Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12609000087257
Ethics application status
Not yet submitted
Date submitted
10/12/2008
Date registered
9/02/2009
Date last updated
9/02/2009
Type of registration
Retrospectively registered

Titles & IDs
Public title
Determining which throat muscles are important in obstructive sleep apnoea
Scientific title
Upper airway muscle function during wakefulness and sleep in individuals with and without obstructive sleep apnoea
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Obstructive sleep apnoea 4117 0
Condition category
Condition code
Respiratory 4310 4310 0 0
Sleep apnoea

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Each participant will have two small catheters inserted into the upper airway (throat) and oesophagus via the nose. Fine wire electrodes will be inserted into the genioglossus, geniohyoid, tensor palatini and levator palatini muscles. The catheters and wires will be inserted in the late afternoon and remain in place until the following morning (approximately 15 hours total). These wires and catheters will allow measurement of the activity of the upper airway muscles during wakefulness and sleep to determine which muscles are important in maintaining an open airway and how they may be failing to allow upper airway collapse in patients with sleep apnoea.
Intervention code [1] 3826 0
Not applicable
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 5201 0
Comparisons of the activity of the upper airway muscles between individuals with and without obstructive sleep apnoea. Upper airway muscle activity will be measured using intramuscular electromyography ( fine wires will be inserted into each muscle). The amount of activity recorded will be compared between groups.
Timepoint [1] 5201 0
Overall, the study will run for 12 months. Comparisons of upper airway activity will be made between groups as soon as data collection in all subjects is complete, which is likely to be at approximately 12 months, although may occur sooner.
Secondary outcome [1] 8754 0
Comparisons of catheter-based measurements of upper airway muscle activity with fine-wire measurements of upper airway muscle activity
Timepoint [1] 8754 0
Overall, the study will run for 12 months. Comparisons of upper airway activity will be made between the fine wires and the catheter measurements of muscle activity as soon as data collection in all subjects is complete, which is likely to be at approximately 12 months, although may occur sooner.

Eligibility
Key inclusion criteria
Age >18yrs
Without uncontrolled hypertension, without type 1 diabetes or uncontrolled type II diabetes, without cardiovascular disease.
Healthy individual or diagnosis of obstructive sleep apnoea
Minimum age
18 Years
Maximum age
70 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Age <18 years
Uncontrolled hypertension
type 1 diabetes
uncontrolled type II diabetes
cardiovascular disease

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

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/02/2009
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
30
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 4277 0
Government body
Name [1] 4277 0
National Health and Medical Research Council Project Grant No. 572647
Country [1] 4277 0
Australia
Primary sponsor type
Hospital
Name
Sir Charles Gairdner Hospital
Address
Hospital Avenue Nedlands
Perth 6009
Western Australia
Country
Australia
Secondary sponsor category [1] 3849 0
None
Name [1] 3849 0
Address [1] 3849 0
Country [1] 3849 0

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 6330 0
Sir Charles Gairdner Hospital Human Research Ethics Committee
Ethics committee address [1] 6330 0
Human Research Ethics Committee
Level 1 E-Block
Sir Charles Gairdner Hospital
Hospital Avenue
Nedlands Perth 6009
Western Australia
Ethics committee country [1] 6330 0
Australia
Date submitted for ethics approval [1] 6330 0
25/11/2008
Approval date [1] 6330 0
08/01/2009
Ethics approval number [1] 6330 0
2008-175

Summary
Brief summary
Obstructive sleep apnoea is a common and treatable condition characterised by upper airway (throat) collapse which results in the repeated cessation of breathing during sleep. It is associated with disrupted sleep and excessive daytime tiredness and lethargy, which have major consequences for social well-being and productivity in our community. It is association with hypertension and is an independent risk factor for cardiovascular disease.

Upper airway muscle activity is important in the pathogenesis of obstructive sleep apnoea, both in the development of upper airway collapse and in the restoration of an open airway. The gold standard method of measuring muscle activity by the use of intramuscular electrodes. This technique while relatively painless is invasive as the skin must be punctured. A catheter based technique may allow non-invasive measurement of muscle activity without puncturing the skin. The purpose of this study is to (i) compare the effectiveness of intramuscular recordings of muscle activity with catheter-based recordings of muscle activity and (ii)to determine the role of the upper airway muscles (specifically the genioglossus, geniohyoid, tensor palatini and levator palatini) in maintaining an open airway with inspiratory loading (i.e. increased effort to breathe) during wakefulness and sleep in normal, healthy individuals and individuals with sleep apnoea.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 35031 0
Address 35031 0
Country 35031 0
Phone 35031 0
Fax 35031 0
Email 35031 0
Contact person for public queries
Name 12378 0
Associate Professor Peter Eastwood
Address 12378 0
Department of Pulmonary Physiology
Level 5-G Block
Sir Charles Gairdner Hospital
Perth WA
Country 12378 0
Australia
Phone 12378 0
+61 8 9346 2888
Fax 12378 0
Email 12378 0
[email protected]
Contact person for scientific queries
Name 3306 0
Associate Professor Peter Eastwood
Address 3306 0
Department of Pulmonary Physiology
Level 5-G Block
Sir Charles Gairdner Hospital
Perth WA
Country 3306 0
Australia
Phone 3306 0
+61 8 9346 2888
Fax 3306 0
Email 3306 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
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