Trial Review

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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12623001307695
Ethics application status
Approved
Date submitted
9/11/2023
Date registered
15/12/2023
Date last updated
15/12/2023
Date data sharing statement initially provided
15/12/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
Nasal oscillation device targeting nasal congestion
Scientific title
A nasal airflow oscillation device targeting relieve nasal congestion
Secondary ID [1] 310916 0
None
Universal Trial Number (UTN)
U1111-1259-0704
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Nasal congestion 331977 0
Condition category
Condition code
Respiratory 328715 328715 0 0
Other respiratory disorders / diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
A small nasal airflow oscillation device that plugs into the nose to create nasal pressure oscillations at 130 Hz has been developed. The purpose of this study is to assess the acceptability, safety, and possible efficacy of this small nasal airflow oscillation device in subjects suffering nasal congestion. The subject will be asked to wear the device in their nose on one occasion for 20 minutes. Participants will be asked to sit down quietly for twenty minutes. The participants will be monitored by research staff on a regular basis.
Intervention code [1] 327345 0
Treatment: Devices
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 336521 0
Sinonasal symptoms using a 10-point visual analogue scale (VAS)
Timepoint [1] 336521 0
Individual nasal symptoms will be rated before the device is worn and after the device has been worn for 20 minutes.
Primary outcome [2] 336544 0
Peak nasal inspiratory flow
Timepoint [2] 336544 0
Peak nasal inspiratory flow will be performed prior to treatment and after the device has been worn for twenty minutes.
Secondary outcome [1] 428749 0
Ease of device use
Timepoint [1] 428749 0
At beginning of study

Eligibility
Key inclusion criteria
Adults aged from 18-80 years with a history of chronic nasal congestion for more than one year
Minimum age
18 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Cigarette smoking, a fixed structural cause of nasal congestion (moderate or severe septal deviation), moderate or severe nasal valve collapse, Grade 2-4 polyps, recent upper respiratory illness, nasal decongestant use within the last week, nasal crusting or ulceration on rhinoscopy, a history of severe nose bleeding within the last 3 months, anticoagulant use, known pregnancy, allergic sensitivity to silicone or any other component of device, and inability to read and understand English

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)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Data will be analysed for within subject differences using basic statistical tests of relationship and difference using two-sided t-tests. A value of p < 0.05 will be considered statistically significant.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/01/2024
Actual
Date of last participant enrolment
Anticipated
20/01/2024
Actual
Date of last data collection
Anticipated
20/01/2024
Actual
Sample size
Target
20
Accrual to date
Final
Recruitment outside Australia
Country [1] 25961 0
New Zealand
State/province [1] 25961 0

Funding & Sponsors
Funding source category [1] 315178 0
Other Collaborative groups
Name [1] 315178 0
Kiwi Innovation Network (Tier 2 Pre-Seed funding grant number AU002176)
Country [1] 315178 0
New Zealand
Primary sponsor type
Individual
Name
Jim Bartley
Address
Department of Otolaryngology - Head and Neck Surgery Manukau Superclinic 901 Great South Road Manukau City Centre Auckland 2104
Country
New Zealand
Secondary sponsor category [1] 317202 0
None
Name [1] 317202 0
Address [1] 317202 0
Country [1] 317202 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 314108 0
Central Health and Disability Ethics Committee
Ethics committee address [1] 314108 0
Ministry of Health Health and Disability Ethics Committees PO Box 5013 Wellington 6140
Ethics committee country [1] 314108 0
New Zealand
Date submitted for ethics approval [1] 314108 0
16/12/2020
Approval date [1] 314108 0
18/05/2021
Ethics approval number [1] 314108 0

Summary
Brief summary
Upper respiratory tract complaints are common in the general population. A safe, non-pharmacologic treatment would be an attractive option for many patients either as an alternative to existing therapies, or as a complementary therapy. This study assesses the acceptability, safety and possible efficacy of a nasal airflow oscillation device in a group of people suffering chronic nasal congestion.
Trial website
Trial related presentations / publications
Nil
Public notes

Contacts
Principal investigator
Name 130438 0
Dr Jim Bartley
Address 130438 0
Department of Otolaryngology - Head and Neck Surgery Manukau Superclinic 901 Great South Road Manukau City Centre Auckland 2104
Country 130438 0
New Zealand
Phone 130438 0
+64 021 1485077
Fax 130438 0
Email 130438 0
jimbartley56@gmail.com
Contact person for public queries
Name 130439 0
Dr Jim Bartley
Address 130439 0
Department of Otolaryngology - Head and Neck Surgery Manukau Superclinic 901 Great South Road Manukau City Centre Auckland 2104
Country 130439 0
New Zealand
Phone 130439 0
+64 0211485077
Fax 130439 0
Email 130439 0
jimbartley56@gmail.com
Contact person for scientific queries
Name 130440 0
Dr Jim Bartley
Address 130440 0
Department of Otolaryngology - Head and Neck Surgery Manukau Superclinic 901 Great South Road Manukau City Centre Auckland 2104
Country 130440 0
New Zealand
Phone 130440 0
+64 0211485077
Fax 130440 0
Email 130440 0
jimbartley56@gmail.com

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
All of the individual data after de-identification
When will data be available (start and end dates)?
Immediately following publication. The data will be available for 5 years after publication
Available to whom?
Anyone who wishes to access it
Available for what types of analyses?
Appropriate statistical analysis
How or where can data be obtained?
Access available subject to contacting the principal investigator jimbartley56@gmail.com


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
20868Study protocolThe supporting documents can be obtained by contacting jimbartley56@gmail.com  
20869Statistical analysis planThe statistical analysis plan will be available by contacting jimbartley56@gmail.com  
20870Informed consent form    386845-(Uploaded-09-11-2023-17-20-22)-Study-related document.docx
20871Clinical study report    386845-(Uploaded-09-11-2023-17-32-04)-Study-related document.docx
20872Ethical approval    386845-(Uploaded-09-11-2023-17-33-14)-Study-related document.pdf



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.