Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12618001250224
Ethics application status
Approved
Date submitted
17/07/2018
Date registered
24/07/2018
Date last updated
1/05/2019
Date data sharing statement initially provided
1/05/2019
Date results information initially provided
1/05/2019
Type of registration
Retrospectively registered

Titles & IDs
Public title
Assessment of fatigue in motor vehicle drivers with and without sleep apnoea.
Scientific title
Validating Fatigue Crash Risk and Ocular Measures of Alertness in Drivers with Sleep Apnoea.
Secondary ID [1] 295455 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Sleep apnoea 308709 0
Condition category
Condition code
Respiratory 307649 307649 0 0
Sleep apnoea

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
We are conducting a research study investigating the effect of fatigue on driving performance. Participation in the study will involve monitoring your driving habits and eye blinks for 7 days. You will be asked to fill out a driving diary and wear special glasses when you drive. The glasses will not affect your ability to drive. There is no minimum amount of driving expected during the 7 days. However we will only recruit individuals who drive on average more than 4 hours per week.
Intervention code [1] 301765 0
Early Detection / Screening
Comparator / control treatment
Participants with sleep apnoea will be compared to healthy control participants.
Control group
Active

Outcomes
Primary outcome [1] 306635 0
Ocular parameters (specifically eye blink characteristics) - via infrared glasses
Timepoint [1] 306635 0
Days 1-7 of observation period
Primary outcome [2] 306636 0
Objective sleepiness via actigrahy which provides a measure of sleep and wake patterns (based on movement).
Timepoint [2] 306636 0
Days 1-7 of observation period
Primary outcome [3] 306637 0
Psychomotor vigilance performance will be assessed using a portable handheld device that measures reaction times to repeated presentation of a light stimulus over a period of 10 minutes,
Timepoint [3] 306637 0
Days 1-7 of observation period
Secondary outcome [1] 349090 0
Subjective sleepiness prior to the psychomotor vigilance performance via a validated sleepiness scale the Karolinkska Sleepiness Scale which ranges from 0-9.
.
Timepoint [1] 349090 0
Days 1-7 of observation period
Secondary outcome [2] 349091 0
Sleepiness Symptoms Questionnaire - Participants will fill in a sleepiness symptoms questionnaire that asks them whether they experienced signs of sleepiness during their drive. There is eight signs of sleepiness and participants rate them from 1-7. These can then be scored as a composite or individual measures.
Timepoint [2] 349091 0
Days 1-7 of the observation
Secondary outcome [3] 349866 0
Sleep duration - Participants will mark sleep onset and offset and estimated sleep latency time so that subjective sleep duration can be calculated.
Timepoint [3] 349866 0
Days 1-7 of the observation.
Secondary outcome [4] 349867 0
Drive duration- Participants will mark drive start and stop times.
Timepoint [4] 349867 0
Days 1-7 of the observation
Secondary outcome [5] 349868 0
Drive distance - Participants will mark odometer kilometres at the beginning and end of each of their drive sessions so that drive distance can be calculation
Timepoint [5] 349868 0
Days 1-7 of the observation
Secondary outcome [6] 349869 0
Near-miss accident and accidents- Participants will mark if they had a near miss (yes/no) and/or an accident (yes/no)during each of their drives
Timepoint [6] 349869 0
Days 1-7 of the observation
Secondary outcome [7] 349870 0
Subjective sleepiness rated pre and post driving session via the Karolinska Sleepiness Scale - ranges from 0-9
Timepoint [7] 349870 0
Days 1-7 of the observation
Secondary outcome [8] 349928 0
Participant recorded number of passengers in the car during driving sessions.
Timepoint [8] 349928 0
Days 1-7 of the observation

Eligibility
Key inclusion criteria
All participants
Aged 21-80
Non-smoker
Have held a current driver license for at least 3 years
Have driven an average of 5000 km or more per year or drive more than 4 hours a week

Sleep Apnoea Participants:
- Have moderate to severe sleep apnoea (Apnea-Hypopnea Index > 15 events per hour)
Minimum age
21 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Conditions that contraindicate driving (e.g. epilepsy, etc)
Regular use of benzodiazepine and analgesic medication
Current night shift worker
Impaired vision that cannot be corrected with glasses
Difficulty understanding, reading and writing in English
Pregnant women

Sleep apnoea participant specific exclusion criteria -
Currently treated for OSA

Study design
Purpose
Natural history
Duration
Cross-sectional
Selection
Case control
Timing
Prospective
Statistical methods / analysis
20 participants in a sleep apnoea and 20 participants in a healthy control group were selected to provide pilot data. Data will be assessed primarily using a between groups comparisons for the sleep apnoea and healthy control group. Within-subject changes will also be assessed.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
14/02/2013
Date of last participant enrolment
Anticipated
Actual
19/02/2019
Date of last data collection
Anticipated
Actual
26/02/2019
Sample size
Target
40
Accrual to date
Final
35
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 11332 0
Austin Health - Austin Hospital - Heidelberg
Recruitment postcode(s) [1] 23229 0
3084 - Heidelberg

Funding & Sponsors
Funding source category [1] 300045 0
Other Collaborative groups
Name [1] 300045 0
Institute for Breathing and Sleep
Country [1] 300045 0
Australia
Primary sponsor type
Other Collaborative groups
Name
Institute for Breathing and Sleep
Address
Institute for Breathing and Sleep
Bowen Centre, Austin Hospital
145 Studley Road
Heidelberg, Victoria, 3084
Country
Australia
Secondary sponsor category [1] 299438 0
None
Name [1] 299438 0
Address [1] 299438 0
Country [1] 299438 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 300892 0
Austin Health Human Research Ethics Committee
Ethics committee address [1] 300892 0
Austin Health
Level 8, Harold Stokes Building
Austin Health
PO Box 5555
Heidelberg
Victoria
Australia 3084
Ethics committee country [1] 300892 0
Australia
Date submitted for ethics approval [1] 300892 0
Approval date [1] 300892 0
26/11/2012
Ethics approval number [1] 300892 0

Summary
Brief summary
The purpose of this study is to determine whether drowsiness during driving can be detected by using eye blink measures. In particular we are interested in determining whether eye blink measures differ between individuals with sleep apnoea and healthy individuals during their regular driving. Sleep apnoea participants will be matched with healthy participants in respect to age (within 5 years) and gender, It is anticipated that sleep apnoea group will be more tired and this will be demonstrated in their eye blink measures. The study is observational., The main outcome measures are eye blinks, self-reported and measured sleepiness, reaction times and driving habits.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 85182 0
A/Prof Mark Howard
Address 85182 0
Institute for Breathing and Sleep
Bowen Centre, Austin Hospital
145 Studley Road
Heidelberg, Victoria, 3084
Country 85182 0
Australia
Phone 85182 0
+61 3 9496 5390
Fax 85182 0
Email 85182 0
mark.howard@austin.org.au
Contact person for public queries
Name 85183 0
Dr Jennifer Cori
Address 85183 0
Institute for Breathing and Sleep
Bowen Centre, Austin Hospital
145 Studley Road
Heidelberg, Victoria, 3084
Country 85183 0
Australia
Phone 85183 0
+61 3 94963528
Fax 85183 0
Email 85183 0
jennifer.cori@austin.org.au
Contact person for scientific queries
Name 85184 0
Dr Jennifer Cori
Address 85184 0
Institute for Breathing and Sleep
Bowen Centre, Austin Hospital
145 Studley Road
Heidelberg, Victoria, 3084
Country 85184 0
Australia
Phone 85184 0
+61 3 9496 3528
Fax 85184 0
Email 85184 0
jennifer.cori@austin.org.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Was not in ethics at time of project commencement


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.