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
  Purpose

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 Intervention Phase
Healthy Volunteers
Drug: Levocetirizine
Drug: Hydroxyzine
Drug: Placebo
Phase 4

Study Type: Interventional
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

Resource links provided by NLM:


Further study details as provided by Utrecht Institute for Pharmaceutical Sciences:

Primary Outcome Measures:
  • Number of errors on the cognitive tests [ Time Frame: acute (up to 3.5 hours after treatment administration) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Reaction speed on the cognitive tests [ Time Frame: acute (up to 3.5 hours after treatment administration) ] [ Designated as safety issue: No ]

Enrollment: 24
Study Start Date: April 2012
Study Completion Date: October 2012
Primary Completion Date: October 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01496911

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

No publications provided

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
Study First Received: December 19, 2011
Last Updated: November 5, 2013
Health Authority: Netherlands: Medical Ethics Review Committee (METC)

Keywords provided by Utrecht Institute for Pharmaceutical Sciences:
Diving
Drugs
Antihistamines
Performance

Additional relevant MeSH terms:
Hydroxyzine
Levocetirizine
Cetirizine
Antipruritics
Dermatologic Agents
Therapeutic Uses
Pharmacologic Actions
Histamine H1 Antagonists
Histamine Antagonists
Histamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Histamine H1 Antagonists, Non-Sedating
Anti-Allergic Agents

ClinicalTrials.gov processed this record on September 30, 2014