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Assessment of Oxygenation and Respiratory Health in the Community

Community-Based Evaluation of Respiratory Health and Oxygenation Devices in Maori and Pasifika Populations

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12626000611325
Acronym
ORA (Oxygenation Respiratory Assessment)
Enrollment
100
Registered
2026-05-18
Start date
2026-10-26
Completion date
2027-06-30
Last updated
2026-05-25

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 study aims to evaluate the performance and reliability of non-invasive respiratory and oxygenation monitoring devices, along with their usability and acceptability in Maori and Pasifika community settings. It also explores how participants self-fit common respiratory masks, focusing on comfort, ease of use, and potential fitting issues that may affect data quality. Healthy adult participants will be recruited from community events and will complete a short demographic questionnaire. During a single ~15-minute session, participants will use non-invasive devices to collect respiratory and oxygenation data, with comparisons made to standard tools such as spirometry and finger pulse oximetry, although the main focus is on user experience rather than clinical accuracy. A total of 50–100 participants will be recruited over 12–24 months.

Interventions

Interventional Description of the intervention or exposure: Community based testing of a Neck Pulse Sensor and At-Home Spirometer All participants undergo the same protocol (single-cohort design) WHY: Test non-invasive devices for detecting resting and day-to-day changes in venous oxygen saturation (SvO2) and airway function for people in the community for better at home monitoring of conditions MATERIALS: • Custom-developed reflectance pulse oximetry sensor with red and infrared LEDs, photode

Interventional Description of the intervention or exposure: Community based testing of a Neck Pulse Sensor and At-Home Spirometer All participants undergo the same protocol (single-cohort design) WHY: Test non-invasive devices for detecting resting and day-to-day changes in venous oxygen saturation (SvO2) and airway function for people in the community for better at home monitoring of conditions MATERIALS: • Custom-developed reflectance pulse oximetry sensor with red and infrared LEDs, photodetectors, and integrated temperature protection (potential at-home sensor). This sensor measured venous oxygen saturation (SvO2) from the jugular veins and arterial oxygen saturation (SaO2) from the carotid artery, rather than just SaO2 like current existing sensors. • Custom-developed at home spirometer for lung function testing (potential at-home sensor) • EasyOne spirometer for reference • Medical-grade adhesive (Tegaderm) for sensor placement • Commercial finger pulse oximeter for SaO2 reference PROCEDURES: • Participant demographics and baseline measurements recorded (age, sex, height, weight, skin type, predicted max heart rate) • Neck sensor applied using neck ultrasound for guiding placement over the jugular veins with the sensor held in place with medical grade adhesive (Tegaderm) before recording initiated. Commercial pulse oximeter will also be placed on a finger at this point • Baseline spirometry measured using at-home developed device and EasyOne spirometer (~1 minute each test) • Once both spirometry tests are completed, the patient will fit a facemask on themselves while the research observes how well they do it • Neck sensor is removed and cleaned along with facemask according to protocol WHO PROVIDED: Research staff will perform the testing and monitor sensor performance. Staff have GCP certificates and are trained in using the sensors HOW: • Single, face-to-face supervised session • Individual use • Testing will be completed within a 15 minute period • Neck sensor will be on and recording for the entire test • Spirometry measurements will be recorded once on each device (1 minute recording on at home device and 3 acceptable results on the EasyOne Spirometer) LOCATION: Various community events around New Zealand (mobile testing unit) TAILORING: • Sensor placement adjusted for neck anatomy using an ultrasound for optimal placement • Mask fitted to participant face (XS, S, M, L and XL mask available) NUMBER AND DURATION OF SENSOR ASSESSMENTS: • Single visit per participant, ~15 minutes in total • Neck sensor records continuously during the spirometry testing and mask fit Spirometer measurements take ~1 minute each test ADHERENCE MONITORING STRATEGIES: • Research staff check sensor positioning and signal quality during the testing • Any sensor issues or signal loss documented • Spirometer testing will be repeated if unsatisfactory

Sponsors

University of Canterbury
Lead SponsorUniversity

Study design

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

Eligibility

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

Inclusion criteria

Identifies as Maori or Pasifika Able to provide informed consent Healthy adult

Exclusion criteria

Acute illness or infection at the time of testing that could pose a safety risk.

Outcome results

None listed

Source: ANZCTR · Data processed: Sep 19, 2026