Effects of Levocetirizine and Hydroxyzine on Cognitive and Psychomotor Functioning During Simulated Diving
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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Basic Science
|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|
- Number of errors on the cognitive tests [ Time Frame: acute (up to 3.5 hours after treatment administration) ] [ Designated as safety issue: No ]
- Reaction speed on the cognitive tests [ Time Frame: acute (up to 3.5 hours after treatment administration) ] [ Designated as safety issue: No ]
|Study Start Date:||April 2012|
|Study Completion Date:||October 2012|
|Primary Completion Date:||October 2012 (Final data collection date for primary outcome measure)|
|Experimental: Levocetirizine (5 mg)||
a single oral dose of 5 mg
|Active Comparator: Hydroxyzine (50 mg)||
a single oral dose of 50 mg
|Placebo Comparator: Placebo||
a single oral dose
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01496911
|Royal Netherlands Navy|
|Den Helder, Noord Holland, Netherlands, 1780CA|
|Principal Investigator:||Joris Verster, PhD||Utrecht University|