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An intervention study to assess the accuracy of a novel non-invasive sensor to determine the Frequency Spectrum of the Lung in healthy volunteers

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

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12622001109796
Enrollment
15
Registered
2022-08-11
Start date
2024-08-30
Completion date
Unknown
Last updated
2024-08-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

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

Interventions

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 dependenc

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 ).

Sponsors

Auckland University of Technology (AUT) IBTec
Lead SponsorUniversity

Study design

Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Diagnosis
Masking
Open (masking not used)

Eligibility

Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

All healthy participants will be recruited before their non-invasive study procedure. Healthy volunteers age >= 18 years both genders

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.

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026