Please note that the copy function is not enabled for this field.
If you wish to
modify
existing outcomes, please copy and paste the current outcome text into the Update field.
LOGIN
CREATE ACCOUNT
LOGIN
CREATE ACCOUNT
MY TRIALS
REGISTER TRIAL
FAQs
HINTS AND TIPS
DEFINITIONS
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
Download to PDF
Trial registered on ANZCTR
Registration number
ACTRN12611000100998
Ethics application status
Approved
Date submitted
21/01/2011
Date registered
28/01/2011
Date last updated
3/11/2022
Date data sharing statement initially provided
3/11/2022
Date results information initially provided
3/11/2022
Type of registration
Retrospectively registered
Titles & IDs
Public title
The Effect of Head Posture on Collapsibility of the Human Upper Airway During Sleep, Sedation & Anaesthesia
Query!
Scientific title
The Effect of Head Posture on Collapsibility of the Human Upper Airway During Sleep, Sedation & Anaesthesia in Participants With and Without Obstructive Sleep Apnoea
Query!
Secondary ID [1]
253461
0
Sir Charles Gairdner Human Research Ethics Number: 2009-037
Query!
Universal Trial Number (UTN)
U1111-1119-2057
Query!
Trial acronym
Query!
Linked study record
Query!
Health condition
Health condition(s) or problem(s) studied:
Obstructive Sleep Apnoea
261014
0
Query!
Condition category
Condition code
Respiratory
259151
259151
0
0
Query!
Sleep apnoea
Query!
Intervention/exposure
Study type
Interventional
Query!
Description of intervention(s) / exposure
Measurements of upper airway collapsibility will be obtained with the subjects head in three positions, namely neutral, flexed (maximum comfort threshold) or extended (maximum comfort threshold), during both sleep and anaesthesia. Each subject will be studied on two separate occassions, once during an overnight sleep study and the once during a daytime anaesthesia study. The order of the sleep and anaesthesia studies will be at the discretion of the treating physician and will be separated by a 48 hour washout period.
Head position and jaw position will be maintaned using a foam head rest support (Dunlop Foams) and manipulated using a custom built device. The order of the head positions will be choosen in accordance with the subjects preference.
Query!
Intervention code [1]
257904
0
Treatment: Devices
Query!
Comparator / control treatment
Neutral head posture
Query!
Control group
Active
Query!
Outcomes
Primary outcome [1]
262003
0
Upper airway collapsibility as measured by pharyngeal critical closing pressure
Query!
Assessment method [1]
262003
0
Query!
Timepoint [1]
262003
0
During sleep and anaesthesia under each head/neck posture condition i.e. in the neutral, flexed and extended posture.
Query!
Secondary outcome [1]
268933
0
Nil
Query!
Assessment method [1]
268933
0
Query!
Timepoint [1]
268933
0
Nil
Query!
Eligibility
Key inclusion criteria
Inclusion criteria for healthy subjects:
Apnoea hypopnoea index less than or equal to 5 events per hour
Aged between 20 and 70 years
Body mass index between 20 and 35 kg.m2
Normal lung function
Epworth Sleepiness Score of less than or equal to 9
Inclusion criteria for obstructive sleep apnoeic subjects:
Apnoea hypopnoea index greater than 5 events per hour
Aged between 20 and 70 years
Body mass index between 20 and 35 kg.m2
Normal lung function
Epworth Sleepiness Score greater than 9
Query!
Minimum age
20
Years
Query!
Query!
Maximum age
70
Years
Query!
Query!
Sex
Both males and females
Query!
Can healthy volunteers participate?
Yes
Query!
Key exclusion criteria
Functional anatomical abnormalities of the head and heck
Unable to lie/sleep supine for lengthy periods
Uncontrolled hypertension or stroke
Diagnosis of heart failure
Pregnancy
Query!
Study design
Purpose of the study
Treatment
Query!
Allocation to intervention
Randomised controlled trial
Query!
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Query!
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Query!
Masking / blinding
Open (masking not used)
Query!
Who is / are masked / blinded?
Query!
Query!
Query!
Query!
Intervention assignment
Crossover
Query!
Other design features
Query!
Phase
Not Applicable
Query!
Type of endpoint/s
Efficacy
Query!
Statistical methods / analysis
Query!
Recruitment
Recruitment status
Completed
Query!
Date of first participant enrolment
Anticipated
7/12/2010
Query!
Actual
9/12/2010
Query!
Date of last participant enrolment
Anticipated
Query!
Actual
30/12/2013
Query!
Date of last data collection
Anticipated
Query!
Actual
30/12/2013
Query!
Sample size
Target
17
Query!
Accrual to date
Query!
Final
31
Query!
Recruitment in Australia
Recruitment state(s)
WA
Query!
Recruitment hospital [1]
23497
0
Sir Charles Gairdner Hospital - Nedlands
Query!
Recruitment postcode(s) [1]
38903
0
6009 - Nedlands
Query!
Funding & Sponsors
Funding source category [1]
258378
0
Government body
Query!
Name [1]
258378
0
National Health & Medical Research Council
Query!
Address [1]
258378
0
National Health & Medical Research Council
GPO Box 1421
Canberra
ACT, 2601
Australia
Query!
Country [1]
258378
0
Australia
Query!
Funding source category [2]
258379
0
Hospital
Query!
Name [2]
258379
0
Sir Charles Gairdner Hospital Research Advisory Council
Query!
Address [2]
258379
0
2nd Floor A Block
Sir Charles Gairdner Hospital
Hospital Ave
Nedlands, WA
6009
Query!
Country [2]
258379
0
Australia
Query!
Funding source category [3]
258380
0
Other Collaborative groups
Query!
Name [3]
258380
0
Australia and New Zealand College of Anaesthetists
Query!
Address [3]
258380
0
ANZCA House
630 St Kilda Rd
Melbourne, VIC
3004
Query!
Country [3]
258380
0
Australia
Query!
Primary sponsor type
Individual
Query!
Name
Professor Peter Eastwood
Query!
Address
Department of Pulmonary Physiology
5th Floor, G Block
Sir Charles Gairdner Hospital
Hospital Ave
Nedlands, WA
6009
Query!
Country
Australia
Query!
Secondary sponsor category [1]
257524
0
Hospital
Query!
Name [1]
257524
0
Sir Charles Gairdner Hospital
Query!
Address [1]
257524
0
Research Governance Unit
2nd Floor, A Block
Hospital Ave
Nedlands, WA
6009
Query!
Country [1]
257524
0
Australia
Query!
Other collaborator category [1]
251783
0
Individual
Query!
Name [1]
251783
0
Clinical Professor David Hillman
Query!
Address [1]
251783
0
Department of Pulmonary Physiology
5th Floor, G Block
Sir Charles Gairdner Hospital
Hospital Ave
Nedlands, WA
6009
Query!
Country [1]
251783
0
Australia
Query!
Other collaborator category [2]
282472
0
Individual
Query!
Name [2]
282472
0
A/Prof Jennifer Walsh
Query!
Address [2]
282472
0
Department of Pulmonary Physiology and Sleep Research,
5th Floor G Block,
Sir Charles Gairdner Hospital,
Hospital Ave,
Nedlands, WA
Australia 6009
Query!
Country [2]
282472
0
Australia
Query!
Ethics approval
Ethics application status
Approved
Query!
Ethics committee name [1]
260355
0
Sir Charles Gairnder Hospital Human Research Ethics Committee
Query!
Ethics committee address [1]
260355
0
2nd Floor, A Block
Sir Charles Gairdner Hospital
Hospital Ave
Nedlands, WA
6009
Query!
Ethics committee country [1]
260355
0
Australia
Query!
Date submitted for ethics approval [1]
260355
0
Query!
Approval date [1]
260355
0
14/05/2009
Query!
Ethics approval number [1]
260355
0
2009-037
Query!
Summary
Brief summary
The aim of the study is to determine the effect of head posture on the collapsibility of the airway during aesthesia and sleep in subjects with and without obstructive sleep apnoea. It is hypothesized that the airway will be more collapsible in the flexed (chin tucked) position than in the neutral or extended position during sleep and anaesthesia.
Query!
Trial website
Nil
Query!
Trial related presentations / publications
1. Maddison K, Ong J, Touyz G, Platt P, Hillman D, Eastwood P, Walsh J. Assessing Upper Airway Collapsibility During Sleep and General Anaesthesia – Comparison of Two Techniques. Sleep and Biological Rhythms Oct 2014; 11 (Suppl 1) p50. ORAL PRESENTATION
2. Maddison KJ, Walsh J, Shepherd K, Platt P, Hillman D and Eastwood P. Comparing Upper Airway Collapsibility During Anaesthesia and NREM Sleep in Patients With and Without OSA. Sleep and Biological Rhythms Oct 2013; 11 (Suppl 2) p73. ORAL POSTER PRESENTATION
8. Maddison KJ, Walsh JH, Shepherd KL, Bharat C, Lawther BK, Platt PR, Eastwood PR, Hillman DR. Comparison of Collapsibility of the Human Upper Airway During Anesthesia and During Sleep. Anesth Analg. 2019 PUBLICATIONS
Query!
Public notes
Query!
Contacts
Principal investigator
Name
32125
0
Prof Peter Eastwood
Query!
Address
32125
0
Department of Pulmonary Physiology and Sleep Research
5th Floor G Block
Sir Charles Gairdner Hospital
Hospital Ave
Nedlands, WA
6009
Query!
Country
32125
0
Australia
Query!
Phone
32125
0
+61 8 6457 2888
Query!
Fax
32125
0
Query!
Email
32125
0
[email protected]
Query!
Contact person for public queries
Name
15372
0
Dr Kathleen Maddison
Query!
Address
15372
0
Department of Pulmonary Physiology
5th Floor G Block
Sir Charles Gairnder Hospital
Hospital Ave
Nedlands, WA
6009
Query!
Country
15372
0
Australia
Query!
Phone
15372
0
+61 8 6457 1192
Query!
Fax
15372
0
Query!
Email
15372
0
[email protected]
Query!
Contact person for scientific queries
Name
6300
0
Dr Professor Peter Eastwood
Query!
Address
6300
0
Department of Pulmonary Physiology
5th Floor G Block
Sir Charles Gairnder Hospital
Hospital Ave
Nedlands, WA
6009
Query!
Country
6300
0
Australia
Query!
Phone
6300
0
+61 8 6457 2888
Query!
Fax
6300
0
Query!
Email
6300
0
[email protected]
Query!
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
Query!
What data in particular will be shared?
Individual participant data underlying published results only - after de-identification
Query!
When will data be available (start and end dates)?
Following publication, ending 7 years following main results publication.
Query!
Available to whom?
Case-by-case basis at the discretion of principal investigator and associated research team, typically provided only researchers who provide a methodologically sound proposal.
Query!
Available for what types of analyses?
Only to achieve the aims in the approved proposal
Query!
How or where can data be obtained?
Access subject to approvals by Principal Investigator (provide email or other contact details). Please contact either Prof Peter Eastwood by email (
[email protected]
) or Dr Kathleen Maddison (
[email protected]
) to request access to the individual data.
Query!
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
Documents added manually
Type
Is Peer Reviewed?
DOI
Citations or Other Details
Attachment
Study results article
Yes
Maddison KJ, Walsh JH, Shepherd KL, Bharat C, Lawt...
[
More Details
]
Documents added automatically
No additional documents have been identified.
Download to PDF