Effects of sleep deprivation and low blood alcohol on driving capacities in young people
| ISRCTN | ISRCTN81246006 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN81246006 |
| Secondary identifying numbers | Canadian Institutes of Health Research MOP-123346 |
- Submission date
- 31/01/2014
- Registration date
- 10/02/2014
- Last edited
- 12/02/2021
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Injury, Occupational Diseases, Poisoning
Plain English summary of protocol
Background and study aims
Driving while sleep deprived and after alcohol consumption are frequently suspected in road traffic crashes among young drivers. The effects of sleep deprivation on driving can be increased even at low legal levels of blood alcohol. This study aims to clarify how and to what degree sleep deprivation combined with low, legal levels of alcohol consumption influences driving in young drivers.
Who can participate?
Male and female drivers aged 18-25 years and 30-34 years.
What does the study involve?
The effects of combined sleep deprivation and low legal alcohol levels on simulated driving performance will be compared to either of these conditions alone.
Participants are randomly allocated to one of four groups:
1. No alcohol intake, no partial sleep deprivation
2. Alcohol intake, no partial sleep deprivation
3. No alcohol intake, partial sleep deprivation (1 hour less of sleep/night over a one-week period)
4. Alcohol intake, partial sleep deprivation (1 hour less of sleep/night over a one-week period)
What are the possible benefits and risks of participating?
Participants receive a maximum compensation of 250 Canadian dollars for their time and transport.
About 5% of participants may suffer simulation sickness that includes dizziness, nausea and vomiting. We screen for simulation sickness during a driving simulation practice session lasting about 10 minutes. We advise participants to reduce or avoid driving during their participation. To avoid any risks following alcohol administration, participants
are advised to leave the laboratory only after their blood alcohol drops to 0%. Taxis are made available to participants if they feel fatigued following the experimental sessions.
Where is the study run from?
Douglas Mental Health University Institute Research Centre in Montreal, Canada.
When is the study starting and how long is it expected to run for?
The study will start recruiting participants in February 2014 and will run until March 2016.
Who is funding the study?
Canadian Institutes of Health Research (CIHR) and a consortium made up of Quebec Society & Culture Research Foundation (Fonds de Recherche du Québec Société et Culture - FQRSC), Quebec Motorcar Insurance Company (Société de lAssurance Automobile de Québec - SAAQ) and Quebec Health Research Foundation (Fonds de Recherche du Québec Santé - FRSQ), Canada.
Who is the main contact?
Dr Thomas G Brown
thomas.brown@mcgill.ca
Contact information
Scientific
Douglas Mental Health University Institute Research Centre
6875 Boulevard LaSalle, Perry 4116
Montreal
H4H 1R3
Canada
| Phone | +1 514 761 6131 ext. 3415 |
|---|---|
| thomas.brown@mcgill.ca |
Study information
| Study design | Randomized controlled trial - double blinded for sleep deprivation induction and alcohol dose |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Other |
| Study type | Diagnostic |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | Effects of sleep deprivation and low blood alcohol on executive functions in young drivers: a randomized controlled trial |
| Study objectives | To compare the effects of cumulative sleep deprivation and legal blood alcohol levels on the safe driving capacities of young people. |
| Ethics approval(s) | Douglas Mental Health University Institute Review Ethics Board, 17/01/2014, ref. REB#12/18 |
| Health condition(s) or problem(s) studied | Injury prevention, driving while impaired by alcohol and/or sleep deprived |
| Intervention | The participants are randomised to one of four conditions. 1. No alcohol intake, no partial sleep deprivation 2. Alcohol intake [blood alcohol concentration (BAC) = 0.03%], no partial sleep deprivation 3. No alcohol, partial sleep deprivation (1 hour less of sleep/night over a one week period) 4. Alcohol (BAC = 0.03%), partial sleep deprivation (1 hour less of sleep/night over a one week period) One follow-up session is involved for measurement of simulated driving performance. |
| Intervention type | Other |
| Primary outcome measure | Driving performance on the driving simulator measured at intake and one week following randomization to condition and the partial sleep deprivation induction protocol. |
| Secondary outcome measures | Performance on neuropsychological executive function tasks |
| Overall study start date | 01/02/2014 |
| Completion date | 31/12/2017 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 34 Years |
| Sex | Both |
| Target number of participants | 300 |
| Total final enrolment | 93 |
| Key inclusion criteria | 1. Male and female drivers aged 18-25 years and 30-34 years, having drunk alcohol in the past 6 months 2. Having driven in the past 3 months 3. Medication-free (except contraceptives for females) 4. Usually sleeps during regular night-time hours |
| Key exclusion criteria | 1. Attention-deficit hyperactivity disorder diagnosis 2. Signs of alcohol dependence 3. Signs of drug dependence 4. Sleep problems 5. Pregnancy or breastfeeding |
| Date of first enrolment | 01/02/2014 |
| Date of final enrolment | 31/03/2016 |
Locations
Countries of recruitment
- Canada
Study participating centre
H4H 1R3
Canada
Sponsor information
Research organisation
6875 LaSalle Boulevard
Perry Pavilion, Fourth Floor, E-4206
Montreal
H4H 1R3
Canada
| Phone | +1 514 761 6131 Ext. 3158 |
|---|---|
| catherine.cattan@douglas.mcgill.ca | |
| Website | http://www.douglas.qc.ca/page/administration |
"ROR" |
https://ror.org/05dk2r620 |
Funders
Funder type
Government
Government organisation / National government
- Alternative name(s)
- Instituts de Recherche en Santé du Canada, Canadian Institutes of Health Research (CIHR), CIHR_IRSC, Canadian Institutes of Health Research | Ottawa ON, CIHR, IRSC
- Location
- Canada
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 | 01/02/2019 | 12/02/2021 | Yes | No |
Editorial Notes
12/02/2021: The following changes were made to the trial record:
1. Publication reference added.
2. The total final enrolment was added.
03/03/2017: Trial end date was changed from 31/03/2016 to 31/12/2017.
