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
Description:
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.
Condition:
Healthy Volunteers
Treatment:
Levocetirizine
Start Date:
April 2012
Sponsor:
Utrecht Institute for Pharmaceutical Sciences
For More Information:
https://clinicaltrials.gov/show/NCT01496911