Investigate the effects of levocetirizine, diphenhydramine and placebo on cognitive and psychomotor functioning during controlled simulated diving in a recompression chamber in professional navy divers at 10 mt (2 bar) and 30 mt (4 bar).
ID
Source
Brief title
Condition
- Other condition
Synonym
Health condition
Allergische rhinitis
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Reaction time.
Secondary outcome
The percentage of errors on the tests.
Background summary
Divers may use psychoactive medication. The effects of these drugs on cognitive
performance have not been investigated during diving.
Study objective
Investigate the effects of levocetirizine, diphenhydramine and placebo on
cognitive and psychomotor functioning during controlled simulated diving in a
recompression chamber in professional navy divers at 10 mt (2 bar) and 30 mt (4
bar).
Study design
A double-blind, placebo-controlled crossover study.
Intervention
Each subject performs 3 test days: levocetirizine (5 mg), diphenhydramine (50
mg) and placebo.
Study burden and risks
The dive profile/procedure has the approval of the Surgeon General and the
Super Intendant of Diving of the Royal Netherlands Navy. The dive test is
within the normal safety limits and is not an exceptional exposure according
the RNLN Diving Manual. The dive profile fits within the regular training
capabilities of the participants.
The risks are minimal, because tests are performed in a diving simulator
supervised by medical and technical personnel. Subjects are professional Navy
divers. Dives are not known to produce serious adverse events. Adverse events
usually disappear within a couple of hours after intake of the drugs. There are
no specific benefits for participants, besides gaining insight in their own
diving performance. Military divers will receive reimbursements for the diving
according Navy regulations based on depth/time profile.
PoBox 80082
3508 TB Utrecht
Nederland
PoBox 80082
3508 TB Utrecht
Nederland
Listed location countries
Age
Inclusion criteria
Man
He is aged between 18 and 55 years old
BMI between 18 and 30
Written informed consent
Normal static binocular acuity, corrected or uncorrected
Normal hearing
Possession of a valid divers certificate and medical fit for diving
Be considered as reliable and mentally capable of adhering to the protocol.
Exclusion criteria
Current drug use (questionnaire at the start of the test day)
Use of psychoactive medication
Prior enrolment in the same study
Physical or mental illness
Excessive alcohol use (>21 alcoholic drinks per week)
Intake of caffeine-containing beverages over 5 glasses per day
Smoker
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 | EUCTR2010-019147-19-NL |
| CCMO | NL31760.041.10 |