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Adult healthy subjects for Hypoxia

N/A
Waitlist Available
Research Sponsored by Nihon Kohden
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 30 minutes
Awards & highlights
No Placebo-Only Group

Summary

The aim of this study is to determine the accuracy of devices called pulse oximeters, which measure blood oxygen by shining light through fingers, ears or other skin, without requiring blood sampling. Study will be used with patients at rest

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~30 minutes
This trial's timeline: 3 weeks for screening, Varies for treatment, and 30 minutes for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Root-mean-square (Rms) of device Pulse Rate measurement with room air stabilization is within +-3 [1/min] of reference ECG Pulse Rate measurement at heart rates (30 to 300 [1/min])
Root-mean-square (Rms) of device SpO2 measurement with room air stabilization is within +-2% [%SpO2] of reference co-oximeter SaO2 measurement at varying desaturation levels (70% to 100%)
Secondary study objectives
Root-mean-square (Rms) of device SpO2 measurement with room air stabilization is within +-2% [%SpO2] of reference co-oximeter SaO2 measurement at desaturation levels (80% to 100%) and within +-3% [%SpO2] at desaturation levels (70% to 80%)

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: Adult healthy subjectsExperimental Treatment1 Intervention
Adult healthy subjects capable of undergoing controlled hypoxemia to the levels outlined in the desaturation profile in an at rest state
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Pulse oximeter
2020
N/A
~720

Find a Location

Who is running the clinical trial?

Nihon KohdenLead Sponsor
17 Previous Clinical Trials
923 Total Patients Enrolled
6 Trials studying Hypoxia
68 Patients Enrolled for Hypoxia
University of California, San FranciscoOTHER
2,572 Previous Clinical Trials
15,175,977 Total Patients Enrolled
22 Trials studying Hypoxia
11,166 Patients Enrolled for Hypoxia
~3 spots leftby Oct 2025
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