Effects of Levocetirizine and Hydroxyzine on Cognitive and Psychomotor Functioning During Simulated Diving
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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 |
- Number of errors on the cognitive tests [ Time Frame: acute (up to 3.5 hours after treatment administration) ] [ Designated as safety issue: No ]
- Reaction speed on the cognitive tests [ Time Frame: acute (up to 3.5 hours after treatment administration) ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 24 |
| Study Start Date: | March 2012 |
| Estimated Study Completion Date: | July 2012 |
| Estimated Primary Completion Date: | July 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 |
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| Contact: Joris Verster, PhD | 0031302536909 | j.c.verster@uu.nl |
| Netherlands | |
| Royal Netherlands Navy | Not yet recruiting |
| Den Helder, Noord Holland, Netherlands, 1780CA | |
| Contact: Rob van Hulst, MD, PhD ra.vanhulst@mindef.nl | |
| Principal Investigator: Rob van Hulst, MD, PhD | |
| 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: | December 21, 2011 |
| 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 May 21, 2013