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Effects of Levocetirizine and Hydroxyzine on Cognitive and Psychomotor Functioning During Simulated Diving

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ClinicalTrials.gov Identifier: NCT01496911
Recruitment Status : Completed
First Posted : December 21, 2011
Last Update Posted : November 6, 2013
Information provided by (Responsible Party):

Study Description
Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Healthy Volunteers Drug: Levocetirizine Drug: Hydroxyzine Drug: Placebo Phase 4

Detailed 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.

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, 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
Study Start Date : April 2012
Primary Completion Date : October 2012
Study Completion Date : October 2012

Arms and Interventions

Arm Intervention/treatment
Experimental: Levocetirizine (5 mg) Drug: Levocetirizine
a single oral dose of 5 mg
Active Comparator: Hydroxyzine (50 mg) Drug: Hydroxyzine
a single oral dose of 50 mg
Placebo Comparator: Placebo Drug: Placebo
a single oral dose

Outcome Measures

Primary Outcome Measures :
  1. Number of errors on the cognitive tests [ Time Frame: acute (up to 3.5 hours after treatment administration) ]

Secondary Outcome Measures :
  1. Reaction speed on the cognitive tests [ Time Frame: acute (up to 3.5 hours after treatment administration) ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • male healthy volunteer
  • 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:

  • Female
  • Current drug use
  • Use of psychoactive medication, including antihistamines
  • 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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01496911

Royal Netherlands Navy
Den Helder, Noord Holland, Netherlands, 1780CA
Sponsors and Collaborators
Utrecht Institute for Pharmaceutical Sciences
Royal Netherlands Navy
Principal Investigator: Joris Verster, PhD Utrecht University
More Information

Responsible Party: Dr Joris C Verster, Assistant professor, Utrecht Institute for Pharmaceutical Sciences
ClinicalTrials.gov Identifier: NCT01496911     History of Changes
Other Study ID Numbers: 10-206G/E
First Posted: December 21, 2011    Key Record Dates
Last Update Posted: November 6, 2013
Last Verified: November 2013

Keywords provided by Dr Joris C Verster, Utrecht Institute for Pharmaceutical Sciences:

Additional relevant MeSH terms:
Histamine H1 Antagonists, Non-Sedating
Histamine H1 Antagonists
Histamine Antagonists
Histamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Anti-Allergic Agents
Dermatologic Agents