Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622001109796p
Ethics application status
Submitted, not yet approved
Date submitted
18/07/2022
Date registered
11/08/2022
Date last updated
20/07/2023
Date data sharing statement initially provided
11/08/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
An intervention study to assess the accuracy of a novel non-invasive sensor to determine the Frequency Spectrum of the Lung in healthy volunteers
Scientific title

This is an intervention study to assess the accuracy and safety of a novel non-invasive sensors to determine the Frequency Spectrum of the Lung in healthy volunteers
Secondary ID [1] 307605 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:

Asthma 327070 0
COPD (Chronic Obstructive Pulmonary Diseases ) 327228 0
OSA (Obstructive Sleep Apnea ) 327229 0
Condition category
Condition code
Respiratory 324236 324236 0 0
Normal development and function of the respiratory system
Respiratory 324365 324365 0 0
Asthma
Respiratory 324366 324366 0 0
Chronic obstructive pulmonary disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The objective of this study is to analyze the efficiency and accuracy of NOXA1 sensors (using frequency range from 5Hz to 50Hz) to detect the lung spectrum on healthy volunteers.
In respiratory system the number of breaths in a minute is breathing rate. The average breathing rate is 12 breaths per minute. A digital recording with frequency analysis is a reliable technique for measuring lung sounds.
The frequency spectrum is required to detect changes in lung or lung vibration function dependence of airway closure and or the loss
of lung elasticity. In adults, an age dependence of lung sounds has been assumed, but exact investigations of this topic have not yet been done. This study will develop a digital method of analyzing vibration response of the lung. The normal frequency spectra of
inspiration (inhale) and expiration (exhale) are different and must be considered as individual characteristics.
The usual arrangement of lung sounds in frequency bands involves low, middle, and high frequency bands. In this study whether there are differences in sounds at different locations, recording the lung sounds in 12 various positions on the posterior chest and on
the back chest will be done. All calculations will be analyzed using NOXA1.
This research will lead to a more detailed frequency spectrum of the lung to determine and analyse the airflow in case of any lobe blockage or damage. Also, this study will be able to differentiate between mechanical and electrical models of the lung for monitoring
the respiratory system. Thus, the main objective of this research is to determine better ways of finding the frequency spectrum of the lung and designing an electrical model of the lung to monitor impedance/resistance changes in the respiratory system.
1.
-Main Procedure is as follows:
Then device set-up will be prepared, and sensors will be placed on the participants to collect the data.

Participants then will be requested to wear a CPAP as a part of data collection.

In this study the data will be collected under two different scenarios:

a) Firstly, the sensors will be placed on participants for 5-7minutes with participant’s normal breathing.

b) Secondly, the participants will be asked to wear a CPAP mask connected to a CPAP-PO (Continuous positive airways pressure oscillation) commercial device. They will breathe for 5-7 minutes while the sensors are recording the data. CPAP will provide 4cmH2O pressure, which is safe to be use with healthy volunteers. CPAP is being used for lung excitation.

NOX A1 and NOX C1 device is used to record 12 stations on chest and back. This study basically introducing an oscillating pressure to the lung and we will record the response. We will be recording this response for 10- 15minutes on each participant. NOX A1 can be used for the recording, downloading data, analysing, and reporting. Based on data collections after clinical trials frequency response of the lung can be determined. The device we are going to use externally on chest, so it is medically in low-risk category.

NOX A1 will produce oscillations/vibrations. We are going to use this device for lung excitation. This device is used to record 12 stations on chest and back, input will be given from mouth and response will be collected from chest.

NOX C1 is a Bluetooth access point that enables measurements, receiving and streaming of physiological signal. NOX C1 is intended to be used with NOX A1 system to enable online functionality of the system.

-Participants will attend single session only to record data.
- The complete session will be for an hour only max.
- The main researcher (Sarla Kumari) and supervising team who are having experience in this field.
- The location/setting where the assessments will take place: Waikato Institute of Technology (WINTEC), 51 Akoranga Rd Hamilton New Zealand. I am working for WINTEC so, we will conduct this study there.
NOXA1 and NOX C1 (medical devices with wireless access point that enables measurement ).
Intervention code [1] 324057 0
Diagnosis / Prognosis
Comparator / control treatment
This study is to develop non-invasive diagnose technique, there is no treatment involved in this study.
The results we will get from this study will be used in future trials with Asthma, COPD and OSA patients.
At this stage we are not comparing the results.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 332048 0
Efficiency and accuracy be considered together; will be analyzed together as a composite outcome.
The efficiency and accuracy of NOXA1 sensors to detect the lung spectrum on healthy volunteers - Both will be assessed by speed of collecting data-With the help of timer watch.
Timepoint [1] 332048 0
Will be assessed at a single session -15 minutes
Secondary outcome [1] 411982 0
Nil
Timepoint [1] 411982 0
Nil

Eligibility
Key inclusion criteria
All healthy participants will be recruited before their non-invasive study procedure.
Healthy volunteers age >= 18 years both genders
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
• Volunteers under any medication and having health conditions will be in exclusion criteria.
• Self-identified health conditions and the use of concomitant medication will be an exclusion criterion. The use of hormonal contraception is exclusionary.
• Participants with any history of, or current, respiratory disease are excluded from study participation.
• Volunteers with a history of childhood asthma / bronchiolitis will be exclusionary.

Study design
Purpose of the study
Diagnosis
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
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/10/2023
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
15
Accrual to date
Final
Recruitment outside Australia
Country [1] 24902 0
New Zealand
State/province [1] 24902 0
Hamilton

Funding & Sponsors
Funding source category [1] 311870 0
University
Name [1] 311870 0
Auckland University of Technology (AUT) IBTec
Country [1] 311870 0
New Zealand
Primary sponsor type
University
Name
Auckland University of Technology (AUT) IBTec
Address
Auckland University of Technology (AUT) IBTec, WT Building, 14/2 Wakefield Street Auckland-1142
Country
New Zealand
Secondary sponsor category [1] 313345 0
None
Name [1] 313345 0
Address [1] 313345 0
Country [1] 313345 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 311307 0
Southern Health and Disability Ethics Committee
Ethics committee address [1] 311307 0
133 Molesworth Street
Thorndon
Wellington 6011
Ethics committee country [1] 311307 0
New Zealand
Date submitted for ethics approval [1] 311307 0
19/04/2022
Approval date [1] 311307 0
Ethics approval number [1] 311307 0

Summary
Brief summary
This feasibility study will investigate the non-invasive diagnosis technique. This study will inform investigators of a final device design for subsequent pivotal trials to investigate the safety and efficacy of the non-invasive diagnosis technique.
The main objective of this research is to determine better ways of finding the frequency spectrum of the lung and designing an electrical model of the lung to monitor impedance/resistance changes in the respiratory system.

The study hypothesize that the tool can be differentiate between the frequency spectrum of the lung and help diagnose various lung diseases.

The objective of this study is to analyse the efficiency and accuracy of NOX1 sensors to detect the lung spectrum on healthy volunteers. This research includes healthy volunteers to prove efficiency, accuracy, and safety of NOX1 sensors to detect lung spectrum (breathing pattern).

This study is to check on the possibilities to develop a non- invasive tool which can correlate between the frequency spectrum of the lung and various lung diseases
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 120650 0
Mrs SARLA KUMARI
Address 120650 0
WINTEC (Waikato Institute of Technology) 51 Akoranga Road, Rotokauri, Hamilton 3200
Country 120650 0
New Zealand
Phone 120650 0
+64 2102315959
Fax 120650 0
Email 120650 0
skumari@aut.ac.nz
Contact person for public queries
Name 120651 0
Mrs SARLA KUMARI
Address 120651 0
WINTEC (Waikato Institute of Technology) 51 Akoranga Road, Rotokauri, Hamilton 3200
Country 120651 0
New Zealand
Phone 120651 0
+64 2102315959
Fax 120651 0
Email 120651 0
skumari@aut.ac.nz
Contact person for scientific queries
Name 120652 0
Mrs SARLA KUMARI
Address 120652 0
WINTEC (Waikato Institute of Technology) 51 Akoranga Road, Rotokauri, Hamilton 3200
Country 120652 0
New Zealand
Phone 120652 0
+64 2102315959
Fax 120652 0
Email 120652 0
skumari@aut.ac.nz

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
16666Informed consent form    384398-(Uploaded-18-07-2022-14-05-10)-Study-related document.pdf
16667Other    Questionnaire 384398-(Uploaded-18-07-2022-14-05-25)-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.