Effects of insomnia and chronic use of hypnotics on driving performance

Phase 4

Completed

• Conditions: 10040998; sleep problems; insomnia

• Registration Number: NL-OMON31127
• Lead Sponsor: niversiteit Maastricht

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 13 May 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 75

Inclusion Criteria

healthy (except for patients with complaints of insomnia)
age 55 year or older
possession of a valid drivers license
average annual driving experience of 3000 km per year over the last three years

Exclusion Criteria

abuse of alcohol, nicotine and cafeine
use of medication that might affect driving performance (except hypnotics)
For patients: Sleep-Related Breathing Disorders; Circadian Rhythm Sleep Disorders; Sleep-Related Movement Disorders

Study & Design

• Study Type: Observational invasive
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The main study parameter is Standard Deviation of Lateral Position (SDLP in cm)<br /><br>in the highway driving test.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Time to speed adaptation (in msec) and brake reaction time (in msec) in the car<br /><br>following test.<br /><br>Cognitive and psychomotor tests: 15-Word Learning Test; Critical Tracking Task;<br /><br>Divided Attention Task; Stop Signal Task; Psychomotor Vigilance Task; Digit<br /><br>Span Backward and Forward.<br /><br>Subjective evaluations: Subjective alertness BOnd &Lader Visual Analogue<br /><br>Scales.</p><br>