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Trial registered on ANZCTR
Registration number
ACTRN12623001307695
Ethics application status
Approved
Date submitted
9/11/2023
Date registered
15/12/2023
Date last updated
28/07/2024
Date data sharing statement initially provided
15/12/2023
Date results provided
28/07/2024
Type of registration
Prospectively registered
Titles & IDs
Public title
Nasal oscillation device targeting nasal congestion
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Scientific title
A nasal airflow oscillation device targeting relieve nasal congestion
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Secondary ID [1]
310916
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None
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Universal Trial Number (UTN)
U1111-1259-0704
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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:
Nasal congestion
331977
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Condition category
Condition code
Respiratory
328715
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0
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Other respiratory disorders / diseases
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Intervention/exposure
Study type
Interventional
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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.
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Intervention code [1]
327345
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Treatment: Devices
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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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Sinonasal symptoms using a 10-point visual analogue scale (VAS)
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Assessment method [1]
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Subjects will be asked to rate individual nasal symptoms including overall sinonasal symptoms using a 10-point visual analogue scale (VAS), with higher scores generally representing greater symptom burden. However, a higher VAS smell score represents a higher sense of smell. The subject will then asked to wear the device for 20 minutes. The device will then be removed. Patients will re-rate their nasal symptoms using the 10-point VAS.
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Timepoint [1]
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Individual nasal symptoms will be rated before the device is worn and after the device has been worn for 20 minutes.
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Primary outcome [2]
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Peak nasal inspiratory flow
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Assessment method [2]
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Baseline nasal peak inspiratory flows (NPIF) will be performed on each subject. Each patient will be trained on how to perform NPIF. After an initial training run, three runs will be performed, averaged, and recorded in litres/ minute (L/ minute). The subject will then wear the device for 20 minutes. The device will then removed. NPIF will then repeated on three occasions, averaged, and recorded in L/ minute.
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Timepoint [2]
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Peak nasal inspiratory flow will be performed prior to treatment and after the device has been worn for twenty minutes.
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Secondary outcome [1]
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Ease of device use
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Assessment method [1]
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The device will be explained to the subject. At the beginning of the study, the device will be placed and after approximately 1 minute of wearing the device the subject will then asked to rate their initial experience of breathing at rest on a 1-10 scale (10 was easiest) while wearing the device.
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Timepoint [1]
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At beginning of study
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Eligibility
Key inclusion criteria
Adults aged from 18-80 years with a history of chronic nasal congestion for more than one year
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Minimum age
18
Years
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Maximum age
80
Years
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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
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
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Non-randomised trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
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Who is / are masked / blinded?
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Intervention assignment
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Other design features
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Phase
Not Applicable
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Type of endpoint/s
Efficacy
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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.
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Recruitment
Recruitment status
Completed
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Date of first participant enrolment
Anticipated
1/01/2024
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Actual
8/01/2024
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Date of last participant enrolment
Anticipated
20/01/2024
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Actual
1/02/2024
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Date of last data collection
Anticipated
20/01/2024
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Actual
1/02/2024
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Sample size
Target
20
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Accrual to date
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Final
20
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Recruitment outside Australia
Country [1]
25961
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New Zealand
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State/province [1]
25961
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Funding & Sponsors
Funding source category [1]
315178
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Other Collaborative groups
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Name [1]
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Kiwi Innovation Network (Tier 2 Pre-Seed funding grant number AU002176)
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Address [1]
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Manaaki Whenua - Landcare Research Gate 10 Silverdale Road, Hillcrest, Hamilton 3216
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Country [1]
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New Zealand
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Primary sponsor type
Individual
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Name
Jim Bartley
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Address
Department of Otolaryngology - Head and Neck Surgery Manukau Superclinic 901 Great South Road Manukau City Centre Auckland 2104
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Country
New Zealand
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Secondary sponsor category [1]
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None
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Name [1]
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Address [1]
317202
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Country [1]
317202
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
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Central Health and Disability Ethics Committee
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Ethics committee address [1]
314108
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Ministry of Health Health and Disability Ethics Committees PO Box 5013 Wellington 6140
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Ethics committee country [1]
314108
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New Zealand
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Date submitted for ethics approval [1]
314108
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16/12/2020
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Approval date [1]
314108
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18/05/2021
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Ethics approval number [1]
314108
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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.
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Trial website
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Trial related presentations / publications
Nil
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Public notes
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Contacts
Principal investigator
Name
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Dr Jim Bartley
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Address
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Department of Otolaryngology - Head and Neck Surgery Manukau Superclinic 901 Great South Road Manukau City Centre Auckland 2104
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Country
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New Zealand
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Phone
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+64 021 1485077
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Fax
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Email
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[email protected]
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Contact person for public queries
Name
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Jim Bartley
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Address
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Department of Otolaryngology - Head and Neck Surgery Manukau Superclinic 901 Great South Road Manukau City Centre Auckland 2104
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Country
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New Zealand
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Phone
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+64 0211485077
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Fax
130439
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Email
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[email protected]
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Contact person for scientific queries
Name
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Jim Bartley
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Address
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Department of Otolaryngology - Head and Neck Surgery Manukau Superclinic 901 Great South Road Manukau City Centre Auckland 2104
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Country
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New Zealand
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Phone
130440
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+64 0211485077
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Fax
130440
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Email
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[email protected]
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Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
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What data in particular will be shared?
All of the individual data after de-identification
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When will data be available (start and end dates)?
Immediately following publication. The data will be available for 5 years after publication
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Available to whom?
Anyone who wishes to access it
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Available for what types of analyses?
Appropriate statistical analysis
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How or where can data be obtained?
Access available subject to contacting the principal investigator
[email protected]
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What supporting documents are/will be available?
No Supporting Document Provided
Doc. No.
Type
Citation
Link
Email
Other Details
Attachment
20868
Study protocol
The supporting documents can be obtained by contacting
[email protected]
20869
Statistical analysis plan
The statistical analysis plan will be available by contacting
[email protected]
20870
Informed consent form
386845-(Uploaded-09-11-2023-17-20-22)-Study-related document.docx
20871
Clinical study report
386845-(Uploaded-09-11-2023-17-32-04)-Study-related document.docx
20872
Ethical 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.
Download to PDF