Healthy Volunteers Clinical Trial
Official title:
Study to Investigate the Effects of Levocetirizine and Hydroxyzine on Cognitive and Psychomotor Functioning During Simulated Diving at 2 Bar and 4 Bar in Professional Navy Divers
Antihistamines are commonly used and currently levocetirizine is most frequently prescribed in the Netherlands. They are commonly used by divers, to solve ear, nose and throat problems, especially to open tubal passage. However, the effects of these drugs on cognitive performance have not been investigated during diving.The objective of this study is to investigate the effects of levocetirizine, hydroxyzine and placebo on cognitive and psychomotor functioning during controlled simulated diving in a hyperbaric chamber in professional navy divers at 10 mt (2 bar) and 30 mt (4 bar).It is hypothesized that hydroxyzine will produce significant impairment, and that the magnitude of impairment is related to hyperbaric pressure.
This double-blind, randomized, placebo-controlled cross-over study will comprise of 1
training day and 3 test days. Twenty-four healthy male divers from the Royal Netherlands
Navy will participate in this study.The objective of this study is to investigate the single
dose effects of levocetirizine (5 mg), hydroxyzine (50 mg) and placebo.
Visit 1 is a training day, and Visit 2-4 are test days. At the test day, subjects receive
one of the three medications. One hour after administration of the drugs, subjects will
start with the dive in the recompression chamber. After one hour, medication has reached
their peak plasma concentration, and effects can be expected. There will be a wash-out
period of at least 7 days between the test days.
Subjects will perform one simulated dive at each test day. They first descend in 2 min to a
pressure of 4 bar (30 mt), stay for 20 min, the dive continues when they ascend to a
pressure of 2 bar (10 mt) with another stay for 20 min. At both depths the 20 min periods
are the measuring period to perform the test. At the end they will go to the surface
according the decompression profile and stop for 3 min at 9 mt, 8 min at 6 mt and 23 min at
3 mt. These decompression stops are regular for the profile and necessary to prevent
decompression sickness.Before and after diving, and at 2 and 4 bar, tests measuring
attention, memory, psychomotor, concentration and comprehension ability of the participants
are conducted.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Basic Science
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