Measuring Cognitive Enhancement During Hyperbaric Oxygen Treatments
NCT ID: NCT04358796
Last Updated: 2020-04-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
69 participants
INTERVENTIONAL
2017-11-10
2018-11-02
Brief Summary
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Participants were randomized to perform cognitive tasks in one of two chambers with two different clinical environments: (a) HBOT condition: (2 ATA (atmosphere absolute) 100% oxygen for 90 minutes). (b) Control condition: in which the chamber was not pressurized (Normobaric condition- 1 ATA for 90 minutes).
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Detailed Description
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Participants were recruited through ads on the internet and on student social groups. All participants underwent a comprehensive physical and neurological examination, and general medical conditions were ruled out. Participants were excluded if reported changes in their cognitive or behavioral functions during one month prior to the beginning of the study. Smokers (people who smoke more than seven cigarettes a week) were required to take a lung x-ray confirming there isn't a pulmonary pathology, such as pneumothorax, pulmonary bullae, emphysema, or other lung pathologies preventing them from staying in a high ATA environment. Participants with an abnormal x-ray were excluded from the study. Participants who regularly use Methylphenidate (i.e. Ritalin) or other stimulants for attention disorders (i.e. ADHD) were instructed not to take it at the day of the experiment.
Following consent, all the participants were exposed to the testing battery in a group setting. One of the experimenters went through each of the sub-tests instructions in a detailed manner prior to a practice phase in which participants trained on the tasks. Afterwards, participants were randomized to perform the tasks in one of two chambers with two different clinical environments: (a) HBOT condition: (2 ATA 100% oxygen for 90 minutes). The atmospheric pressure in this condition was set to 2 ATA. This ATA level is known to have a clinical effect, whereas higher-pressure levels may result in inhibitory brain effects or even lead to focal toxicity (Efrati and Ben-Jacob, 2014). (b) Control condition: in which the chamber was not pressurized (Normobaric condition- 1 ATA for 90 minutes) and participants breathed air (21% oxygen). In this condition, ATA was elevated for a few minutes to 1.2 ATA in order to mimic the feeling of pressure building up in the ears. The pressure was decreased soon after to 1 ATA.
The assessment began 30 min after participants wore the oxygen masks within the chamber, in order to enable appropriate brain oxygenation in the HBOT condition (Vadas et al., 2017). The battery was composed of cognitive tests adapted for high functioning subjects and adjusted to an in-chamber group administration setting.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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HBOT environment
Cognitive testing in 2ATA, 100% oxygen in breathing-masks
Hyperbaric oxygent treatment
Subjects will enter the oxygen chamber. ATA will be elevated to 2 ATA. They will breath 100% oxygen while solving cognitive tests designed to assess their cognitive capacities
Control environment
Cognitive testing in 1ATA, air in breathing-masks
Control hyperbaric oxygen treatment
Subjects will enter the oxygen chamber. ATA will be elevated to 1.2 ATA for a short while and the decreased back to 1 ATA. They will breath air while solving cognitive tests designed to assess their cognitive capacities
Interventions
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Hyperbaric oxygent treatment
Subjects will enter the oxygen chamber. ATA will be elevated to 2 ATA. They will breath 100% oxygen while solving cognitive tests designed to assess their cognitive capacities
Control hyperbaric oxygen treatment
Subjects will enter the oxygen chamber. ATA will be elevated to 1.2 ATA for a short while and the decreased back to 1 ATA. They will breath air while solving cognitive tests designed to assess their cognitive capacities
Eligibility Criteria
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Inclusion Criteria
* intact sight / corrected sight
* Hebrew as mother tongue
* Intact comprehension
Exclusion Criteria
* If Had been treated with HBOT for any other reason prior to their inclusion;
* Chest pathology ;
* Inner ear disease;
* Claustrophobia;
20 Years
40 Years
ALL
Yes
Sponsors
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Assaf-Harofeh Medical Center
OTHER_GOV
Responsible Party
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Prof. Shay Efrati
Medical Director of the Sagol Center for Hyperbaric Medicine
Principal Investigators
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Shay Efrati
Role: STUDY_DIRECTOR
Assaf-Harofeh Medical Center
Locations
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Assaf Harofeh Medical Center
Ẕerifin, , Israel
Countries
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Other Identifiers
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0031-17-ASF
Identifier Type: -
Identifier Source: org_study_id
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