CognitionNCT06555484
Acute Effects of Supplemental Oxygen on Memory Testing in Healthy Adult Volunteers
A study testing Cross Over Assignment Supplemental Oxygen and Supplemental Air in people with Cognition, run by Inogen Inc. at 1 site in United States.
Trial summary
Forty healthy adults (i.e., not recruited with respect to any particular diagnosis) are each alternately provided with supplemental oxygen and air via nasal cannula at about 6 Liters per Minute (LPM), while completing memory tests. Read more about this study
- Who is it for?
- Ages 22 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Cognition
- What is being tested?
- Cross Over Assignment Supplemental Oxygen and Supplemental Air
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 28 May 2024to 31 Oct 2024
- 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 22 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Subjects are intended to represent "healthy adults." Patients will include a mix of self-reported gender and ethnic/racial identification.
- Provision of signed and dated informed consent form
- Stated willingness to comply with all study procedures and availability for the duration of the study
- Adult (aged 22+)
Who cannot join
- Patients who self-report diagnosis of respiratory-related conditions will be excluded.
- Subjects with a known polyvinyl chloride (PVC) allergy will be excluded, due to potential use of a standard, PVC-based cannula in the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Acute Effects of Supplemental Oxygen on Memory in Healthy Older Adults: a Double-Blind Within-Subject Crossover Study
Forty healthy adults (i.e., not recruited with respect to any particular diagnosis) are each alternately provided with supplemental oxygen and air via nasal cannula at about 6 Liters per Minute (LPM), while completing memory tests.
Read the detailed description
Prior studies have reported that supplemental oxygen can confer acute benefits to cognition. Here, the investigators seek to replicate/extend such findings by assessing whether such benefits can be seen using an Inogen oxygen concentrator with subjects with an average age around 65 years old. The investigators include a standard measure of cognition previously reported to be sensitive to supplemental oxygen (2-back test) and a novel, in-development adaptation of a memory test for medical-related content (Medical icons spatial test).
- Conditions
- Cognition
- Being tested
- Cross Over Assignment Supplemental Oxygen and Supplemental Air
- Keywords
- Oxygen Concentrator, Hyperoxia
- Medical subject headings
- Hyperoxia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cross Over Assignment Supplemental Oxygen and Supplemental AirDevice
Subjects repeatedly complete memory tests, either first while breathing supplemental oxygen or first while breathing "supplemental air" (in an order randomly assigned).
| Study group | Role | What they receive |
|---|---|---|
| Air First | Other | All study participants, completing memory tests while breathing either supplemental oxygen followed by air, or breathing air followed oxygen. Receives: Device: Cross Over Assignment Supplemental Oxygen and Supplemental Air |
| Oxygen First | Other | All study participants, completing memory tests while breathing either supplemental oxygen followed by air, or breathing air followed oxygen. Receives: Device: Cross Over Assignment Supplemental Oxygen and Supplemental Air |
What is being measured
The primary outcome is the main question the study is designed to answer.
2 back Memory test performance
# correct on 2-back test
Measured: At baseline and 5 mins post-intervention exposure
Memory test performance
New Medical Icons Spatial Test
Measured: At baseline and 5 mins post-intervention exposure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2024
- Study start28 May 2024
- Primary completion31 Oct 2024
- Study completion31 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for CognitionStudies 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Acute effects of oxygen on memory testing in healthy adult volunteers
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Inogen Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Marc Egeth, Principal investigator, Inogen Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06555484
- Sponsor's protocol ID
- INO-06
- Status last verified
- Jan 2025
- First submitted
- 27 Jul 2024
- Last updated
- 31 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Choi MH, Kim HJ, Kim JH, Kim HS, Choi JS, Yi JH, Tack GR, Chung YS, Son I, Chung SC. Correlation between cognitive ability measured by response time of 1-back task and changes of SpO2 by supplying three different levels of oxygen in the elderly. Geriatr Gerontol Int. 2013 Apr;13(2):384-7. doi: 10.1111/j.1447-0594.2012.00911.x. Epub 2012 Jul 23.
PubMed 22817401Chung SC, Kwon JH, Lee HW, Tack GR, Lee B, Yi JH, Lee SY. Effects of high concentration oxygen administration on n-back task performance and physiological signals. Physiol Meas. 2007 Apr;28(4):389-96. doi: 10.1088/0967-3334/28/4/005. Epub 2007 Mar 7.
PubMed 17395994McMorris T, Hale BJ, Barwood M, Costello J, Corbett J. Effect of acute hypoxia on cognition: A systematic review and meta-regression analysis. Neurosci Biobehav Rev. 2017 Mar;74(Pt A):225-232. doi: 10.1016/j.neubiorev.2017.01.019. Epub 2017 Jan 19.
PubMed 28111267Sohn JH, Chung SC, Jang EH. 30% oxygen inhalation enhances cognitive performance through robust activation in the brain. J Physiol Anthropol Appl Human Sci. 2005 Jan;24(1):51-3. doi: 10.2114/jpa.24.51.
PubMed 15684544Shaw DM, Bloomfield PM, Gant N. The effect of acute normobaric hyperoxia on cognition: A systematic review, meta-analysis and meta-regression. Physiol Behav. 2023 Aug 1;267:114208. doi: 10.1016/j.physbeh.2023.114208. Epub 2023 Apr 29.
PubMed 37121344
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acute Effects of Supplemental Oxygen on Memory in Healthy Older Adults: a Double-Blind Within-Subject Crossover Study
- ClinicalTrials.gov ID
- NCT06555484
- Acronym / sponsor ID
- INO-06
- Conditions
- Cognition
- Keywords
- Oxygen Concentrator, Hyperoxia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Inogen Inc.Industry (pharma, biotech, devices)
- Study start
- 28 May 2024 (actual)
- Primary completion
- 31 Oct 2024 (actual)
- Study completion
- 31 Oct 2024 (actual)
- First posted
- 15 Aug 2024 (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.
Forty healthy adults (i.e., not recruited with respect to any particular diagnosis) are each alternately provided with supplemental oxygen and air via nasal cannula at about 6 Liters per Minute (LPM), while completing memory tests.
Detailed description
Prior studies have reported that supplemental oxygen can confer acute benefits to cognition. Here, the investigators seek to replicate/extend such findings by assessing whether such benefits can be seen using an Inogen oxygen concentrator with subjects with an average age around 65 years old. The investigators include a standard measure of cognition previously reported to be sensitive to supplemental oxygen (2-back test) and a novel, in-development adaptation of a memory test for medical-related content (Medical icons spatial test).
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Acute effects of oxygen on memory testing in healthy adult volunteers
| Arm | Type | Receives |
|---|---|---|
| Air First | Other | Device: Cross Over Assignment Supplemental Oxygen and Supplemental AirAll study participants, completing memory tests while breathing either supplemental oxygen followed by air, or breathing air followed oxygen. |
| Oxygen First | Other | Device: Cross Over Assignment Supplemental Oxygen and Supplemental AirAll study participants, completing memory tests while breathing either supplemental oxygen followed by air, or breathing air followed oxygen. |
Who may qualify
- Ages
- 22 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Subjects are intended to represent "healthy adults." Patients will include a mix of self-reported gender and ethnic/racial identification.
- Provision of signed and dated informed consent form
- Stated willingness to comply with all study procedures and availability for the duration of the study
- Adult (aged 22+)
Key exclusion criteria (2 listed)
- Patients who self-report diagnosis of respiratory-related conditions will be excluded.
- Subjects with a known polyvinyl chloride (PVC) allergy will be excluded, due to potential use of a standard, PVC-based cannula in the study.
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 |
|---|---|---|
| Cross Over Assignment Supplemental Oxygen and Supplemental AirSubjects repeatedly complete memory tests, either first while breathing supplemental oxygen or first while breathing "supplemental air" (in an order randomly assigned). | Device | Air First, Oxygen First |
Primary outcome
2 back Memory test performance
Time frame: At baseline and 5 mins post-intervention exposure
# correct on 2-back test
Memory test performance
Time frame: At baseline and 5 mins post-intervention exposure
New Medical Icons Spatial Test
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 31 Jan 2025.
- Background: PubMed 22817401Choi MH, Kim HJ, Kim JH, Kim HS, Choi JS, Yi JH, Tack GR, Chung YS, Son I, Chung SC. Correlation between cognitive ability measured by response time of 1-back task and changes of SpO2 by supplying three different levels of oxygen in the elderly. Geriatr Gerontol Int. 2013 Apr;13(2):384-7. doi: 10.1111/j.1447-0594.2012.00911.x. Epub 2012 Jul 23.
- Background: PubMed 17395994Chung SC, Kwon JH, Lee HW, Tack GR, Lee B, Yi JH, Lee SY. Effects of high concentration oxygen administration on n-back task performance and physiological signals. Physiol Meas. 2007 Apr;28(4):389-96. doi: 10.1088/0967-3334/28/4/005. Epub 2007 Mar 7.
- Background: PubMed 28111267McMorris T, Hale BJ, Barwood M, Costello J, Corbett J. Effect of acute hypoxia on cognition: A systematic review and meta-regression analysis. Neurosci Biobehav Rev. 2017 Mar;74(Pt A):225-232. doi: 10.1016/j.neubiorev.2017.01.019. Epub 2017 Jan 19.
- Background: PubMed 15684544Sohn JH, Chung SC, Jang EH. 30% oxygen inhalation enhances cognitive performance through robust activation in the brain. J Physiol Anthropol Appl Human Sci. 2005 Jan;24(1):51-3. doi: 10.2114/jpa.24.51.
- Background: PubMed 37121344Shaw DM, Bloomfield PM, Gant N. The effect of acute normobaric hyperoxia on cognition: A systematic review, meta-analysis and meta-regression. Physiol Behav. 2023 Aug 1;267:114208. doi: 10.1016/j.physbeh.2023.114208. Epub 2023 Apr 29.
- Related InfoLink provided by the sponsor.
- Related InfoLink provided by the sponsor.
- Related InfoLink provided by the sponsor.
- Related InfoLink provided by the sponsor.
- 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.
Marc Egeth principal investigator
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 Cross Over Assignment Supplemental Oxygen and Supplemental Air in people with Cognition, 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 4 inclusion and 2 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 31 Jan 2025. 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?
2 back Memory test performance (time frame: At baseline and 5 mins post-intervention exposure). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06555484, which also lists 5 linked publications.
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 31 Jan 2025.