Nocturnal HypoxemiaNCT06000332
Evaluation of POC Pulse-dose Demand Oxygen Delivery for Nocturnal Hypoxemia
A study testing InogenOne Rove 6 Portable Oxygen Concentrator in people with Nocturnal Hypoxemia, run by Inogen Inc. at 1 site in United States.
Trial 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 more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- Nocturnal Hypoxemia
- What is being tested?
- InogenOne Rove 6 Portable Oxygen Concentrator
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Oct 2023to 21 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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)
Show all 9Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Piedmont Healthcare
Statesville, North Carolina, 28625
About this 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.
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
- Nocturnal Hypoxemia
- Being tested
- InogenOne Rove 6 Portable Oxygen Concentrator
- Keywords
- hypoxemia, oxygen
- Medical subject headings
- Hypoxia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
InogenOne Rove 6 Portable Oxygen ConcentratorDevice
overnight use of Portable Oxygen Concentrator, 6 hours minimum
| Study group | Role | What they receive |
|---|---|---|
| InogenOne Rove 6 Portable Oxygen Concentrator | Experimental | InogenOne Rove 6 Portable Oxygen Concentrator Receives: Device: InogenOne Rove 6 Portable Oxygen Concentrator |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number/% of subjects that could achieve SpO2 ≥90% for >30% of sleep time
oxygen saturation (SpO2)
Measured: 6 hours overnight
Secondary outcomes (4)
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)
Measured: 6 hours overnight
Time/% time above/below 90% target on initial setting and maximal setting
oxygen saturation (SpO2)
Measured: 6 hours overnight
Number, duration, variability, and AUC of dips below 90% during sleep time on initial setting and maximal setting
oxygen saturation (SpO2)
Measured: 6 hours overnight
Minimum/maximum SpO2 on initial setting and maximal setting
oxygen saturation (SpO2)
Measured: 6 hours overnight
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2023
- Study start17 Oct 2023
- Primary completion21 Dec 2023
- Study completion21 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nocturnal HypoxemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Inogen Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Stanislav Glezer, MD, Study chair, Inogen Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06000332
- Sponsor's protocol ID
- INO-05
- Status last verified
- Jan 2024
- First submitted
- 13 Jul 2023
- Last updated
- 5 Jan 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of POC Pulse-dose Demand Oxygen Delivery for Nocturnal Hypoxemia
- ClinicalTrials.gov ID
- NCT06000332
- Acronym / sponsor ID
- INO-05
- Conditions
- Nocturnal Hypoxemia
- Keywords
- hypoxemia, oxygen
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Inogen Inc.Industry (pharma, biotech, devices)
- Study start
- 17 Oct 2023 (actual)
- Primary completion
- 21 Dec 2023 (actual)
- Study completion
- 21 Dec 2023 (actual)
- First posted
- 21 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| InogenOne Rove 6 Portable Oxygen Concentrator | Experimental | Device: InogenOne Rove 6 Portable Oxygen ConcentratorInogenOne Rove 6 Portable Oxygen Concentrator |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| InogenOne Rove 6 Portable Oxygen Concentratorovernight use of Portable Oxygen Concentrator, 6 hours minimum | Device | InogenOne Rove 6 Portable Oxygen Concentrator |
Primary outcome
Number/% of subjects that could achieve SpO2 ≥90% for >30% of sleep time
Time frame: 6 hours overnight
oxygen saturation (SpO2)
4 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
Time frame: 6 hours overnight
Time/% time above/below 90% target on initial setting and maximal setting
Time frame: 6 hours overnight
Number, duration, variability, and AUC of dips below 90% during sleep time on initial setting and maximal setting
Time frame: 6 hours overnight
Minimum/maximum SpO2 on initial setting and maximal setting
Time frame: 6 hours overnight
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jan 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stanislav Glezer, MD study chair
Inogen Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing InogenOne Rove 6 Portable Oxygen Concentrator in people with Nocturnal Hypoxemia, run by Inogen Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number/% of subjects that could achieve SpO2 ≥90% for >30% of sleep time (time frame: 6 hours overnight). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jan 2024.