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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03126669
Other study ID # 213/13
Secondary ID
Status Completed
Phase N/A
First received April 20, 2017
Last updated January 15, 2018
Start date November 1, 2014
Est. completion date March 25, 2017

Study information

Verified date April 2017
Source Assaf-Harofeh Medical Center
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Recruitment information / eligibility

Status Completed
Enrollment 24
Est. completion date March 25, 2017
Est. primary completion date November 30, 2016
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Device:
Hyperbaric oxygen
Breathing 100% oxygen at 2ATA in the hyperbaric chamber
Hyperbaric chamber, normal air
Hyperbaric chamber with normal air

Locations

Country Name City State
Israel Assaf-Harofeh Medical Center Zerifin

Sponsors (1)

Lead Sponsor Collaborator
Assaf-Harofeh Medical Center

Country where clinical trial is conducted

Israel, 

Outcome

Type Measure Description Time frame Safety issue
Primary Cognitive/Attention Symbol-Digit Modality Test (SDMT) 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
Primary Motor task: transferring of beans 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
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