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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

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

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 more

Trial 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.

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Who is eligible to take part in this trial?

"To be considered as a participant in this experiment, applicants must have nighttime oxygen deprivation and fall within the 40 to 80 age bracket. This clinical trial aims to enrol 20 patients."

Answered by AI

Do individuals of a certain age qualification have access to this medical trial?

"Only individuals aged between 40 and 80 qualify for this medical trial. Those below 18 or over 65 are not eligible, with 33 studies dedicated to the former group and 87 specifically targeting seniors."

Answered by AI

How many participants are welcomed into this research program?

"Affirmative. Details on clinicaltrials.gov show that this medical study, first uploaded 17th October 2021, is actively recruiting patients. 20 participants are needed at one clinic site for the trial to continue."

Answered by AI

Are participants being added to this trial currently?

"Affirmative, clinicaltrials.gov affirms that this investigation is currently enlisting participants. It was originally posted on October 17th 2023 and last revised two days later."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Evaluation of POC Pulse-dose Demand Oxygen Delivery for Nocturnal Hypoxemia

2023. "Evaluation of POC Pulse-dose Demand Oxygen Delivery for Nocturnal Hypoxemia". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06000332.