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

NCT01496911 | Completed Phase 4 DMC

• 1 other identifier: 10-206G/E
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy Volunteers

Keywords

Diving; Drugs; Antihistamines; Performance

Outcome Measures

Primary Outcomes (1)

• Number of errors on the cognitive tests

  acute (up to 3.5 hours after treatment administration)

Secondary Outcomes (1)

• Reaction speed on the cognitive tests

  acute (up to 3.5 hours after treatment administration)

Study Arms (3)

Levocetirizine (5 mg)

EXPERIMENTAL

Drug: Levocetirizine

Hydroxyzine (50 mg)

ACTIVE COMPARATOR

Drug: Hydroxyzine

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

Levocetirizine DRUG

a single oral dose of 5 mg

Levocetirizine (5 mg)

Hydroxyzine DRUG

a single oral dose of 50 mg

Hydroxyzine (50 mg)

Placebo DRUG

a single oral dose

Placebo

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Utrecht Institute for Pharmaceutical Sciences: lead
• Royal Netherlands Navy: collaborator

Study Sites (1)

Royal Netherlands Navy

Den Helder, North Holland, 1780CA, Netherlands

Location

MeSH Terms

Interventions

levocetirizine; Hydroxyzine

Intervention Hierarchy (Ancestors)

Piperazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Joris Verster, PhD

  Utrecht University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant professor

Study Record Dates

• First Submitted: December 19, 2011
• First Posted: December 21, 2011
• Study Start: April 1, 2012
• Primary Completion: October 1, 2012
• Study Completion: October 1, 2012
• Last Updated: November 6, 2013

Record last verified: 2013-11

Locations

NL (1)