CompletedNCT06000332Updated Jan 5, 2024

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

An interventional study of InogenOne Rove 6 Portable Oxygen Concentrator in Nocturnal Hypoxemia, sponsored by Inogen Inc.. Completed at 1 site in United States. Open to participants aged 40 Years to 80 Years. Per ClinicalTrials.gov, last updated 2024-01-05.

Sponsored by Inogen Inc. · Not applicable, Interventional, and Treatment

From the registry’s dates

Primary completion was Dec 2023, 2 years 10 months ago, and no results have been posted to the registry.

Phase: Not applicable
Study type: Interventional
Enrollment: 20
Allocation: Not applicable
Ages: 40 Years to 80 Years
Sex: All

Study summary

The aim of this study is to describe the effect of the Inogen Rove 6 Portable Oxygen Concentrator on peripheral oxygen saturation in adults receiving supplemental oxygen at night and examine whether the device can adequately maintain oxygen saturation during sleep.

Read the detailed description

The study design is a prospective, single site, single arm, open label, pilot study. The aim of this study is to describe the effect of the Inogen Rove 6 Portable Oxygen Concentrator on peripheral oxygen saturation in adults receiving supplemental oxygen at night and examine whether the device can adequately maintain oxygen saturation during sleep, i.e., achieve target with initial titration setting and/or with any needed adjustments of setting.

Conditions studied

Nocturnal Hypoxemia

Browse trials for

Hypoxia 1,076

Keywords

hypoxemia, oxygen

In context

Hypoxia

1,076 studies on the registry are indexed under Hypoxia; 213 are open to participants now.

This study's enrollment of 20 is below the median of 45 across 769 interventional studies indexed under Hypoxia.

Browse Hypoxia studies →

Lead sponsor

Inogen Inc. is the lead sponsor of 5 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 40 Years to 80 Years
Sexes eligible: All
Accepts healthy volunteers: No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

Subjects may be of any gender
Subject's age must be 40 - 80 years
Subjects must have a current prescription for nocturnal oxygen \< 3 L/min continuous or current use of a Portable Oxygen Concentrator.

Exclusion criteria

Exclusion Criteria:

Subject is using any ancillary medical device(s) that may interfere with the operation of or data interpretation from the InogenOne device (such as CPAP/BiPAP, NIV).
Subjects with nasal obstruction
Subjects taking any drugs that affect respiratory center drive
Subject has an acute illness or hospitalization within the last 30 days
Subject has a change in medication within the last 15 days
Subject is currently receiving respiratory stimulant medications (such as acetazolamide, medroxyprogesterone, doxapram, theophylline/aminophylline, protriptyline and buspirone)
Subject has significant comorbidities that in the opinion of the Investigator would interfere with outcomes and/or study conduct
Subject's prescribed treatment is in conflict with study procedures
Subjects with any unstable disease

Study design

Phase: Not applicable
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrollment: 20 participants (actual)

Study arms

Experimental
InogenOne Rove 6 Portable Oxygen Concentrator
InogenOne Rove 6 Portable Oxygen Concentrator
Device: InogenOne Rove 6 Portable Oxygen Concentrator

Interventions

DeviceInogenOne Rove 6 Portable Oxygen Concentrator
overnight use of Portable Oxygen Concentrator, 6 hours minimum

What researchers measure

Primary outcomes

Number/% of subjects that could achieve SpO2 ≥90% for >30% of sleep time
oxygen saturation (SpO2)
Time frame: 6 hours overnight

Secondary outcomes

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
oxygen saturation (SpO2)
Time frame: 6 hours overnight
Time/% time above/below 90% target on initial setting and maximal setting
oxygen saturation (SpO2)
Time frame: 6 hours overnight
Number, duration, variability, and AUC of dips below 90% during sleep time on initial setting and maximal setting
oxygen saturation (SpO2)
Time frame: 6 hours overnight
Minimum/maximum SpO2 on initial setting and maximal setting
oxygen saturation (SpO2)
Time frame: 6 hours overnight

Study locations

1 site

Piedmont Healthcare
Statesville, North Carolina 28625, United States

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

Timeline

Tracking since Sep 25, 2026

ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Oct 2023 to primary completion in Dec 2023, 2 months.

Of 30 industry-sponsored interventional studies with no phase under Hypoxia, half reached primary completion within 1 month of starting (the median), counting those still running; a quarter within 0 and three quarters within 6. This study's 2 months is above that.

Counting every sponsor, half of 351 studies reached it within 12 months; a quarter within 3 and three quarters within 27.

How these figures are worked out, and which studies are left out of them.

Registered: Jul 13, 2023
First posted: Aug 21, 2023
StartActual: Oct 17, 2023
Primary completionActual: Dec 21, 2023
CompletionActual: Dec 21, 2023
Last update: Jan 5, 2024

What these dates mean

Start.: When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.: When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.: When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.: Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.

No changes since tracking began. The registry record was last updated on Jan 5, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT06000332
Lead sponsor: Inogen Inc.
Responsible party: Sponsor
First posted: Aug 21, 2023
Start date: Oct 17, 2023
Primary completion: Dec 21, 2023
Completion: Dec 21, 2023
Last update: Jan 5, 2024

Study contacts

Stanislav Glezer, MD

study chair · Inogen Inc.

Oversight

FDA-regulated drug: No
FDA-regulated device: Yes

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2024. You cannot join it, but the record below documents what was studied.

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Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

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Other studies in this condition

Hypoxia →

Other studies from this sponsor

Inogen Inc.

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