Trial Review

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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
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
Secondary ID [1] 253461 0
Sir Charles Gairdner Human Research Ethics Number: 2009-037
Universal Trial Number (UTN)
U1111-1119-2057
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Obstructive Sleep Apnoea 261014 0
Condition category
Condition code
Respiratory 259151 259151 0 0
Sleep apnoea

Intervention/exposure
Study type
Interventional
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.
Intervention code [1] 257904 0
Treatment: Devices
Comparator / control treatment
Neutral head posture
Control group
Active

Outcomes
Primary outcome [1] 262003 0
Upper airway collapsibility as measured by pharyngeal critical closing pressure
Timepoint [1] 262003 0
During sleep and anaesthesia under each head/neck posture condition i.e. in the neutral, flexed and extended posture.
Secondary outcome [1] 268933 0
Nil
Timepoint [1] 268933 0
Nil

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
Minimum age
20 Years
Maximum age
70 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
7/12/2010
Actual
9/12/2010
Date of last participant enrolment
Anticipated
Actual
30/12/2013
Date of last data collection
Anticipated
Actual
30/12/2013
Sample size
Target
17
Accrual to date
Final
31
Recruitment in Australia
Recruitment state(s)
WA
Recruitment hospital [1] 23497 0
Sir Charles Gairdner Hospital - Nedlands
Recruitment postcode(s) [1] 38903 0
6009 - Nedlands

Funding & Sponsors
Funding source category [1] 258378 0
Government body
Name [1] 258378 0
National Health & Medical Research Council
Country [1] 258378 0
Australia
Funding source category [2] 258379 0
Hospital
Name [2] 258379 0
Sir Charles Gairdner Hospital Research Advisory Council
Country [2] 258379 0
Australia
Funding source category [3] 258380 0
Other Collaborative groups
Name [3] 258380 0
Australia and New Zealand College of Anaesthetists
Country [3] 258380 0
Australia
Primary sponsor type
Individual
Name
Professor Peter Eastwood
Address
Department of Pulmonary Physiology
5th Floor, G Block
Sir Charles Gairdner Hospital
Hospital Ave
Nedlands, WA
6009
Country
Australia
Secondary sponsor category [1] 257524 0
Hospital
Name [1] 257524 0
Sir Charles Gairdner Hospital
Address [1] 257524 0
Research Governance Unit
2nd Floor, A Block
Hospital Ave
Nedlands, WA
6009
Country [1] 257524 0
Australia
Other collaborator category [1] 251783 0
Individual
Name [1] 251783 0
Clinical Professor David Hillman
Address [1] 251783 0
Department of Pulmonary Physiology
5th Floor, G Block
Sir Charles Gairdner Hospital
Hospital Ave
Nedlands, WA
6009
Country [1] 251783 0
Australia
Other collaborator category [2] 282472 0
Individual
Name [2] 282472 0
A/Prof Jennifer Walsh
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
Country [2] 282472 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 260355 0
Sir Charles Gairnder Hospital Human Research Ethics Committee
Ethics committee address [1] 260355 0
2nd Floor, A Block
Sir Charles Gairdner Hospital
Hospital Ave
Nedlands, WA
6009
Ethics committee country [1] 260355 0
Australia
Date submitted for ethics approval [1] 260355 0
Approval date [1] 260355 0
14/05/2009
Ethics approval number [1] 260355 0
2009-037

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.
Trial website
Nil
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
Public notes

Contacts
Principal investigator
Name 32125 0
Prof Peter Eastwood
Address 32125 0
Department of Pulmonary Physiology and Sleep Research
5th Floor G Block
Sir Charles Gairdner Hospital
Hospital Ave
Nedlands, WA
6009
Country 32125 0
Australia
Phone 32125 0
+61 8 6457 2888
Fax 32125 0
Email 32125 0
[email protected]
Contact person for public queries
Name 15372 0
Kathleen Maddison
Address 15372 0
Department of Pulmonary Physiology
5th Floor G Block
Sir Charles Gairnder Hospital
Hospital Ave
Nedlands, WA
6009
Country 15372 0
Australia
Phone 15372 0
+61 8 6457 1192
Fax 15372 0
Email 15372 0
[email protected]
Contact person for scientific queries
Name 6300 0
Professor Peter Eastwood
Address 6300 0
Department of Pulmonary Physiology
5th Floor G Block
Sir Charles Gairnder Hospital
Hospital Ave
Nedlands, WA
6009
Country 6300 0
Australia
Phone 6300 0
+61 8 6457 2888
Fax 6300 0
Email 6300 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Individual participant data underlying published results only - after de-identification
When will data be available (start and end dates)?
Following publication, ending 7 years following main results publication.
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.
Available for what types of analyses?
Only to achieve the aims in the approved proposal
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.


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
TypeIs Peer Reviewed?DOICitations or Other DetailsAttachment
Study results articleYes Maddison KJ, Walsh JH, Shepherd KL, Bharat C, Lawt... [More Details]

Documents added automatically
No additional documents have been identified.