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Trial registered on ANZCTR
Registration number
ACTRN12620000752965
Ethics application status
Approved
Date submitted
10/06/2020
Date registered
21/07/2020
Date last updated
21/07/2020
Date data sharing statement initially provided
21/07/2020
Type of registration
Prospectively registered
Titles & IDs
Public title
Uvulopalatopharyngolasty: does the specific surgical technique improve post-operative apnoea hypoxia index?
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Scientific title
Uvulopalatopharyngolasty: does the specific surgical technique improve post-operative apnoea hypoxia index?
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Secondary ID [1]
301477
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None
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Sleep apnoea
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Condition category
Condition code
Surgery
315862
315862
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0
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Surgical techniques
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Respiratory
316033
316033
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0
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Sleep apnoea
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Intervention/exposure
Study type
Observational
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Patient registry
False
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Target follow-up duration
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Target follow-up type
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Description of intervention(s) / exposure
This study aims to prospectively demonstrate subjective and objective changes in sleep disturbance due to surgical uvulopalatopharyngoplasty. We aim to observe changes in subjective symptoms (via the Epworth Sleepiness Scale and Functional Outcomes of Sleep Questionnaire) and objective apnoea hyponoea index measurement both pre- and post-operatively. These observations will be made pre-operatively and at three months post-operatively.
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Intervention code [1]
317789
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Not applicable
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Comparator / control treatment
No control group
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Control group
Uncontrolled
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Outcomes
Primary outcome [1]
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Apnoea hypopnoea index
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Assessment method [1]
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Timepoint [1]
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Pre-operatively and three months post-operatively
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Secondary outcome [1]
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Epworth Sleepiness Scale
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Assessment method [1]
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Timepoint [1]
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Pre-operatively and three months post-operatively
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Secondary outcome [2]
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Functional Outcomes of Sleep Questionnaire
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Assessment method [2]
383680
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Timepoint [2]
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Pre-operatively and three months post-operatively
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Eligibility
Key inclusion criteria
Patients undergoing uvulopalatopharyngoplasty with Mr Gerard Fogarty
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
Children, patients who are not competent to consent
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Study design
Purpose
Natural history
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Duration
Longitudinal
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Selection
Defined population
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Timing
Prospective
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Statistical methods / analysis
Mr Fogarty performs about 15 -20 of these procedures per year and this study aims to recruit at least 20 participants over a 12 month period.
SPSS program will be used to analyse the relationship of undergoing UPPP to pre- and post-operative AHI results and questionnaire reponses.
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Recruitment
Recruitment status
Not yet recruiting
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Date of first participant enrolment
Anticipated
3/08/2020
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Actual
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Date of last participant enrolment
Anticipated
2/08/2021
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Actual
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Date of last data collection
Anticipated
31/12/2021
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Actual
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Sample size
Target
20
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
NSW,VIC
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Recruitment hospital [1]
16855
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Albury Wodonga Health - Albury campus - Albury
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Recruitment hospital [2]
16856
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Albury Wodonga Health - Wodonga campus - Wodonga
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Recruitment postcode(s) [1]
30500
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2640 - Albury
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Recruitment postcode(s) [2]
30501
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3690 - Wodonga
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Funding & Sponsors
Funding source category [1]
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Self funded/Unfunded
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Name [1]
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Unfunded
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Address [1]
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Unfunded
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Country [1]
305916
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Primary sponsor type
Individual
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Name
Mr Gerard Fogarty
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Address
Albury ENT
450 Swift Street,
ALBURY, NSW, 2640
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Country
Australia
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Secondary sponsor category [1]
306369
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None
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Name [1]
306369
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-
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Address [1]
306369
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-
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Country [1]
306369
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
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Albury-Wodonga Ethics Committee
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Ethics committee address [1]
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Albury-Wodonga Health Borella Road ALBURY, NSW, 2640
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Ethics committee country [1]
306165
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Australia
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Date submitted for ethics approval [1]
306165
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10/06/2020
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Approval date [1]
306165
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08/07/2020
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Ethics approval number [1]
306165
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EMR/65592 456/20/6
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Summary
Brief summary
Aims: This is a prospective cohort study with a primary aim to determine whether Mr Fogarty’s UPPP technique results in improved post-operative AHIs. Secondary aims include analysis of participants’ pre- and post-operative experience of sleep disordered breathing, Research activities: The research participants will be asked to undergo both pre-operative and three months post-operative sleep studies through the Albury Wodonga Private Hospital. Patients will also be asked to complete the Epworth Sleepiness Scale and Functional Outcomes of Sleep Questionnaire (FOSQ-10) both pre-operatively and at three months post-operatively. No other participant follow-up will be required beyond the usual surgical post-operative practice.
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Dr Olivia Nicholson
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Address
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Albury Base Hospital Borella Road Albury, NSW, 2640
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Country
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Australia
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Phone
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+61 260584444
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Fax
102938
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Email
102938
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olivia.nicholson.29@gmail.com
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Contact person for public queries
Name
102939
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Olivia Nicholson
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Address
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Albury Base Hospital Borella Road Albury, NSW, 2640
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Country
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Australia
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Phone
102939
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+61 260584444
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Fax
102939
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Email
102939
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olivia.nicholson.29@gmail.com
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Contact person for scientific queries
Name
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Olivia Nicholson
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Address
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Albury Base Hospital Borella Road Albury, NSW, 2640
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Country
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Australia
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Phone
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+61 260584444
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Fax
102940
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Email
102940
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olivia.nicholson.29@gmail.com
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Data sharing statement
Will the study consider sharing individual participant data?
No
No IPD sharing reason/comment:
Privacy of participants
What supporting documents are/will be available?
No Supporting Document Provided
Type
Citation
Link
Email
Other Details
Attachment
Study protocol
Study-related document.docx
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.
Download to PDF