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Trial registered on ANZCTR

Registration number
Ethics application status
Not yet submitted
Date submitted
Date registered
Date last updated
Type of registration
Prospectively registered

Titles & IDs
Public title
Trial of an at home screening program for investigation of obstructive sleep apnoea in rail safety workers
Scientific title
Trial of an at home screening program for investigation of obstructive sleep apnoea in rail safety workers
Secondary ID [1] 259620 0
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Obstructive Sleep Apnoea 261165 0
Condition category
Condition code
Respiratory 259318 259318 0 0
Sleep apnoea

Study type
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Participants who meet the inclusion criteria will undertake an at home sleep assessment via a portable home monitoring device to screen for obstructive sleep apnoea.

Participants will be given instruction on how to operate and administer this device by an occupational health nurse during their routine medical assessments. The device is about the size of a mobile telephone. Participants will take the device home for use on the night of their periodic Rail Safety assessment.

The device (the "ApneaLink") is a portable battery powered 3 channel unit that measures:
1. nasal flow (via nasal cannulae)
2. oxygen saturation (via finger sensor)
3. chest expansion (via a chest strap)

Participants will undertake the study in their own home/bed, and will be instructed to attach the leads and turn the device on around 15-20 minutes before sleep. They will then be asked to turn the unit off when they wake the next morning, after preferably at least 6 hours of sleep time in between.

The above parameters are recorded via the unit, and data will be extracted the next day once the unit is returned to study centre. The data will then be extracted and analysed to assess whether or not there are any periods of apnoea (cessation of breathing) or hyponoea (reduced breathing) during sleep. A sleep physician will then interpret the data and give opinion as to whether or not there are any characteristics of obstructive sleep apnoea.
Intervention code [1] 258028 0
Not applicable
Comparator / control treatment
Epworth Sleepiness Score - participants acting as own controls.
Control group

Primary outcome [1] 262135 0
Early screening/detection of obstructive sleep apnoea in safety critical workers who attend periodic medical assessments.

This outcome will be assessed via the data taken fromthe ApneaLink device, which will be interpreted by a sleep physician once data has been extracted.
Timepoint [1] 262135 0
Within 5 working days of undertaking portable home monitor test.
Secondary outcome [1] 273217 0
Comparison of inclusion criteria with (self reported) Epworth Sleepiness Scale.
Timepoint [1] 273217 0
Within 5 working days of undertaking portable home monitor test.

Key inclusion criteria
Railcorp Safety Critical Workers
body mass index >35
neck circumference >43 cm
known hypertension or systolic blood pressure >150mmHg
or impaired glucose tolerance or known diabetes mellitus
Minimum age
30 Years
Maximum age
65 Years
Can healthy volunteers participate?
Key exclusion criteria
- non railcorp safety critical workers
- known obstructive sleep apnoea or other sleep disordered breathing

Study design
Defined population
Statistical methods / analysis

Recruitment status
Not yet recruiting
Date of first participant enrolment
Date of last participant enrolment
Date of last data collection
Sample size
Accrual to date
Recruitment in Australia
Recruitment state(s)
Recruitment postcode(s) [1] 3623 0

Funding & Sponsors
Funding source category [1] 258513 0
Commercial sector/Industry
Name [1] 258513 0
Railcorp Chief Health Officer Division
Address [1] 258513 0
Level 26, 477 Pitt Street Sydney NSW 2000
Country [1] 258513 0
Primary sponsor type
Commercial sector/Industry
Medibank Health Solutions
Level 4, 136 Chalmers St Surry Hills NSW 2010
Secondary sponsor category [1] 257654 0
Name [1] 257654 0
Address [1] 257654 0
Country [1] 257654 0

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 260485 0
University of New South Wales
Ethics committee address [1] 260485 0
Kensington NSW 2052
Ethics committee country [1] 260485 0
Date submitted for ethics approval [1] 260485 0
Approval date [1] 260485 0
Ethics approval number [1] 260485 0

Brief summary
The aim of this pilot study is to assess whether or not objective health criteria (inclusion criteria), coupled with a portable home monitor (ApneaLink) could be a more reliable and valid method of screening for obstructive sleep apnoea in Rail Safety Workers, when compared with the current self reported Epworth Sleepiness Scale.
Trial website
Trial related presentations / publications
Public notes

Principal investigator
Name 32213 0
Address 32213 0
Country 32213 0
Phone 32213 0
Fax 32213 0
Email 32213 0
Contact person for public queries
Name 15460 0
Dr Chris Colquhoun
Address 15460 0
Medibank Health Solutions
Level 4, 136 Chalmers St Surry Hills NSW 2010
Country 15460 0
Phone 15460 0
+61 413 250 813
Fax 15460 0
+61 2 83960689
Email 15460 0
Contact person for scientific queries
Name 6388 0
Dr Chris Colquhoun
Address 6388 0
Medibank Health Solutions
Level 4, 136 Chalmers St Surry Hills NSW 2010
Country 6388 0
Phone 6388 0
+61 413 250 813
Fax 6388 0
+61 2 83960689
Email 6388 0

No information has been provided regarding IPD availability
Summary results
No Results