NCT05292378

Brief Summary

The purpose of the study is to better understand the biological mechanisms of carbon dioxide (CO2)-induced cognitive impairments.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
27

participants targeted

Target at P25-P50 for not_applicable healthy

Timeline
Completed

Started Jul 2022

Longer than P75 for not_applicable healthy

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

First Submitted

Initial submission to the registry

January 24, 2022

Completed
2 months until next milestone

First Posted

Study publicly available on registry

March 23, 2022

Completed
4 months until next milestone

Study Start

First participant enrolled

July 14, 2022

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 20, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 20, 2025

Completed
12 months until next milestone

Results Posted

Study results publicly available

March 16, 2026

Completed
Last Updated

March 16, 2026

Status Verified

February 1, 2026

Enrollment Period

2.7 years

First QC Date

January 24, 2022

Results QC Date

February 19, 2026

Last Update Submit

February 23, 2026

Conditions

Keywords

Carbon DioxideCognitive Impairment

Outcome Measures

Primary Outcomes (3)

  • Change in PMN (Polymorphonuclear Leukocyte) Activation as Measured by Basal Oxygen Consumption (OCR)

    Using blood samples collected 4 hours post-exposure, PMN activation was assessed by measurement of oxidative burst (oxygen consumption rate).

    4 hours after each exposure

  • Change in PMN (Polymorphonuclear Leukocyte) Activation as Measured by Total Stimulated Oxygen Consumption.

    Using blood samples collected 4 hours post-exposure, PMN activation was assessed by measurement of total stimulated oxygen consumption.

    4 hours after each exposure

  • Change in PMN (Polymorphonuclear Leukocyte) Activation as Measured by Time to Peak (TTP) Oxygen Consumption

    Using blood samples collected 4 hours post-exposure, PMN activation was assessed by measurement of time to peak (TTP) oxygen consumption.

    4 hours after each exposure

Study Arms (2)

High CO2 Exposure first, then low CO2 exposure second.

EXPERIMENTAL

At the first study visit the subject is exposed to 2500 ppm CO2 for 2.5 hours and at the second study visit the subject is exposed to 600 ppm CO2 for 2.5 hours.

Other: 2500 ppm Carbon DioxideOther: 600 ppm Carbon Dioxide

Low CO2 Exposure first, then high CO2 exposure second.

SHAM COMPARATOR

At the first study visit the subject is exposed to 600 ppm CO2 for 2.5 hours and at the second study visit the subject is exposed to 2500 ppm CO2 for 2.5 hours.

Other: 2500 ppm Carbon DioxideOther: 600 ppm Carbon Dioxide

Interventions

2.5 hour exposure to 2500 ppm carbon dioxide

High CO2 Exposure first, then low CO2 exposure second.Low CO2 Exposure first, then high CO2 exposure second.

2.5 hour exposure to 600 ppm carbon dioxide

High CO2 Exposure first, then low CO2 exposure second.Low CO2 Exposure first, then high CO2 exposure second.

Eligibility Criteria

Age18 Years - 30 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • History of COVID-19 vaccination
  • Weigh at least 110 pounds

You may not qualify if:

  • Colorblindness
  • Inability to hear verbal instructions
  • Cardiovascular disease, including a history of stroke
  • Diabetes requiring the use of insulin
  • Pregnancy
  • Current asthma (an asthma attack within the past five years)
  • Medications for or history of anxiety disorder diagnosis or panic attacks
  • Medications which may affect cognition such as beta-blockers and CNS depressants
  • Respiratory symptoms in the previous four weeks
  • Use of sedating cold/allergy medications in the previous week
  • Use of marijuana in the previous week
  • Consumption of alcohol in the previous 24 hours
  • History of head trauma or neurosurgery or neurological disorder
  • Ferrous metal implanted in or on the body, electrical devices such as a pacemaker, nonremovable ferrous jewelry
  • Surgical pins or plates above the neck
  • +5 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rutgers - EOHSI

Piscataway, New Jersey, 08854, United States

Location

MeSH Terms

Conditions

Cognitive Dysfunction

Condition Hierarchy (Ancestors)

Cognition DisordersNeurocognitive DisordersMental Disorders

Results Point of Contact

Title
Howard Kipen
Organization
Rutgers the State University of New Jersey

Study Officials

  • Howard Kipen, MD

    Professor

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

January 24, 2022

First Posted

March 23, 2022

Study Start

July 14, 2022

Primary Completion

March 20, 2025

Study Completion

March 20, 2025

Last Updated

March 16, 2026

Results First Posted

March 16, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will not share

There is no plan to make individual participant data available to other researchers.

Locations