Residual effects of zopiclone 7.5 mg and temazepam 20 mg on cognition and actual driving performance in healthy elderly

Phase 1

• Conditions: Healthy elderly volunteers

• Registration Number: EUCTR2006-004305-25-NL
• Lead Sponsor: Maastricht University

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2006-08-03
• Last Update Posted: 8 January 2024

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 18

Inclusion Criteria

1. Age between 55 and 75 years
2. Good health, in the opinion of the medical supervisor, on the basis of a pre-study physical examination, medical history, vital signs, electrocardiogram, and the results of blood biochemistry, haematology, and serology tests, and urinalysis.
3. Possession of a valid driving licence for 3 years or more
4. Driving experience of at least 3000 km per year on average

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1. History of drug or alcohol abuse
2. BMI over 30 kg/m2
3. Chronic use of medication that affects driving performance
4. Smoking more than 10 cigarettes per day
5. Drinking more than 6 cups of coffee per day
6. Drinking more than 21 glasses of alcohol per week

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To assess the residual effects of zopiclone 7.5 mg and temazepam 20 mg on actual driving in healthy elderly volunteers.;Secondary Objective: To compare the residual effects of zopiclone 7.5 mg with those in young volunteers, as found recently in a study using the same tests and procedures (Leufkens & Vermeeren, in prep).;Primary end point(s): Standard Deviation of Lateral Position (SDLP in cm) in the highway driving test. SDLP is a measure of road tracking error; in practical terms, it is a composite index of allowed weaving, swerving, and overcorrecting.