To assess the effect of betahistine on the severity / intensity of motion sickness
ID
Source
Brief title
Condition
- Other condition
- Aural disorders NEC
Synonym
Health condition
bewegingsziekte
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
It is expected that betahistine will diminish motion sickness. In both
conditions of the experiment subjects will be exposed to the same motion
stimulus. This stimulus will last for half an hour, or less if a certain motion
sickness level (**moderate nausea**), indicated by the subject, is reached
prior to the end of the 30 min period. The exposure duration is the main study
parameter.
The tests at the screening have a dual goal: to determine the
participants*motion sickness susceptibility level, and to determine which
motion stimulus is provocative enough to induce motion sickness within 30
minutes, but not within a few minutes. For this test, a motion sickness
inducing stimulus will be chosen that does not invoke hyperventilation. To this
effect the breathing of the subjects is analysed during the tests so that
hyperventilation can be excluded.
Secondary outcome
n.a.
Background summary
Conventional motion sickness medication has the side effect of sleepiness. For
travellers that have to fulfil certain tasks or responsibilities aboard a car,
plane or ship (or other moving entity), such side effects are not desirable.
This prompts the need for motion sickness medication that is suitable for
professionals such as crew members, pilots or sailors.
This study will evaluate the impact of betahistine on motion sickness. It is
anticipated that intake of betahistine will diminish feelings of motion
sickness in comparison with placebo.
Study objective
To assess the effect of betahistine on the severity / intensity of motion
sickness
Study design
The study is designed as a randomized, cross-over, placebo-controlled,
double-blind study. The study will be conducted during a three-week period in
which 26 volunteers will be subjected to two conditions. They will visit TNO
three times. Once for a screening and twice more for the actual experiment.
Before each test session, subjects will have taken placebo or betahistine
during one week. The study will be conducted in the test device Desdemona.
Intervention
All subjects will receive the following study treatment: The first week
subjects take 48 mg betahistine three times daily (3x48 mg) or a placebo three
times daily. The second week they take the opposite of what they took the week
before (3x48 mg betahistine or 3xplacebo)
Study burden and risks
Before the study, subjects will be screened, based on their medical history and
they will undergo a physical examination to ascertain their health. Also they
will be tested in the Desdemona facility to establish their susceptibility for
motion sickness
After the intake, the subjects will visit TNO two times. Each time they may
reach the moderate nausea level, which in all conditions is also an endpoint.
The after-effects of motion sickness are short-lasting.
Postbus 23
3769 ZG Soesterberg
Nederland
Postbus 23
3769 ZG Soesterberg
Nederland
Listed location countries
Age
Inclusion criteria
Female volunteers should take oral contraceptives (combined or progestogen only). Body Mass Index (BMI) 18-28 kg/m2
Healthy as assessed by health questionnaire (Pbetahistine F02; in Dutch) and a physical examination limited to auscultation of heart and lung, blood pressure and heart rate
Susceptibility to motion sickness is more than 35 on Golding*s MSSQ scale.
Exclusion criteria
Participation in any clinical trial including blood sampling and/or administration of substances up to 30 days before Day 01 of this study
Having a history of medical or surgical events that may significantly affect the study outcome
Clinically relevant medical problems (vestibular, cardiovascular, pulmonary, gastrointestinal, neurological, psychiatric, hepatic, renal, hematological or other organic abnormality or pathology, including: asthma, ulcus pepticum urticaria, or allergic complaints as a rash or allergic rhinitis).
Participation in any non-invasive clinical trial up to 30 days before Day 01 of this study
Subjects who are mentally handicapped.
Subjects who have taken (non)prescription medications within the last 14 days, with the exception of painkillers such as aspirin, paracetamol, ibuprofen, up to 72 hours prior to the start of the study.
Inclination to hyperventilation (Nijmegen questionnaire score > 23)
Not able to undergo the familiarization tests inside the moving base-simulator Desdemona
Alcohol consumption females > 21 or units/week; males >28 units/week
Pregnancy or breastfeeding
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| EudraCT | EUCTR2008-000885-21-NL |
| CCMO | NL22006.028.08 |