Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12625000951459
Ethics application status
Approved
Date submitted
4/08/2025
Date registered
29/08/2025
Date last updated
29/08/2025
Date data sharing statement initially provided
29/08/2025
Type of registration
Retrospectively registered

Titles & IDs
Public title
Pilot Investigation of the Effects of using an augmented breathing device on stress, anxiety, depression, and sleep
Scientific title
Pilot Investigation of the Effects of an Augmented Breathing Device in Individuals with Self-Reported Mild or Moderate Stress, Anxiety, Depression, and Sleep Problems
Secondary ID [1] 313914 0
None
Universal Trial Number (UTN)
U1111-1313-7678
Trial acronym
Linked study record
ACTRN12624001376538

This study is the sub study (pilot study) part of main study registered (ACTRN12624001376538)

Health condition
Health condition(s) or problem(s) studied:
Mild to moderate sleep problems 338424 0
Mild to moderate stress and anxiety 338425 0
Mild to moderate depression 338426 0
Condition category
Condition code
Respiratory 334726 334726 0 0
Other respiratory disorders / diseases
Mental Health 334727 334727 0 0
Anxiety
Mental Health 334728 334728 0 0
Depression
Neurological 334729 334729 0 0
Studies of the normal brain and nervous system

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Device: Goodair Nosebuds – a small, wearable device that fits onto the nose and delivers mechanostimulation to the nasal airway mucosa during breathing.

Modes of Operation:
For this study, only one active mode will be used:

Breeze Mode: Delivers non-lateralized humming stimulation to both nasal passages without airflow regulation. This mode is designed to support decongestion and relaxation by gently vibrating both sides of the nose simultaneously.


Intervention Protocol:

Duration: 2 weeks

Frequency: Participants will use the device twice daily, 12 minutes per session

Total Number of Participants: 16

Group Assignment:

Active Group (n = 8): Uses the Breeze Mode Nosebuds

Sham Group (n = 8): Uses the non-stimulating sham device

Usage Instructions:

Timing: Participants may choose when to use the device each day; no strict schedule is imposed.

Posture: Device may be used while sitting or lying down; participants are encouraged to be in a comfortable position.

Adherence Monitoring: Participants will maintain a daily usage log (self-reported diary) to monitor compliance with the intervention protocol.
Intervention code [1] 331663 0
Treatment: Devices
Comparator / control treatment
The control group will receive a sham Goodair Nosebuds device for 2 weeks of home use. These sham devices are designed to maintain blinding by mimicking the look and superficial function of the active device, without producing the intended physiological effects. This approach enables placebo-controlled comparisons to assess the true impact of the Goodair Nosebuds on stress, anxiety, depression, and sleep.
Control group
Active

Outcomes
Primary outcome [1] 342378 0
Brain functional connectivity
Timepoint [1] 342378 0
Acute effects: Assessments will be made before, during, and immediately after each 12-minute session of device use. This will help capture any short-term or immediate changes in the participants Longitudinal effects: Evaluations will occur before the intervention begins and after 2 weeks of twice-daily use. This timing will help understand how the device impacts the participants' conditions over an extended period.
Primary outcome [2] 342379 0
HRV, EDA, and RR will be assessed as a composite primary outcome for the autonomic nervous system
Timepoint [2] 342379 0
Acute effects: Assessments will be made before, during, and immediately after each 12-minute session of device use. This will help capture any short-term or immediate changes in the participants Longitudinal effects: Evaluations will occur before the intervention begins and after 2 weeks of twice-daily use. This timing will help understand how the device impacts the participants' conditions over an extended period.
Secondary outcome [1] 450604 0
Sleep architecture and sleep quality This will be assessed as a composite outcome
Timepoint [1] 450604 0
Data from Fitbit wearables will be collected before the intervention to establish baseline measures of participants' physiological states. During the 2-week intervention, data will be recorded on a daily basis to monitor ongoing changes, ensuring consistent tracking of autonomic nervous system responses throughout the study. Data will also be collected on the post-intervention assessment session after the 4-week intervention period.
Secondary outcome [2] 450605 0
Self-reported sleep quality
Timepoint [2] 450605 0
PSQI questionnaire will be completed before and after the 2-week intervention.
Secondary outcome [3] 450606 0
Mental Health (Stress)
Timepoint [3] 450606 0
Before and after the 2-week intervention period.
Secondary outcome [4] 450980 0
Mental Health (Depression)
Timepoint [4] 450980 0
Before and after the 2-week intervention period.
Secondary outcome [5] 450981 0
Mental Health (Anxiety)
Timepoint [5] 450981 0
Before and after the 2-week intervention period.

Eligibility
Key inclusion criteria
Adults aged 18 years and older who self-report pre-clinical stress, anxiety, depression, or sleep issues and score 'mild' or 'moderate' on the DASS-21 or PSQI questionnaires are eligible for inclusion.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion criteria include individuals with a recent upper airway or sinus infection, a history of mental illness, respiratory conditions (except mild, well-controlled asthma), noticeable septum deviation or perforation, and allergies. Current smokers (including those who smoke cigarettes, vape, or use any form of smoking), as well as individuals who have quit smoking in the past five years or have used any form of tobacco or recreational drugs within the last three months, will also be excluded. Additionally, individuals with chronic conditions such as heart disease, cardiovascular disease, metabolic diseases (including diabetes), disorders of the autonomic nervous system, or any diagnosed neurological conditions are not eligible. Participants with noticeable septum deviation, perforation, or abnormal nasal mucosa will be excluded. Furthermore, individuals scoring 'normal,' 'severe,' or 'very severe' on the DASS-21 or PSQI questionnaires will not be eligible.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Following recruitment, screening and informed consent, eligible participants will be randomised using a randomisation schedule generated by a computer system.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomization will be achieved using a minimization/stratification randomization strategy. This approach ensures participants are assigned to one of two study arms (Breeze or control) in a balanced manner, accounting for factors like sex and self-reported symptom severity to represent the general population.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?

The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
1/04/2025
Date of last participant enrolment
Anticipated
Actual
1/05/2025
Date of last data collection
Anticipated
Actual
28/05/2025
Sample size
Target
16
Accrual to date
Final
12
Recruitment outside Australia
Country [1] 27264 0
New Zealand
State/province [1] 27264 0
Auckland

Funding & Sponsors
Funding source category [1] 318387 0
Other
Name [1] 318387 0
New Zealand College of Chiropractic
Country [1] 318387 0
New Zealand
Funding source category [2] 319623 0
Government body
Name [2] 319623 0
Foreign Technology Asssessment Support
Country [2] 319623 0
United States of America
Primary sponsor type
Other
Name
New Zealand College of Chiropractic
Address
Country
New Zealand
Secondary sponsor category [1] 320787 0
None
Name [1] 320787 0
Address [1] 320787 0
Country [1] 320787 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 318182 0
Central Health and Disability Ethics Committee
Ethics committee address [1] 318182 0
Ethics committee country [1] 318182 0
New Zealand
Date submitted for ethics approval [1] 318182 0
11/10/2024
Approval date [1] 318182 0
05/12/2024
Ethics approval number [1] 318182 0
Ethics reference: 2024 EXP 20600

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

Contacts
Principal investigator
Name 139758 0
Dr Imran Khan Niazi
Address 139758 0
New Zealand College of Chiropractic 6 Harrison Road Mount Wellington Auckland 1060
Country 139758 0
New Zealand
Phone 139758 0
+64 2102847764
Fax 139758 0
Email 139758 0
[email protected]
Contact person for public queries
Name 139759 0
Imran Khan Niazi
Address 139759 0
New Zealand College of Chiropractic 6 Harrison Road Mount Wellington Auckland 1060
Country 139759 0
New Zealand
Phone 139759 0
+64 2102847764
Fax 139759 0
Email 139759 0
[email protected]
Contact person for scientific queries
Name 139760 0
Imran Khan Niazi
Address 139760 0
New Zealand College of Chiropractic 6 Harrison Road Mount Wellington Auckland 1060
Country 139760 0
New Zealand
Phone 139760 0
+64 2102847764
Fax 139760 0
Email 139760 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
No


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.