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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
28/01/2011
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 72 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, sedation 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 70 kilograms per meters squared
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 70 kilograms per meters squared
Normal lung function
Epworth Sleepiness Score greater than 9
Minimum age
20 Years
Maximum age
70 Years
Gender
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
Recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 258378 0
Government body
Name [1] 258378 0
National Health & Medical Research Council
Address [1] 258378 0
National Health & Medical Research Council
GPO Box 1421
Canberra
ACT, 2601
Australia
Country [1] 258378 0
Australia
Funding source category [2] 258379 0
Hospital
Name [2] 258379 0
Sir Charles Gairdner Hospital Research Advisory Council
Address [2] 258379 0
2nd Floor A Block
Sir Charles Gairdner Hospital
Hospital Ave
Nedlands, WA
6009
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
Address [3] 258380 0
ANZCA House
630 St Kilda Rd
Melbourne, VIC
3004
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

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 sedation, andaesthesia 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, sedation and anaesthesia.
Trial website
Nil
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 32125 0
Address 32125 0
Country 32125 0
Phone 32125 0
Fax 32125 0
Email 32125 0
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 93461192
Fax 15372 0
Email 15372 0
kath.maddison@health.wa.gov.au
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 93461706
Fax 6300 0
Email 6300 0
Peter.Eastwood@health.wa.gov.au

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