Insomnia, hypnotics and driving
| ISRCTN | ISRCTN47723701 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN47723701 |
| Secondary identifying numbers | EPU-P31 |
- Submission date
- 21/04/2010
- Registration date
- 10/06/2010
- Last edited
- 19/09/2019
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Nervous System Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Annemiek Vermeeren
Scientific
Scientific
Universiteitssingel 40
Maastricht
6229ER
Netherlands
| a.vermeeren@maastrichtuniversity.nl |
Study information
| Study design | 3 x 2 parallel group comparison trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Non randomised controlled trial |
| Study setting(s) | Other |
| Study type | Quality of life |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | Effects of insomnia and chronic use of hypnotics on driving performance: a parallel group comparison trial |
| Study objectives | 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(s) | Medical Ethics Committee of Maastricht University and University Hospital of Maastricht approved on the 20th June 2007 (ref: MEC 07-3-040) |
| Health condition(s) or problem(s) studied | 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 |
| Primary outcome measure | 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 study start date | 01/06/2007 |
| Completion date | 31/12/2008 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 75 patients (25 in each group) |
| Total final enrolment | 63 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 01/06/2007 |
| Date of final enrolment | 31/12/2008 |
Locations
Countries of recruitment
- Netherlands
Study participating centre
Universiteitssingel 40
Maastricht
6229ER
Netherlands
6229ER
Netherlands
Sponsor information
Federal Highway Research Institute (Bundesanstalt für Straßenwesen) (Germany)
Research organisation
Research organisation
DRUID-Project
Brüderstrasse 53
Bergisch Gladbach
D-51427
Germany
| druid@bast.de | |
| Website | http://www.bast.de |
"ROR" |
https://ror.org/046nzaj59 |
Funders
Funder type
Government
European Union (EU) (Belgium) - Sixth Framework Programme (FP6): Driving Under the Influence of Drug, Alcohol and Medicine (DRUID)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/07/2014 | 19/09/2019 | Yes | No |
Editorial Notes
19/09/2019: Publication reference and total final enrolment added.
