Hyperbaric Oxygen TherapyNCT04358796
Measuring Cognitive Enhancement During Hyperbaric Oxygen Treatments
A study testing Hyperbaric oxygent treatment in people with Hyperbaric Oxygen Therapy, run by Assaf-Harofeh Medical Center at 1 site in Israel.
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. Read more about this study
- Who is it for?
- Ages 20 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Hyperbaric Oxygen Therapy
- What is being tested?
- Hyperbaric oxygent treatment
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 69 participants
- Where
- 1 siteIsrael
- Study dates
- 10 Nov 2017to 2 Nov 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age 20-40
- intact sight / corrected sight
- Hebrew as mother tongue
- Intact comprehension
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
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).
Read the detailed 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.
- Conditions
- Hyperbaric Oxygen Therapy
- Being tested
- Hyperbaric oxygent treatment, Control hyperbaric oxygen treatment
- Keywords
- Cognitive enhancement, Memory, Information processing speed, Hyperbaric oxygen treatments
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hyperbaric oxygent treatmentDevice
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 treatmentDevice
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
| Study group | Role | What they receive |
|---|---|---|
| HBOT environment | Experimental | Cognitive testing in 2ATA, 100% oxygen in breathing-masks Receives: Device: Hyperbaric oxygent treatment |
| Control environment | Sham comparator | Cognitive testing in 1ATA, air in breathing-masks Receives: Device: Control hyperbaric oxygen treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
memory
Number of words retrieved from a list
Measured: after 20 minutes of intervention
Working memory
accuracy rates on a working memory paradigm (n-back)
Measured: after 20 minutes of intervention
Divided attention
accuracy rates on a divided attention task (identifying visual and auditory targets)
Measured: after 20 minutes of intervention
Information processing speed
Accuracy rates on an information processing speed task (Symbol tracing task)
Measured: after 20 minutes of intervention
Response inhibition
Accuracy rates on a response inhibition task (stroop)
Measured: after 20 minutes of intervention
Problem solving
accuracy rates on a problem solving task (solving arithmetic series)
Measured: after 20 minutes of intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2020
- Study start10 Nov 2017
- Primary completion2 Nov 2018
- Study completion2 Nov 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hyperbaric Oxygen TherapyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- two groups being tested in parallel. The first group in HBOT environment. The second group in a SHAM environment.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 69 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assaf-Harofeh Medical Center
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Prof. Shay Efrati, Assaf-Harofeh Medical Center
- Investigators
- Shay Efrati, Study director, Assaf-Harofeh Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04358796
- Sponsor's protocol ID
- 0031-17-ASF
- Status last verified
- Apr 2020
- First submitted
- 9 Feb 2020
- Last updated
- 24 Apr 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Measuring Cognitive Enhancement During Hyperbaric Oxygen Treatments
- ClinicalTrials.gov ID
- NCT04358796
- Acronym / sponsor ID
- 0031-17-ASF
- Conditions
- Hyperbaric Oxygen Therapy
- Keywords
- Cognitive enhancement, Memory, Information processing speed, Hyperbaric oxygen treatments
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 69 participants (actual)
- Lead sponsor
- Assaf-Harofeh Medical CenterOther government
- Study start
- 10 Nov 2017 (actual)
- Primary completion
- 2 Nov 2018 (actual)
- Study completion
- 2 Nov 2018 (actual)
- First posted
- 24 Apr 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- two groups being tested in parallel. The first group in HBOT environment. The second group in a SHAM environment.
| Arm | Type | Receives |
|---|---|---|
| HBOT environment | Experimental | Device: Hyperbaric oxygent treatmentCognitive testing in 2ATA, 100% oxygen in breathing-masks |
| Control environment | Sham comparator | Device: Control hyperbaric oxygen treatmentCognitive testing in 1ATA, air in breathing-masks |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Age 20-40
- intact sight / corrected sight
- Hebrew as mother tongue
- Intact comprehension
Key exclusion criteria (5 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hyperbaric oxygent treatmentSubjects 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 | Device | HBOT environment |
| Control hyperbaric oxygen treatmentSubjects 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 | Device | Control environment |
Primary outcome
memory
Time frame: after 20 minutes of intervention
Number of words retrieved from a list
Working memory
Time frame: after 20 minutes of intervention
accuracy rates on a working memory paradigm (n-back)
Divided attention
Time frame: after 20 minutes of intervention
accuracy rates on a divided attention task (identifying visual and auditory targets)
Information processing speed
Time frame: after 20 minutes of intervention
Accuracy rates on an information processing speed task (Symbol tracing task)
Response inhibition
Time frame: after 20 minutes of intervention
Accuracy rates on a response inhibition task (stroop)
Problem solving
Time frame: after 20 minutes of intervention
accuracy rates on a problem solving task (solving arithmetic series)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2020.
- Individual participant dataSharing planned: No
Related trials for Hyperbaric Oxygen Therapy
Not yet recruitingObservational study
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Hyperbaric Oxygen Therapy for Ulcerative Colitis (HBOT-UC)
Ulcerative Colitis
Recruiting
The Impact of Hyperbaric Oxygen Therapy on Vocal Performance in Professional Singers
Vocal Cord Strain (Disorder)
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Hyperbaric Oxygen Therapy for Optic Neuropathies
Optic Neuropathy, Glaucoma
Not yet recruiting
AI-Assisted Precision Hyperbaric Oxygen Therapy Based on Dynamic BIS-EEG Feedback for Patients With Disorders of Consciousness
Disorders of Consciousness, Vegetative State
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Shay Efrati study director
Assaf-Harofeh Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hyperbaric oxygent treatment in people with Hyperbaric Oxygen Therapy, run by Assaf-Harofeh Medical Center at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
memory (time frame: after 20 minutes of intervention). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Apr 2020.