Cognitive ChangeNCT03126669
Oxygen as a Limiting Factor for Performing Multitasking
A study testing Hyperbaric oxygen and Hyperbaric chamber, normal air in people with Cognitive Change, run by Assaf-Harofeh Medical Center at 1 site in Israel.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cognitive Change
- What is being tested?
- Hyperbaric oxygen and Hyperbaric chamber, normal air
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- 1 siteIsrael
- Study dates
- 1 Nov 2014to 25 Mar 2017
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- healthy volunteers,
- minimum of 12 years of formal education
Who cannot join
- any inner ear pathologies,
- any lung disease,
- any mental or physical limitation of participat in going into oxygen chamber environment
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Oxygen as a Limiting Factor for Performing Multitasking: Functional Evaluation Under Normobaric and Hyperbaric Oxygenation of Healthy Participants
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.
Read the detailed description
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.
- Conditions
- Cognitive Change
- Being tested
- Hyperbaric oxygen, Hyperbaric chamber, normal air
- Keywords
- Hyperbaric oxygen, multitasking performance, cognitive funcitons
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hyperbaric oxygenDevice
Breathing 100% oxygen at 2ATA in the hyperbaric chamber
Hyperbaric chamber, normal airDevice
Hyperbaric chamber with normal air
| Study group | Role | What they receive |
|---|---|---|
| Treratment | Active comparator | 100% oxygen at 2 ATA at the hyperbaric chamber Receives: Device: Hyperbaric oxygen |
| Placebo | Placebo comparator | normal air, in the hyperbaric chamber Receives: Device: Hyperbaric chamber, normal air |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 45 minutes
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.
Measured: 45 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2017
- Study start1 Nov 2014
- Primary completion30 Nov 2016
- Study completion25 Mar 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cognitive ChangeStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assaf-Harofeh Medical Center
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Shai a Efrati, MD, Principal investigator, Asaf-Harofhe MC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03126669
- Sponsor's protocol ID
- 0213-13
- Status last verified
- Jul 2024
- First submitted
- 20 Apr 2017
- Last updated
- 21 Apr 2026
- Results posted
- No
- Data monitoring committee
- 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 21 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Oxygen as a Limiting Factor for Performing Multitasking: Functional Evaluation Under Normobaric and Hyperbaric Oxygenation of Healthy Participants
- ClinicalTrials.gov ID
- NCT03126669
- Acronym / sponsor ID
- 0213-13
- Conditions
- Cognitive Change
- Keywords
- Hyperbaric oxygen, multitasking performance, cognitive funcitons
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Assaf-Harofeh Medical CenterOther government
- Study start
- 1 Nov 2014 (actual)
- Primary completion
- 30 Nov 2016 (actual)
- Study completion
- 25 Mar 2017 (actual)
- First posted
- 24 Apr 2017 (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 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.
Detailed description
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treratment | Active comparator | Device: Hyperbaric oxygen100% oxygen at 2 ATA at the hyperbaric chamber |
| Placebo | Placebo comparator | Device: Hyperbaric chamber, normal airnormal air, in the hyperbaric chamber |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- healthy volunteers,
- minimum of 12 years of formal education
Key exclusion criteria (3 listed)
- any inner ear pathologies,
- any lung disease,
- any mental or physical limitation of participat in going into oxygen chamber environment
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 oxygenBreathing 100% oxygen at 2ATA in the hyperbaric chamber | Device | Treratment |
| Hyperbaric chamber, normal airHyperbaric chamber with normal air | Device | Placebo |
Primary outcome
Cognitive/Attention Symbol-Digit Modality Test (SDMT)
Time frame: 45 minutes
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.
Motor task: transferring of beans
Time frame: 45 minutes
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.
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 21 Apr 2026.
- Individual participant dataSharing planned: No
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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.
Shai a Efrati, MD principal investigator
Asaf-Harofhe MC
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 oxygen and Hyperbaric chamber, normal air in people with Cognitive Change, 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 2 inclusion and 3 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 21 Apr 2026. 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?
Cognitive/Attention Symbol-Digit Modality Test (SDMT) (time frame: 45 minutes). The study lists 2 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 21 Apr 2026.