ClinicalTrials.gg
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
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 269 studies in Hypoxia with a site in United States — 37 open to participants now, 52 under way, 2 of them phase 3. Hypoxia · United States.

Enrollment
116th of 181
20 · median 30
Started
2023
with 16 others
No phase
110 of 269
15 open now
Registered
211th of 269
by date

Among the 269 studies in Hypoxia with a site in United States, this one is the 116th largest by enrollment of the 181 interventional ones that give a count, is one of 17 that started in 2023, is one of 110 with no phase, and was the 211th registered.

Hypoxia

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

Browse Hypoxia studies →

Open to participants now

37 of the 269 studies in Hypoxia with a site in United States are open now. Recruiting first, the newest first:

32 more — sign in →

All 37 open studies →

A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →

Who these studies take

Of the 125 Hypoxia studies recruiting now, 53 (42%) set no upper age limit and 45 (36%) stop at 75 or younger; 15 take children under 18; 33 take healthy volunteers.

This study: 40 Years to 80 Years · all sexes · no healthy volunteers.

The full table on the hub →

This tab as a report to print or save as PDF → With an account.

Was this useful?
Watch this landscapeDownload CSVNarrow it in search →With an account: a weekly mail of what changed among 269 studies in Hypoxia with a site in United States, or all of them as a file.
02

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.

03

Conditions studied

  • Nocturnal Hypoxemia

Browse trials for

Keywords

  • hypoxemia, oxygen
04

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

  1. Subjects may be of any gender
  2. Subject's age must be 40 - 80 years
  3. 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:

  1. 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).
  2. Subjects with nasal obstruction
  3. Subjects taking any drugs that affect respiratory center drive
  4. Subject has an acute illness or hospitalization within the last 30 days
  5. Subject has a change in medication within the last 15 days
  6. Subject is currently receiving respiratory stimulant medications (such as acetazolamide, medroxyprogesterone, doxapram, theophylline/aminophylline, protriptyline and buspirone)
  7. Subject has significant comorbidities that in the opinion of the Investigator would interfere with outcomes and/or study conduct
  8. Subject's prescribed treatment is in conflict with study procedures
  9. Subjects with any unstable disease
05

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

06

What researchers measure

Primary outcomes

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

    oxygen saturation (SpO2)

    Time frame: 6 hours overnight

Secondary outcomes

  1. 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

  2. Time/% time above/below 90% target on initial setting and maximal setting

    oxygen saturation (SpO2)

    Time frame: 6 hours overnight

  3. 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

  4. Minimum/maximum SpO2 on initial setting and maximal setting

    oxygen saturation (SpO2)

    Time frame: 6 hours overnight

07

Study locations

1 site
  • Piedmont Healthcare
    Statesville, North Carolina 28625, United States
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

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 ↗
10

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.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

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.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion