Measuring Cognitive Enhancement During Hyperbaric Oxygen Treatments

Hyperbaric Oxygen Therapy Clinical Trial

Official title:

Measuring Cognitive Enhancement During Hyperbaric Oxygen Treatments

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04358796
• Other study ID #: 0031-17-ASF
• Status: Completed
• Phase: N/A
• Start date: November 10, 2017
• Est. completion date: November 2, 2018

Study information

• Verified date: April 2020
• Source: Assaf-Harofeh Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 69
• Est. completion date: November 2, 2018
• Est. primary completion date: November 2, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 40 Years

Eligibility

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;

Related Conditions & MeSH terms

• Hyperbaric Oxygen Therapy

Intervention

Device:
• 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

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	memory	Number of words retrieved from a list	after 20 minutes of intervention
Primary	Working memory	accuracy rates on a working memory paradigm (n-back)	after 20 minutes of intervention
Primary	Divided attention	accuracy rates on a divided attention task (identifying visual and auditory targets)	after 20 minutes of intervention
Primary	Information processing speed	Accuracy rates on an information processing speed task (Symbol tracing task)	after 20 minutes of intervention
Primary	Response inhibition	Accuracy rates on a response inhibition task (stroop)	after 20 minutes of intervention
Primary	Problem solving	accuracy rates on a problem solving task (solving arithmetic series)	after 20 minutes of intervention