Clinical trial NCT06555484: Acute Effects of Supplemental Oxygen on Memory Testing in Healthy Adult Volunteers
Official title: Acute Effects of Supplemental Oxygen on Memory in Healthy Older Adults: a Double-Blind Within-Subject Crossover Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cognition
Keywords: Oxygen Concentrator
Hyperoxia
Lead sponsor: Inogen Inc.
Sponsor class: INDUSTRY
First posted: 2024-08-15
Enrollment: 40
Sex: ALL
Minimum age (years): 22
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Acute effects of oxygen on memory testing in healthy adult volunteers
Primary purpose: BASIC_SCIENCE

Brief 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.

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).

Eligibility criteria: Inclusion Criteria:

Subjects are intended to represent "healthy adults." Patients will include a mix of self-reported gender and ethnic/racial identification.

1. Provision of signed and dated informed consent form
2. Stated willingness to comply with all study procedures and availability for the duration of the study
3. Adult (aged 22+)

Exclusion Criteria:

* 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.

Primary outcomes:
measure: 2 back Memory test performance
timeFrame: At baseline and 5 mins post-intervention exposure
measure: Memory test performance
timeFrame: At baseline and 5 mins post-intervention exposure
Secondary outcomes:
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Two Liberty Place
state: Pennsylvania
Study officials:
affiliation: Inogen Inc.
name: Marc Egeth
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: Chung 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.
citation: McMorris 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.
citation: Sohn 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.
citation: Shaw 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.