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Device
Portable Oxygen Concentrator for Nocturnal Hypoxemia
N/A
Waitlist Available
Research Sponsored by Inogen Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 hours overnight
Awards & highlights
Study Summary
This trial studied how well a portable oxygen device could maintain oxygen levels during sleep for adults with breathing problems.
Eligible Conditions
- Nocturnal Hypoxemia
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 6 hours overnight
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 hours overnight
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Number/% of subjects that could achieve SpO2 ≥90% for >30% of sleep time
Secondary outcome measures
Minimum/maximum SpO2 on initial setting and maximal setting
Number, duration, variability, and AUC of dips below 90% during sleep time on initial setting and maximal setting
Number/% of subjects requiring increased settings and the difference between initial and maximal settings required to meet target SpO2 ≥90% for >30% of sleep time criteria
+1 moreTrial Design
1Treatment groups
Experimental Treatment
Group I: InogenOne Rove 6 Portable Oxygen ConcentratorExperimental Treatment1 Intervention
InogenOne Rove 6 Portable Oxygen Concentrator
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
InogenOne Rove 6 Portable Oxygen Concentrator
2023
N/A
~20
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Who is running the clinical trial?
Inogen Inc.Lead Sponsor
3 Previous Clinical Trials
149 Total Patients Enrolled
Stanislav Glezer, MDStudy ChairInogen Inc.
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