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

Sponsor

Utrecht Institute for Pharmaceutical Sciences (Other)

Overall Status

Completed

CT.gov ID

NCT01496911

Collaborator

Royal Netherlands Navy (Other)

Enrollment

Location

Arms

Duration (Months)

Patients Per Site Per Month

Study Details

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

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 :

Apr 1, 2012

Actual Primary Completion Date :

Oct 1, 2012

Actual Study Completion Date :

Oct 1, 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

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

Number of errors on the cognitive tests [acute (up to 3.5 hours after treatment administration)]

Secondary Outcome Measures

Reaction speed on the cognitive tests [acute (up to 3.5 hours after treatment administration)]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 55 Years

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

Locations

	Site	City	State	Country	Postal Code
1	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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Dr Joris C Verster, Assistant professor, Utrecht Institute for Pharmaceutical Sciences

ClinicalTrials.gov Identifier:

NCT01496911

Other Study ID Numbers:

10-206G/E

First Posted:

Dec 21, 2011

Last Update Posted:

Nov 6, 2013

Last Verified:

Nov 1, 2013

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

Additional relevant MeSH terms:

Hydroxyzine

Levocetirizine

Study Results

No Results Posted as of Nov 6, 2013