Condition category
Nervous System Diseases
Date applied
21/04/2010
Date assigned
10/06/2010
Last edited
10/06/2010
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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

http://www.bast.de

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

Publication citations

Additional files

Editorial Notes