (Placebo Oral Tablet, no active substance in the tablet)

Tinkamumo kriterijai

Amžius, tinkami studijuoti	18 Years Į 18 Years
Tinkamos studijoms lytys	Male
Priima sveikus savanorius	Taip
Kriterijai	Inclusion Criteria: - Healthy soldiers between the ages of 18 to 40, who suffering from sea sickness - 48 hours prior to session without any use of medications - Soldiers who vomit in waves 1.5 meter high without drugs treatment Exclusion Criteria: - Anamnestic hearing Impairment - Ear infection of any kind - Pathological finding in an otoneurological examination, witch will be done by a trained neurophysiologist / a physician. In any case of pathological finding, patient will be advised to continue medical assesment. - Vision pathologies the interfere with VNG test. - Withdrawal of informed consent by the patient of any cause.

Rezultatas

Pirminės rezultatų priemonės

1. Vestibular Time Constant Change/differential [Baseline at the beginning of session prior to comparator (drug/placebo) receiving, 1 hour after receiving comparator and 2 hours after receiving comparator.]

One of the parameters measured in step velocity test [Sec]

2. Step Velocity Test Gain Change/differential [Baseline at the beginning of session prior to comparator (drug/placebo) receiving, 1 hour after receiving comparator and 2 hours after receiving comparator.]

One of the parameters measured in step velocity test [0-1]

3. Optokinetic After Nystagmus (OKAN) Gain Change/differential [Baseline at the beginning of session prior to comparator (drug/placebo) receiving, 1 hour after receiving comparator and 2 hours after receiving comparator.]

One of the parameters measured in optokinetic test [0-1]

4. Optokinetic After Nystagmus (OKAN) Time Constant Change/differential [Baseline at the beginning of session prior to comparator (drug/placebo) receiving, 1 hour after receiving comparator and 2 hours after receiving comparator.]

One of the parameters measured in optokinetic test [Sec]

5. Optokinetic After Nystagmus (OKAN) Slow Phase velocity Sum Change/differential [Baseline at the beginning of session prior to comparator (drug/placebo) receiving, 1 hour after receiving comparator and 2 hours after receiving comparator.]

One of the parameters measured in optokinetic test [Deg/Sec]

6. Pupil Size Change/differential [Baseline at the beginning of session prior to comparator (drug/placebo) receiving, 1 hour after receiving comparator and 2 hours after receiving comparator.]

Using pupil size chart [Mm]

7. Pupil Accommodation and Convergation Change/differential [Baseline at the beginning of session prior to comparator (drug/placebo) receiving, 1 hour after receiving comparator and 2 hours after receiving comparator.]

Eye test for drugs side effects.

8. Side Effects Questionnaire Change/differential [Baseline at the beginning of session prior to comparator (drug/placebo) receiving, 1 hour after receiving comparator and 2 hours after receiving comparator.]

Questionnaire of drugs' side effects.