NCT06555484

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 28, 2024

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

July 27, 2024

Completed
19 days until next milestone

First Posted

Study publicly available on registry

August 15, 2024

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 31, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 31, 2024

Completed
Last Updated

January 31, 2025

Status Verified

January 1, 2025

Enrollment Period

5 months

First QC Date

July 27, 2024

Last Update Submit

January 30, 2025

Conditions

Cognition

Keywords

Oxygen ConcentratorHyperoxia

Outcome Measures

Primary Outcomes (2)

  • 2 back Memory test performance

    \# correct on 2-back test

    At baseline and 5 mins post-intervention exposure

  • Memory test performance

    New Medical Icons Spatial Test

    At baseline and 5 mins post-intervention exposure

Study Arms (2)

Air First

OTHER

All study participants, completing memory tests while breathing either supplemental oxygen followed by air, or breathing air followed oxygen.

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.

Device: Cross Over Assignment Supplemental Oxygen and Supplemental Air

Interventions

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).

Air FirstOxygen First

Eligibility Criteria

Age22 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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+)

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Two Liberty Place

Philadelphia, Pennsylvania, 19102, United States

Location

Related Publications (5)

  • 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.

    PMID: 22817401BACKGROUND

  • 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.

    PMID: 17395994BACKGROUND

  • 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.

    PMID: 28111267BACKGROUND

  • 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.

    PMID: 15684544BACKGROUND

  • 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.

    PMID: 37121344BACKGROUND

Related Links

MeSH Terms

Conditions

Hyperoxia

Condition Hierarchy (Ancestors)

Signs and Symptoms, RespiratorySigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Marc Egeth

    Inogen Inc.

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Model Details: Acute effects of oxygen on memory testing in healthy adult volunteers
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 27, 2024

First Posted

August 15, 2024

Study Start

May 28, 2024

Primary Completion

October 31, 2024

Study Completion

October 31, 2024

Last Updated

January 31, 2025

Record last verified: 2025-01

Data Sharing

IPD Sharing
Will not share

Locations

US(1)