Contact information
Type
Scientific
Primary contact
Dr Annemiek Vermeeren
ORCID ID
Contact details
Universiteitssingel 40
Maastricht
6229ER
Netherlands
a.vermeeren@maastrichtuniversity.nl
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
EPU-P31
Study information
Scientific title
Effects of insomnia and chronic use of hypnotics on driving performance: a parallel group comparison trial
Acronym
Study hypothesis
The present study aims to determine whether driving performance of chronic users of hypnotics and unmedicated insomnia patients differs from normal sleepers of the same age.
Ethics approval
Medical Ethics Committee of Maastricht University and University Hospital of Maastricht approved on the 20th June 2007 (ref: MEC 07-3-040)
Study design
3 x 2 parallel group comparison trial
Primary study design
Interventional
Secondary study design
Non randomised controlled trial
Trial setting
Other
Trial type
Quality of life
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Insomnia
Intervention
3 x 2 parallel group design with three groups (chronic users, unmedicated insomnia patients, controls) and two within subject conditions (habituation and baseline).
Subjects were individually trained to perform the laboratory tests during two sessions of approximately 1.5 hours within 10 days before their first night. After training the subjects underwent two nights of sleep evaluation. The first night was a habituation and practice condition to familiarize subjects with the sleeping facilities and polysomnographic and test procedures. The second night was considered as the actual test condition.
A test condition started in the evening of Day 1, when the subjects arrived at the site at approximately 19:00 hours, and lasted until Day 2, when they were discharged at approximately 11:45 hours. On arrival at the sleeping facility, subjects rated their subjective feelings and subjective sleepiness. From 19:30 hours until 20:30 hours they performed the first session of laboratory tests, comprising the Word Learning Test immediate and first delayed recall, the Critical Tracking Task, the Divided Attention Task, the Psychomotor Vigilance Task, the Stop Signal Task, and the Digit Span forward and backward. Hereafter, electrodes for polysomnographic recording were attached.
Subjects retired to bed at 23:30 hours. Immediately preceding retiring, subjects in the chronic users group ingested their own prescribed hypnotic, whereas subjects in the unmedicated insomniacs group and controls did not ingest medication. Subjects were awakened at 07:30 hours and after arising a light standardized breakfast was served. At 08:00 hours subjects evaluated sleep quality and duration, and feelings of daytime sleepiness and alertness. Subsequently, they started the second session of laboratory tests, comprising the Word Learning Test second delayed recall and recognition, the Critical Tracking Task, the Divided Attention Task, the Psychomotor Vigilance Task, and the Digit Span forward and backward. At 9:00 hours blood samples were taken from the chronic users to determine serum concentrations of hypnotics before driving. Thereafter subjects were transported to the Highway Driving Test which they performed between 09:30 and 10:30 hours. Upon completion subjects rated the mental effort it took to perform this driving test, and subsequently they conducted the Car-Following Test. Upon completion of this test subjects returned to the testing facilities for removal of the electrodes and were discharged.
Intervention type
Other
Phase
Not Applicable
Drug names
Primary outcome measures
Standard Deviation of Lateral Position (SDLP in cm) in the highway driving test
Secondary outcome measures
1. Time to speed adaptation (in sec) and brake reaction time (in msec) in the car following test
2. Cognitive and psychomotor tests
Overall trial start date
01/06/2007
Overall trial end date
31/12/2008
Reason abandoned
Eligibility
Participant inclusion criteria
1. Healthy (except for patients complaints of insomnia)
2. Aged 55 year of older, either sex
3. Possession of a valid drivers license
4. Average annual driving experience of 3000 km per year over the last three years
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
75 patients (25 in each group)
Participant exclusion criteria
1. Abuse of alcohol, nicotine and caffeine
2. Use of medication that might affect driving performance (except hypnotics)
3. For patients:
3.1. Sleep-related breathing disorders
3.2. Circadian rhythm sleep disorders
3.3. Sleep related movement disorders
Recruitment start date
01/06/2007
Recruitment end date
31/12/2008
Locations
Countries of recruitment
Netherlands
Trial participating centre
Universiteitssingel 40
Maastricht
6229ER
Netherlands
Sponsor information
Organisation
Federal Highway Research Institute (Bundesanstalt für Straßenwesen) (Germany)
Sponsor details
DRUID-Project
Brüderstrasse 53
Bergisch Gladbach
D-51427
Germany
druid@bast.de
Sponsor type
Research organisation
Website
Funders
Funder type
Government
Funder name
European Union (EU) (Belgium) - Sixth Framework Programme (FP6): Driving Under the Influence of Drug, Alcohol and Medicine (DRUID)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary