Trial Review

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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?
Scientific title
Uvulopalatopharyngolasty: does the specific surgical technique improve post-operative apnoea hypoxia index?
Secondary ID [1] 301477 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Sleep apnoea 317801 0
Condition category
Condition code
Surgery 315862 315862 0 0
Surgical techniques
Respiratory 316033 316033 0 0
Sleep apnoea

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
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.
Intervention code [1] 317789 0
Not applicable
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 324072 0
Apnoea hypopnoea index
Timepoint [1] 324072 0
Pre-operatively and three months post-operatively
Secondary outcome [1] 383679 0
Epworth Sleepiness Scale
Timepoint [1] 383679 0
Pre-operatively and three months post-operatively
Secondary outcome [2] 383680 0
Functional Outcomes of Sleep Questionnaire
Timepoint [2] 383680 0
Pre-operatively and three months post-operatively

Eligibility
Key inclusion criteria
Patients undergoing uvulopalatopharyngoplasty with Mr Gerard Fogarty
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Children, patients who are not competent to consent

Study design
Purpose
Natural history
Duration
Longitudinal
Selection
Defined population
Timing
Prospective
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.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
3/08/2020
Actual
Date of last participant enrolment
Anticipated
2/08/2021
Actual
Date of last data collection
Anticipated
31/12/2021
Actual
Sample size
Target
20
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,VIC
Recruitment hospital [1] 16855 0
Albury Wodonga Health - Albury campus - Albury
Recruitment hospital [2] 16856 0
Albury Wodonga Health - Wodonga campus - Wodonga
Recruitment postcode(s) [1] 30500 0
2640 - Albury
Recruitment postcode(s) [2] 30501 0
3690 - Wodonga

Funding & Sponsors
Funding source category [1] 305916 0
Self funded/Unfunded
Name [1] 305916 0
Unfunded
Country [1] 305916 0
Primary sponsor type
Individual
Name
Mr Gerard Fogarty
Address
Albury ENT
450 Swift Street,
ALBURY, NSW, 2640
Country
Australia
Secondary sponsor category [1] 306369 0
None
Name [1] 306369 0
-
Address [1] 306369 0
-
Country [1] 306369 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 306165 0
Albury-Wodonga Ethics Committee
Ethics committee address [1] 306165 0
Albury-Wodonga Health
Borella Road
ALBURY, NSW, 2640
Ethics committee country [1] 306165 0
Australia
Date submitted for ethics approval [1] 306165 0
10/06/2020
Approval date [1] 306165 0
08/07/2020
Ethics approval number [1] 306165 0
EMR/65592 456/20/6

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.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 102938 0
Dr Olivia Nicholson
Address 102938 0
Albury Base Hospital
Borella Road
Albury, NSW, 2640
Country 102938 0
Australia
Phone 102938 0
+61 260584444
Fax 102938 0
Email 102938 0
olivia.nicholson.29@gmail.com
Contact person for public queries
Name 102939 0
Dr Olivia Nicholson
Address 102939 0
Albury Base Hospital
Borella Road
Albury, NSW, 2640
Country 102939 0
Australia
Phone 102939 0
+61 260584444
Fax 102939 0
Email 102939 0
olivia.nicholson.29@gmail.com
Contact person for scientific queries
Name 102940 0
Dr Olivia Nicholson
Address 102940 0
Albury Base Hospital
Borella Road
Albury, NSW, 2640
Country 102940 0
Australia
Phone 102940 0
+61 260584444
Fax 102940 0
Email 102940 0
olivia.nicholson.29@gmail.com

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Privacy of participants


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
8193Study protocol    379970-(Uploaded-10-06-2020-09-38-24)-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.