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

This study has been completed.
Sponsor:
Collaborator:
Royal Netherlands Navy
Information provided by (Responsible Party):
Dr Joris C Verster, Utrecht Institute for Pharmaceutical Sciences
ClinicalTrials.gov Identifier:
NCT01496911
First received: December 19, 2011
Last updated: November 5, 2013
Last verified: November 2013

December 19, 2011
November 5, 2013
April 2012
October 2012   (final data collection date for primary outcome measure)
Number of errors on the cognitive tests [ Time Frame: acute (up to 3.5 hours after treatment administration) ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01496911 on ClinicalTrials.gov Archive Site
Reaction speed on the cognitive tests [ Time Frame: acute (up to 3.5 hours after treatment administration) ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Effects of Levocetirizine and Hydroxyzine on Cognitive and Psychomotor Functioning During Simulated Diving
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.

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Basic Science
Healthy Volunteers
  • Drug: Levocetirizine
    a single oral dose of 5 mg
  • Drug: Hydroxyzine
    a single oral dose of 50 mg
  • Drug: Placebo
    a single oral dose
  • Experimental: Levocetirizine (5 mg)
    Intervention: Drug: Levocetirizine
  • Active Comparator: Hydroxyzine (50 mg)
    Intervention: Drug: Hydroxyzine
  • Placebo Comparator: Placebo
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
24
October 2012
October 2012   (final data collection date for primary outcome measure)

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
Male
18 Years to 55 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Netherlands
 
NCT01496911
10-206G/E
Yes
Dr Joris C Verster, Utrecht Institute for Pharmaceutical Sciences
Utrecht Institute for Pharmaceutical Sciences
Royal Netherlands Navy
Principal Investigator: Joris Verster, PhD Utrecht University
Utrecht Institute for Pharmaceutical Sciences
November 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP