Trial Review

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
Help: Registration number
ACTRN12611000185965
Ethics application status
Help: Ethics application status
Not yet submitted
Date submitted
Help: Date submitted
16/02/2011
Date registered
Help: Date registered
16/02/2011
Date last updated
Help: Date last updated
16/02/2011
Type of registration
Help: 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
Additional trial identifiers [1] 259620 0
nil
Universal Trial Number (UTN)
nil
Trial acronym
nil
Related trial records

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

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of the intervention or 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
Description of the comparator or control
Epworth Sleepiness Score - participants acting as own controls.
Control group
Uncontrolled

Outcomes
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.

Eligibility
Key inclusion criteria
Railcorp Safety Critical Workers
males
body mass index >35
neck circumference >43 cm
with:
known hypertension or systolic blood pressure >150mmHg
or impaired glucose tolerance or known diabetes mellitus
Minimum age
30 Years
Maximum age
65 Years
Sex
Males
Healthy volunteers
No
Key exclusion criteria
- non railcorp safety critical workers
- known obstructive sleep apnoea or other sleep disordered breathing

Study design
Purpose
Screening
Duration
Cross-sectional
Selection
Defined population
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/04/2011
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
100
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment postcode(s) [1] 3623 0
2010

Funding & Sponsors
Funding source category [1] 258513 0
Commercial sector/Industry
Name [1] 258513 0
Railcorp Chief Health Officer Division
Country [1] 258513 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
Medibank Health Solutions
Address
Level 4, 136 Chalmers St Surry Hills NSW 2010
Country
Australia
Secondary sponsor category [1] 257654 0
None
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
Ethics committee country [1] 260485 0
Australia
Date submitted for ethics approval [1] 260485 0
01/03/2011
Approval date [1] 260485 0
Ethics approval number [1] 260485 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
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
Australia
Phone 15460 0
+61 413 250 813
Fax 15460 0
+61 2 83960689
Email 15460 0
[email protected]
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
Australia
Phone 6388 0
+61 413 250 813
Fax 6388 0
+61 2 83960689
Email 6388 0
[email protected]

No information has been provided regarding IPD availability


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.