- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03126669
Oxygen as a Limiting Factor for Performing Multitasking
Oxygen as a Limiting Factor for Performing Multitasking: Functional Evaluation Under Normobaric and Hyperbaric Oxygenation of Healthy Participants
The Brain uses 20% of the total oxygen supply consumed by the entire body. Even though, less than 10% of the brain is active at every given time, the brain utilizes almost all the oxygen delivered. In order to perform different tasks or more than one task (multi-tasking), the oxygen supply is shifted from one brain region to another, via modulation of blood perfusion.
The aim of the present study was to evaluate whether hyperbaric oxygen (HBO) environment, with increased oxygen supply to the brain, will enable better performance of complex and/or multiple activities.
Methods: a prospective, double blind randomized control, cross over trial including healthy volunteers. Participants were asked to perform a cognitive task, a motor task and a simultaneous cognitive-motor task (multi-tasking). Participants were randomized to perform the tasks at 2 environments: (a) normobaric air (1ATA 21% oxygen) (b) HBO (2ATA 100% oxygen). Two weeks later participants were crossed to the alternative environment. Blinding of the normobaric environment was achieved in the same chamber with masks on while hyperbaric sensation was simulated by increasing pressure in the first minute and gradually decreasing to normobaric environment prior to tasks performance.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Zerifin, Israel, 70300
- Assaf-Harofeh Medical Center
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- healthy volunteers,
- minimum of 12 years of formal education
Exclusion Criteria:
- any inner ear pathologies,
- any lung disease,
- any mental or physical limitation of participat in going into oxygen chamber environment
Study Plan
How is the study designed?
Design Details
- Primary Purpose: SUPPORTIVE_CARE
- Allocation: RANDOMIZED
- Interventional Model: CROSSOVER
- Masking: SINGLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
ACTIVE_COMPARATOR: Treratment
100% oxygen at 2 ATA at the hyperbaric chamber
|
Breathing 100% oxygen at 2ATA in the hyperbaric chamber
|
PLACEBO_COMPARATOR: Placebo
normal air, in the hyperbaric chamber
|
Hyperbaric chamber with normal air
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Cognitive/Attention Symbol-Digit Modality Test (SDMT)
Time Frame: 45 minutes
|
Three different forms of the SDMT were used in each evaluation session.
The first was a try-out for the test, ensuring understanding of the task.
The second tests the ability to per-form an individual task.
The third form was used together with the motor test for examin-ing dual task performance.
Standard administration procedures were followed as indicat-ed in the test manual.
The score of the test is the number of correct substitutions during 90-second interval.
|
45 minutes
|
Motor task: transferring of beans
Time Frame: 45 minutes
|
Motor performance was evaluated by the Motor Assessment Scale test (MAS) - transfer-ring units of beans one by one between two tea cups an arm length away.
|
45 minutes
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 213/13
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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