Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621000949886
Ethics application status
Approved
Date submitted
9/11/2020
Date registered
20/07/2021
Date last updated
20/07/2021
Date data sharing statement initially provided
20/07/2021
Type of registration
Retrospectively registered

Titles & IDs
Public title
A non-invasive treatment for Otitis Media with Effusion
Scientific title
Usability trial of a non-invasive treatment for Otitis Media with Effusion
Secondary ID [1] 302719 0
Nil known
Universal Trial Number (UTN)
U1111-1260-9526
Trial acronym
NITOME
Linked study record
N/A

Health condition
Health condition(s) or problem(s) studied:
otitis media with effusion (OME) 319662 0
Condition category
Condition code
Ear 317590 317590 0 0
Other ear disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
In a single session, lasting approximately 15 minutes in total, the investigator will assist the child in using an eustachian tube insufflation device that creates controlled nasal pressurisation during swallowing with up to 10 pressurisations.

The Eustachian tube insufflation device is in the form of a sippy cup that a young child can drink from, but with a nasal interface connected to an automated pressurisation element. When the child is drinking from the bottle and align their nose correctly over the air hole on the device, air pressure is applied in the nasal cavity. This pressurisation of the nasal cavity can open the Eustachian tube and reduce negative middle ear pressure.
Investigator will observe the child to see whether they are using the device correctly, through assessment of successful drinking from the cup and correct alignment of the nose on the nasal area on the device. The investigator may need to help the child align their mouth and nose correctly at the beginning to teach the child how to use the device.

The purpose-built app connected to the device will record the nasal pressure and number of successful pressurisations while the child drinks approximately 300 mL from the sippy cup. The investigator will record incorrect use of the device and assist the child in using the device correctly. Whether assistance is required will also be recorded.
Intervention code [1] 319012 0
Treatment: Devices
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 325637 0
Tympanogram assessment: Tympanogram assessment will be conducted before and after each treatment session to detect any change in the middle ear pressure to confirm if the eustachian tubes have been successfully opened and ear pressure equilibrium has been restored.
Timepoint [1] 325637 0
Immediately after treatment
Secondary outcome [1] 388630 0
Otoscopic evaluation: If the patient has a middle ear effusion (observed through routine examination with an otoscope) before the treatment session, the otoscopic evaluation will be used to determine whether after using the device the effusion has been removed.
Timepoint [1] 388630 0
Immediately after treatment

Eligibility
Key inclusion criteria
• Full understanding of the protocol and signed informed consent by the legal guardian
• Able to drink from the bottle appropriately without fear of the device.
• Parent English speaking
• Type C tympanogram
Minimum age
2 Years
Maximum age
12 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
• Nasal congestion
• VPI (Velo-palatal incompetence/velopharyngeal insufficiency)
• A history aspiration or known swallowing dysfunction
• The presence of craniofacial abnormalities
• Other contraindications for positive nasal pressurization
• Active acute respiratory infection
• Active acute otitis media

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



Intervention assignment
Single group
Other design features
None
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Pilot study to determine usability and preliminary effectiveness at opening the Eustachian Tube.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
14/07/2021
Date of last participant enrolment
Anticipated
1/12/2021
Actual
Date of last data collection
Anticipated
1/12/2021
Actual
Sample size
Target
25
Accrual to date
5
Final
Recruitment in Australia
Recruitment state(s)
WA
Recruitment outside Australia
Country [1] 23937 0
United States of America
State/province [1] 23937 0
California

Funding & Sponsors
Funding source category [1] 307147 0
University
Name [1] 307147 0
Stanford University
Country [1] 307147 0
United States of America
Primary sponsor type
University
Name
Curtin University
Address
Kent St, Bentley WA 6102
Country
Australia
Secondary sponsor category [1] 307757 0
University
Name [1] 307757 0
Stanford University
Address [1] 307757 0
Serra Mall, Stanford, CA 94305, United States
Country [1] 307757 0
United States of America

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 307271 0
Curtin University Human Research Ethics Committee (HREC)
Ethics committee address [1] 307271 0
Kent St, Bentley WA 6102
Ethics committee country [1] 307271 0
Australia
Date submitted for ethics approval [1] 307271 0
14/09/2020
Approval date [1] 307271 0
22/09/2020
Ethics approval number [1] 307271 0
HRE2020-0526

Summary
Brief summary
We aim to establish the usability and effectiveness of a new insufflation device, as a way to open the Eustachain Tube and drain the middle ear fluid in children with chronic otitis media with effusion (OME).
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 106602 0
Dr Matt Oldakowski
Address 106602 0
Curtin University
Kent St, Bentley WA 6102
Country 106602 0
Australia
Phone 106602 0
+61 431939585
Fax 106602 0
Email 106602 0
[email protected]
Contact person for public queries
Name 106603 0
Dr Matt Oldakowski
Address 106603 0
Curtin University
Kent St, Bentley WA 6102
Country 106603 0
Australia
Phone 106603 0
+61 431939585
Fax 106603 0
Email 106603 0
[email protected]
Contact person for scientific queries
Name 106604 0
Dr Matt Oldakowski
Address 106604 0
Curtin University
Kent St, Bentley WA 6102
Country 106604 0
Australia
Phone 106604 0
+61 431939585
Fax 106604 0
Email 106604 0
[email protected]

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


What supporting documents are/will be available?

No Supporting Document Provided



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.