Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12624001309572p
Ethics application status
Not yet submitted
Date submitted
9/10/2024
Date registered
29/10/2024
Date last updated
29/10/2024
Date data sharing statement initially provided
29/10/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
Vibration Therapy for Patients with nasal congestion
Scientific title
Investigating the Effects of Acoustic Therapy on the Nasal Microbiome, Immune Responses, and Well-being in Patients with Chronic Rhinosinusitis or Allergic Rhinitis
Secondary ID [1] 313145 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chronic rhinosinusitis 335432 0
Allergic rhinitis 335433 0
Condition category
Condition code
Respiratory 331993 331993 0 0
Other respiratory disorders / diseases
Alternative and Complementary Medicine 331994 331994 0 0
Other alternative and complementary medicine

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The principal aims of the study are to investigate the effects of acoustic therapy using the Goodair Nosebuds on the nasal microbiome, immune markers, and overall well-being in individuals with allergic rhinitis (AR) and chronic rhinosinusitis (CRS). The Goodair Nosebuds is a portable device that participants can insert into their nose to provide acoustic therapy in the form of augmented humming at 130 Hz. In the pre-treatment visit (Clinic Visit 1), participants will be shown how to use the device by a Clinical Investigator with over 20 years experience as an Ear-Nose-Throat surgeon. Participants will then be asked to used the device for 10 minutes, twice daily for about 4 weeks, in their own homes (the intervention). A member of the research team will check in weekly with the participants during this time by email or phone. A self-reported adherence to the intervention will be obtained in the post-treatment visit (Clinic Visit 2) as part of a user-experience questionnaire. As the participants will be able to keep the device, their voluntary continuation with the intervention will also be obtained through the user-experience questionnaire in the Follow up visit (Clinic Visit 3).

Participants will attend three clinic visits: one at the beginning (pre-treatment) and one after using the acoustic therapy device for four weeks (post-treatment), each lasting up to one hour. A follow-up visit will occur several weeks after the main study to assess longer-term effects. There will be no randomisation or blinding, and the study will not include a control group, as comparisons will be made to the pre-treatment datapoint for each individual.
Intervention code [1] 329725 0
Treatment: Devices
Comparator / control treatment
Changes post-treatment and the subsequent follow-up will be compared to the pre-treatment datapoint for each individual.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 339593 0
Nasal microbial community structure
Timepoint [1] 339593 0
Pre-treatment with post-treatment (4 weeks of treatment) and follow-up at approximately 4 weeks after treatment
Primary outcome [2] 339594 0
Levels of pro-inflammatary and anti-inflammatory markers in blood serum as a composite
Timepoint [2] 339594 0
Pre-treatment with post-treatment (4 weeks of treatment) and follow-up at approximately 4 weeks after treatment
Primary outcome [3] 339595 0
Sino-Nasal Outcome Test (SNOT-22) questionnaire
Timepoint [3] 339595 0
Pre-treatment with post-treatment (4 weeks of treatment) and follow-up at approximately 4 weeks after treatment
Secondary outcome [1] 440541 0
User experience of the acoustic therapy device
Timepoint [1] 440541 0
Post-treatment (after 4 weeks of treatment) and follow-up at approximately 4 weeks after treatment

Eligibility
Key inclusion criteria
1. Aged between 18 to 80 years old
2. Symptoms of CRS or AR
3. Non-smoker
Minimum age
18 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Fixed structural cause of nasal congestion
2. Current nasal crusting or ulceration on rhinoscopy
3. History of severe nose bleeding within last 3 months
4. Anticoagulation use (acetylsalicylic acid allowed),
5. Known pregnancy
6. Allergic sensitivity to silicone or any other component of device
7. Inability to read and understand English
8. Inability to perform treatment due to underlying medical condition.
9. Nasal swab taken within the past seven days- clinic visits can be re-scheduled for a later date.
10. History of immune disorders or chronic inflammatory diseases other than CRS or AR.

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
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
13/01/2025
Actual
Date of last participant enrolment
Anticipated
30/06/2025
Actual
Date of last data collection
Anticipated
30/09/2025
Actual
Sample size
Target
30
Accrual to date
Final
Recruitment outside Australia
Country [1] 26628 0
New Zealand
State/province [1] 26628 0

Funding & Sponsors
Funding source category [1] 317589 0
University
Name [1] 317589 0
Auckland University of Technology: Performance Based Research Fund
Country [1] 317589 0
New Zealand
Primary sponsor type
University
Name
Auckland University of Technology
Address
Country
New Zealand
Secondary sponsor category [1] 319892 0
None
Name [1] 319892 0
Address [1] 319892 0
Country [1] 319892 0

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 316292 0
Southern Health and Disability Ethics Committee
Ethics committee address [1] 316292 0
Ethics committee country [1] 316292 0
New Zealand
Date submitted for ethics approval [1] 316292 0
31/10/2024
Approval date [1] 316292 0
Ethics approval number [1] 316292 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 137422 0
Dr Kelvin Lau
Address 137422 0
Auckland University of Technology, 90 Akoranga Drive, Northcote, Auckland 0627
Country 137422 0
New Zealand
Phone 137422 0
+64 9 921 9666
Fax 137422 0
Email 137422 0
[email protected]
Contact person for public queries
Name 137423 0
Kelvin Lau
Address 137423 0
Auckland University of Technology, 90 Akoranga Drive, Northcote, Auckland 0627
Country 137423 0
New Zealand
Phone 137423 0
+64 9 921 9666
Fax 137423 0
Email 137423 0
[email protected]
Contact person for scientific queries
Name 137424 0
Kelvin Lau
Address 137424 0
Auckland University of Technology, 90 Akoranga Drive, Northcote, Auckland 0627
Country 137424 0
New Zealand
Phone 137424 0
+64 9 921 9666
Fax 137424 0
Email 137424 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
Data relating to individual participants will be de-identified during the analysis. Only summarised data, where information for individuals is not identifiable, will be made publically available.


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.