NightOwl SpO2 Calibration Study
NOSCS
1 other identifier
interventional
12
1 country
1
Brief Summary
Calibration of a software module that computes Oxygen saturation(SpO2) based on photoplethysmography (PPG) traces acquired by the NightOwl reflectance-based PPG sensor which is placed on the finger. The study is designed in accordance with Medical electrical equipment - Part 2-61: Particular requirements for basic safety and essential performance of pulse oximeter equipment (ISO 80601- 2-61:2011)
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Dec 2019
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 7, 2019
CompletedStudy Start
First participant enrolled
December 7, 2019
CompletedFirst Posted
Study publicly available on registry
December 11, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2020
CompletedDecember 11, 2019
December 1, 2019
25 days
December 7, 2019
December 10, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
A_rms determination
After calibration of the NightOwl SpO2 software module, the A\_rms metric will be computed. This metric constitutes the performance metric proposed by ISO 80601-2-61:2011 Annex CC: Determination of accuracy. This metric captures the bias and precision of the computed SpO2 values compared to the benchmark.
Within 3 months after subject recruitment, the calibration and A_rms determination should have been performed
Study Arms (1)
Pulse oximeter calibration population
EXPERIMENTALAll subjects within this single arm of the study will undergo the calibration experiment as described in the Detailed Description
Interventions
The NightOwl is a finger and/or forehead mounted device with, among other functions, the capability to acquire double-wavelength PPG, from which SpO2 can be derived
Eligibility Criteria
You may qualify if:
- Healthy subjects with American Society of Anaesthesiologists health score (ASA) of 1 or 2, upon signing of informed consent.
- % of the study population or 2 subjects (whichever is larger) with dark pigmented skin should be included in the study
You may not qualify if:
- smokers or individuals exposed to high levels of carbon monoxide that result in elevated carboxyhemoglobin levels.
- individuals subject to conditions that result in elevated levels of methaemoglobin.
- individuals with arterial cannulation or hypoxia at FiO2 = 0,21
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Ectosense NVlead
Study Sites (1)
CMC
Genk, Limburg, 3600, Belgium
Study Officials
- PRINCIPAL INVESTIGATOR
Raf De Jongh, MD PhD
Ziekenhuis Oost-Limburg
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- BASIC SCIENCE
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 7, 2019
First Posted
December 11, 2019
Study Start
December 7, 2019
Primary Completion
January 1, 2020
Study Completion
January 1, 2020
Last Updated
December 11, 2019
Record last verified: 2019-12
Data Sharing
- IPD Sharing
- Will not share