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Measuring Cognitive Enhancement During Hyperbaric Oxygen Treatments

S

Shamir Medical Center (Assaf-Harofeh)

Status

Completed

Conditions

Hyperbaric Oxygen Therapy

Treatments

Device: Control hyperbaric oxygen treatment
Device: Hyperbaric oxygent treatment

Study type

Interventional

Funder types

Other

Identifiers

NCT04358796
0031-17-ASF

Details and patient eligibility

About

The aim of the current study was to examine the effect of short-term HBOT (hyperbaric oxygen treatments) on a range of cognitive abilities. The current study examined whether there is a HBOT-related short-term cognitive improvement and, if so, what specific cognitive abilities are improved by the intervention.

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).

Full description

The aim of the current study was to examine the effect of short-term HBOT on a range of cognitive abilities. The current study examined whether there is a HBOT-related short-term cognitive improvement and, if so, what specific cognitive abilities are improved by the intervention.

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.

Enrollment

69 patients

Sex

All

Ages

20 to 40 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  • Age 20-40
  • intact sight / corrected sight
  • Hebrew as mother tongue
  • Intact comprehension

Exclusion criteria

  • Active neurologic or psychiatric diagnosis.
  • If Had been treated with HBOT for any other reason prior to their inclusion;
  • Chest pathology ;
  • Inner ear disease;
  • Claustrophobia;

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

69 participants in 2 patient groups

HBOT environment
Experimental group
Description:
Cognitive testing in 2ATA, 100% oxygen in breathing-masks
Treatment:
Device: Hyperbaric oxygent treatment
Control environment
Sham Comparator group
Description:
Cognitive testing in 1ATA, air in breathing-masks
Treatment:
Device: Control hyperbaric oxygen treatment

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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