Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12624001376538p
Ethics application status
Submitted, not yet approved
Date submitted
17/10/2024
Date registered
20/11/2024
Date last updated
20/11/2024
Date data sharing statement initially provided
20/11/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
Effects of using an augmented breathing device on stress, anxiety, depression, and sleep
Scientific title
Effects of using an augmented breathing device in people with self-reported mild or moderate stress, anxiety, depression, and sleep problems
Secondary ID [1] 313057 0
None
Universal Trial Number (UTN)
U1111-1313-7678
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Mild to moderate sleep problems 335288 0
Mild to moderate stress and anxiety 335490 0
Mild to moderate depression 335491 0
Condition category
Condition code
Respiratory 331862 331862 0 0
Other respiratory disorders / diseases
Mental Health 331863 331863 0 0
Anxiety
Mental Health 331864 331864 0 0
Depression
Neurological 331865 331865 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 to deliver mechanostimulation to the nasal airway mucosa during breathing.
Modes of Operation: The device has two modes:
1) Breeze Mode: Provides humming stimulation to both sides of the nose without airflow regulation.
2) Relax Mode: Applies lateralized humming and airflow regulation that alternates between each side of the nose every 3 minutes.
Usage: Participants will use the Nosebuds for 12 minutes, twice daily, over a 4-week period. The timing for device use is 12 minutes because the cycling mode of the device requires 3 minutes per cycle. Therefore, to complete two cycles, each lasting 3 minutes, the total duration sums up to 12 minutes.
a) The study will have two separate groups of participants, with each group assigned to a different mode of the Nosebuds. One group will use the Breeze (Decongestion) mode, while the other group will exclusively use the Relax (De-stress) mode throughout the study. This approach allows for a direct comparison of the effects of each mode on the participants.
b) Usage Timing: Participants are instructed to use the Nosebuds twice daily for 12 minutes each session. The specific timing within the day isn’t rigid; participants can choose when to use the device.
c) Position During Use: The Nosebuds can be used while sitting or lying down, but there is no requirement to be in a specific position during usage. Participants are encouraged to be comfortable while using the device
d) Adherence Monitoring: Adherence to the intervention will be assessed primarily through self-reporting, where participants may maintain a diary to log their daily usage.
Intervention code [1] 329613 0
Treatment: Devices
Comparator / control treatment
The study includes a control group that will not receive the Goodair Nosebuds device for 4-week home use. This control group allows for comparison between those using the device and those receiving no intervention, in order to assess the longitudinal effects of the Goodair Nosebuds on modulating stress, anxiety, depression, and sleep.
Control group
Active

Outcomes
Primary outcome [1] 339477 0
Brain functional connectivity
Timepoint [1] 339477 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 4 weeks of twice-daily use. This timing will help understand how the device impacts the participants' conditions over an extended period.
Primary outcome [2] 339614 0
HRV, EDA, and RR will be assessed as a composite primary outcome for the autonomic nervous system
Timepoint [2] 339614 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 4 weeks of twice-daily use. This timing will help understand how the device impacts the participants' conditions over an extended period.
Secondary outcome [1] 440149 0
Sleep architecture and sleep quality This will be assessed as a composite outcome
Timepoint [1] 440149 0
Data from Fitbit wearables will be collected before the intervention to establish baseline measures of participants' physiological states. During the 4-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] 440597 0
Self-reported sleep quality
Timepoint [2] 440597 0
PSQI questionnaire will be completed before and after the 4-week intervention.
Secondary outcome [3] 440766 0
Mental Health (Stress, Anxiety, Depression)
Timepoint [3] 440766 0
Before and after the 4-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. This will be held by a third party.
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 three study arms (Breeze, Relax, 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
Not yet recruiting
Date of first participant enrolment
Anticipated
25/11/2024
Actual
Date of last participant enrolment
Anticipated
1/09/2025
Actual
Date of last data collection
Anticipated
1/12/2025
Actual
Sample size
Target
60
Accrual to date
Final
Recruitment outside Australia
Country [1] 26576 0
New Zealand
State/province [1] 26576 0
Auckland

Funding & Sponsors
Funding source category [1] 317499 0
Other
Name [1] 317499 0
New Zealand College of Chiropractic
Country [1] 317499 0
New Zealand
Funding source category [2] 317643 0
Government body
Name [2] 317643 0
Foreign Technology Assessment Support
Country [2] 317643 0
United States of America
Primary sponsor type
Other
Name
New Zealand College of Chiropractic
Address
Country
New Zealand
Secondary sponsor category [1] 319794 0
None
Name [1] 319794 0
Address [1] 319794 0
Country [1] 319794 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 316210 0
Health and Disability Ethics Committee
Ethics committee address [1] 316210 0
Ethics committee country [1] 316210 0
New Zealand
Date submitted for ethics approval [1] 316210 0
11/10/2024
Approval date [1] 316210 0
Ethics approval number [1] 316210 0

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

Contacts
Principal investigator
Name 137158 0
Dr Imran Khan Niazi
Address 137158 0
New Zealand College of Chiropractic 6 Harrison Road Mount Wellington Auckland 1060
Country 137158 0
New Zealand
Phone 137158 0
+64 2102847764
Fax 137158 0
Email 137158 0
[email protected]
Contact person for public queries
Name 137159 0
Imran Khan Niazi
Address 137159 0
New Zealand College of Chiropractic 6 Harrison Road Mount Wellington Auckland 1060
Country 137159 0
New Zealand
Phone 137159 0
+64 2102847764
Fax 137159 0
Email 137159 0
[email protected]
Contact person for scientific queries
Name 137160 0
Imran Khan Niazi
Address 137160 0
New Zealand College of Chiropractic 6 Harrison Road Mount Wellington Auckland 1060
Country 137160 0
New Zealand
Phone 137160 0
+64 2102847764
Fax 137160 0
Email 137160 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.