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

No Placebo-Only Group

Summary

This trial is testing a portable oxygen machine to see if it can keep adults' oxygen levels stable while they sleep. The study focuses on people who need extra oxygen at night and checks if the device works well enough to maintain their oxygen levels.

Eligible Conditions

Sleep Apnea

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 6 hours overnight

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~6 hours overnight

This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 hours overnight for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Number/% of subjects that could achieve SpO2 ≥90% for >30% of sleep time

Secondary study objectives

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

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