Acute Effects of Supplemental Oxygen on Memory Testing in Healthy Adult Volunteers

January 30, 2025 updated by: Inogen Inc.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19102
        • Two Liberty Place

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Air First
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
Subjects repeatedly complete memory tests, either first while breathing supplemental oxygen or first while breathing "supplemental air" (in an order randomly assigned).
Other: Oxygen First
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
Subjects repeatedly complete memory tests, either first while breathing supplemental oxygen or first while breathing "supplemental air" (in an order randomly assigned).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
2 back Memory test performance
Time Frame: At baseline and 5 mins post-intervention exposure
# correct on 2-back test
At baseline and 5 mins post-intervention exposure
Memory test performance
Time Frame: At baseline and 5 mins post-intervention exposure
New Medical Icons Spatial Test
At baseline and 5 mins post-intervention exposure

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Inogen Inc.

Investigators

  • Principal Investigator: Marc Egeth, Inogen Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 28, 2024

Primary Completion (Actual)

October 31, 2024

Study Completion (Actual)

October 31, 2024

Study Registration Dates

First Submitted

July 27, 2024

First Submitted That Met QC Criteria

August 12, 2024

First Posted (Actual)

August 15, 2024

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

January 30, 2025

Last Verified

January 1, 2025

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • INO-06

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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