Neurological InjuryNCT07537452
Response of the Cardiac Autonomic Control System After Oxygen Therapy 100% in Hyperbaric Environment
An observational study of Neurological Injury, run by Assaf-Harofeh Medical Center at 1 site in Israel.
Trial summary
The purpose of this study is to examine changes in cardiac autonomic nerve system function in patients receiving Hyperbaric oxygen therapy . Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Neurological Injury
- How many people
- 17 participants
- Where
- 1 siteIsrael
- Study dates
- 1 Aug 2018to 1 Jul 2020
- Phase
- Observational
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients who are scheduled to receive a series of treatments at a pressure cell at Assaf Harofeh Hospital
Who may be able to join
- Patients who are scheduled to receive a series of treatments at a pressure cell at Assaf Harofeh Hospital and are willing to participate in the study.
Who cannot join
- Patients who received previous hyperbaric oxygen therapy for any reason during the 6 months prior to inclusion.
- A history of malignancy during the last year of inclusion.
- A pulmonary disease that does not allow the patient to be admitted to a pressure cell (severe emphysema, moderate obstruction) .
- patients that unable to sign informed consent form.
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to examine changes in cardiac autonomic nerve system function in patients receiving Hyperbaric oxygen therapy .
Read the detailed description
Effects of hyperbaric environment treatment Hyperbaric oxygen therapy (A pressure chamber) is used to treat various conditions in which there is tissue ischemia (a hard wound healing, radiation damage) and in situations where there are air bubbles that should be reduced (decompression - diving accidents, air embolism). Studies from recent years show that hyperbaric oxygen therapy can stimulate brain neuropathy in patients after a stroke and head trauma. Clinically, the evaluation to date includes motor tests and cognitive tests.
The hyperbolic influence on the cardiac autonomic nerve system in healthy subjects is reflected in an increase in activity in the parasympathetic subsystem. The effect of hyperbaric oxygen therapy (100% increase in environmental pressure with oxygen) on autonomic system activity has not yet been tested in patients receiving a series of pressure cell treatments.
The purpose of this study is to examine changes in autonomic system function in patients receiving Hyperbaric oxygen therapy .
After signing the Informed Consent Form, they will be asked to be examined at four time periods: about two weeks before starting treatment, six weeks after starting treatment, last week for the treatment series (if the treatment continues for more than 6 weeks / 30 weeks) and about one month after treatment ends.
Each time the subject is connected to a Polar clock and a breathing strip. An hour-long test will be conducted during which the subjects will be asked to perform:
- Grip Test Breathing Test - Breathing test in which the subject is required to take 6 breaths per minute.
- Cognitive sitting task - subtracting serial number 3 from a random number in the 100 s). The subject was given a three-digit number and for a whole minute he had to miss each time by jumping three.
- Motor task - standing from sitting to standing.
- Performing a motor task + a cognitive task
A 5-10 minute rest will be given between the various tests.
- Conditions
- Neurological Injury
- Medical subject headings
- Trauma, Nervous System
What is being measured
The primary outcome is the main question the study is designed to answer.
Heart Rate Variability- Time messurment
the square Root of the Mean Square successive RR differences(RMSSD) , Mean RR- Mean of R-R intervals.
Measured: 3 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2026
- Study start1 Aug 2018
- Primary completion1 Jul 2020
- Study completion1 Jul 2020
Why it stopped: difficulties in recruiting.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neurological InjuryStudies 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assaf-Harofeh Medical Center
- Sponsor type
- Other government
- Collaborators
- Ariel University
- Responsible party
- Sponsor
- Investigators
- Shay Efrati, Prof, Principal investigator, Asaf-Harofhe MC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07537452
- Sponsor's protocol ID
- 0305-17
- Status last verified
- Jun 2024
- First submitted
- 2 Jul 2019
- Last updated
- 17 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 17 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Response of the Cardiac Autonomic Control System After Oxygen Therapy 100% in Hyperbaric Environment
- ClinicalTrials.gov ID
- NCT07537452
- Acronym / sponsor ID
- 0305-17
- Conditions
- Neurological Injury
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: difficulties in recruiting.
- Enrolment
- 17 participants (actual)
- Lead sponsor
- Assaf-Harofeh Medical CenterOther government
- Collaborators
- Ariel University
- Study start
- 1 Aug 2018 (actual)
- Primary completion
- 1 Jul 2020 (actual)
- Study completion
- 1 Jul 2020 (actual)
- First posted
- 17 Apr 2026 (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 purpose of this study is to examine changes in cardiac autonomic nerve system function in patients receiving Hyperbaric oxygen therapy .
Detailed description
Effects of hyperbaric environment treatment Hyperbaric oxygen therapy (A pressure chamber) is used to treat various conditions in which there is tissue ischemia (a hard wound healing, radiation damage) and in situations where there are air bubbles that should be reduced (decompression - diving accidents, air embolism). Studies from recent years show that hyperbaric oxygen therapy can stimulate brain neuropathy in patients after a stroke and head trauma. Clinically, the evaluation to date includes motor tests and cognitive tests.
The hyperbolic influence on the cardiac autonomic nerve system in healthy subjects is reflected in an increase in activity in the parasympathetic subsystem. The effect of hyperbaric oxygen therapy (100% increase in environmental pressure with oxygen) on autonomic system activity has not yet been tested in patients receiving a series of pressure cell treatments.
The purpose of this study is to examine changes in autonomic system function in patients receiving Hyperbaric oxygen therapy .
After signing the Informed Consent Form, they will be asked to be examined at four time periods: about two weeks before starting treatment, six weeks after starting treatment, last week for the treatment series (if the treatment continues for more than 6 weeks / 30 weeks) and about one month after treatment ends.
Each time the subject is connected to a Polar clock and a breathing strip. An hour-long test will be conducted during which the subjects will be asked to perform:
- Grip Test Breathing Test - Breathing test in which the subject is required to take 6 breaths per minute.
- Cognitive sitting task - subtracting serial number 3 from a random number in the 100 s). The subject was given a three-digit number and for a whole minute he had to miss each time by jumping three.
- Motor task - standing from sitting to standing.
- Performing a motor task + a cognitive task
A 5-10 minute rest will be given between the various tests.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who are scheduled to receive a series of treatments at a pressure cell at Assaf Harofeh Hospital
Key inclusion criteria (1 listed)
- Patients who are scheduled to receive a series of treatments at a pressure cell at Assaf Harofeh Hospital and are willing to participate in the study.
Key exclusion criteria (4 listed)
- Patients who received previous hyperbaric oxygen therapy for any reason during the 6 months prior to inclusion.
- A history of malignancy during the last year of inclusion.
- A pulmonary disease that does not allow the patient to be admitted to a pressure cell (severe emphysema, moderate obstruction) .
- patients that unable to sign informed consent form.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Heart Rate Variability- Time messurment
Time frame: 3 month
the square Root of the Mean Square successive RR differences(RMSSD) , Mean RR- Mean of R-R intervals.
Results and safety
The study was stopped early (reason given: difficulties in recruiting.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 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.
Shay Efrati, Prof 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?
An observational study of Neurological Injury, 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 1 inclusion and 4 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: stopped early, as of the sponsor's last update on 17 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. 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 was stopped early (reason given: difficulties in recruiting.). Results are not available in the source record.
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?
Heart Rate Variability- Time messurment (time frame: 3 month). 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 17 Apr 2026.