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

Healthy Volunteers Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01496911
• Other study ID #: 10-206G/E
• Status: Completed
• Phase: Phase 4
• First received: December 19, 2011
• Last updated: November 5, 2013
• Start date: April 2012
• Est. completion date: October 2012

Study information

• Verified date: November 2013
• Source: Utrecht Institute for Pharmaceutical Sciences
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: Medical Ethics Review Committee (METC)
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: October 2012
• Est. primary completion date: October 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 55 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Healthy Volunteers

Intervention

Drug:
• Levocetirizine
a single oral dose of 5 mg
• Hydroxyzine
a single oral dose of 50 mg
• Placebo
a single oral dose

Locations

Country	Name	City	State
Netherlands	Royal Netherlands Navy	Den Helder	Noord Holland

Sponsors (2)

Lead Sponsor	Collaborator
Utrecht Institute for Pharmaceutical Sciences	Royal Netherlands Navy

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of errors on the cognitive tests		acute (up to 3.5 hours after treatment administration)	No
Secondary	Reaction speed on the cognitive tests		acute (up to 3.5 hours after treatment administration)	No