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

• Status: Completed
• Trial end date: 2012-10-01
• Target enrollment: 0
• Participant gender: Male

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Utrecht Institute for Pharmaceutical Sciences
• Collaborator: Royal Netherlands Navy
• Treatments: Cetirizine; Hydroxyzine; Levocetirizine

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