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NCT05995613 · ClinicalTrials.gov registry record
Evaluation of MABOS for Improved Pulse Oximeter Accuracy in Patients of Color
A clinical trial of Oxygen Saturation, sponsored by University of North Carolina, Chapel Hill.
- Completed
- Registry status
- 9
- Enrollment target
- 1
- Study location
NCT05995613 is a study of Oxygen Saturation that has completed, run by University of North Carolina, Chapel Hill. The registered enrollment target is 9 participants. The trial reports 1 study location across 1 state.
The verdict
NCT05995613, a study of Oxygen Saturation, has completed, sponsored by University of North Carolina, Chapel Hill.
- COMPLETED
- Registry status
- 9 participants
- Enrollment target
- 1
- Study location
Study Summary
Purpose: Investigate the safe wearability and basic functionality - epidermal melanin concentration and blood oxygen estimation - of our developed device: Melanin-Adjusted Blood Oxygen Sensor (MABOS) Participants: Healthy adults 18-65 years of age Procedures (methods): The investigators plan to enroll 12 healthy adult participants for the study. The investigators aim to enroll 4 participants with skin tones associated with those of African descent (Group A), 4 of East Asian descent (Group B), and 4 of European descent (Group C). Additionally, the investigators aim to ensure half of group is male, and the other half female. For the duration of the study, two wearable devices will be placed on the participant: a Nonin PureSat pulse oximeter on a forefinger, and the novel wearable pulse oximeter - MABOS - on the other forefinger. Prior to testing, an Ocean HR2 XR Spectrometer will be used to assess the absorbance of three wavelengths of light - 410, 660, 940 nm - on each patient's inner wrist. Following this, the two devices will be placed on the patient, set up, and calibrated for 10 minutes. During the calibration period, MABOS will be used to measure the same three wavelengths of light utilized by the Ocean HR2 XR Spectrometer (410, 660, and 940 nm). After the calibration period, all participants will be asked to perform the following procedure 5 times as part of the testing period: a deep inhalation lasting no longer than 10 seconds, followed by a slow exhalation lasting no longer than 30 seconds. Between each trial, a five-minute break will be required. For the entire testing period, all two devices will be continuously acquiring data. After this testing period, all two devices will continue taking measurements until 90 minutes have elapsed. Skin integrity will be examined before spectrometer use, after spectrometer use, after the calibration period, every 30 minutes after the start of the testing period, and after the testing period. During the study, if the pa
Conditions Studied
Interventions
- DEVICE MABOS
- DEVICE Nonin PureSat
Study Locations (1)
North Carolina
- University of North Carolina at Chapel Hill - Chapel Hill
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 9 participants |
| Start Date | 2023-09-06 |
| Est. Completion | 2024-02-01 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05995613
The ClinicalTrials.gov registry entry for NCT05995613 describes a study currently listed as completed, categorized as an unspecified phase. The registered enrollment target is 9 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of North Carolina, Chapel Hill, which has 1,109 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Oxygen Saturation appearing as the primary indexed condition, and to 2 interventions - of which MABOS is the first listed.
NCT05995613 reports 1 study location spanning 1 distinct geographic area - top geographies include North Carolina.
Frequently Asked Questions
What is clinical trial NCT05995613 about?
NCT05995613 is a clinical study titled "Evaluation of MABOS for Improved Pulse Oximeter Accuracy in Patients of Color". Purpose: Investigate the safe wearability and basic functionality - epidermal melanin concentration and blood oxygen estimation - of our developed device: Melanin-Adjusted Blood Oxygen Sensor (MABOS) Participants: Healthy adults 18-65 years of age Procedures (methods): The investigators plan to en...
What is the current status of trial NCT05995613?
This trial is currently completed. The enrollment target is 9 participants. The study started on 2023-09-06. Estimated completion is 2024-02-01.
What conditions does trial NCT05995613 study?
This clinical trial studies the following conditions: Oxygen Saturation.
What interventions are being tested in trial NCT05995613?
The interventions under investigation include: MABOS (DEVICE), Nonin PureSat (DEVICE).
Who is sponsoring clinical trial NCT05995613?
This trial is sponsored by University of North Carolina, Chapel Hill, which has 1,109 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05995613 being conducted?
This trial has 1 study location across North Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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