Hyperbaric OxygenationHBOTNCT07596641
Retrospective Analysis of CPET and Cognitive Tests of Healthy Individuals, Treated With 60 Treatment of HBOT
An observational study of Hyperbaric Oxygenation and Cardiorespiratory Fitness, run by Assaf-Harofeh Medical Center.
Trial summary
This retrospective observational study evaluates physiological and cognitive changes following a series of 60 hyperbaric oxygen therapy (HBOT) sessions in healthy individuals. Participants underwent treatment five days per week, each session included 90 minutes exposure to 100% oxygen at 2ATA with a five-minute air… Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Hyperbaric Oxygenation, Cardiorespiratory Fitness, Cognition
- What is being tested?
- Hyperbaric Oxygen Therapy - HBOT
- How many people
- 1,000 participants
- Where
- No sites listed yet
- Study dates
- 1 Dec 2026to 30 Mar 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: This retrospective cohort includes adults treated at the Sagol Center who completed a full course of 60 hyperbaric oxygen therapy sessions. All participants underwent pre- and post-treatment cardiopulmonary exercise testing and standardized cognitive evaluations as part of routine clinical care. Data were extracted from institutional clinical databases for retrospective analysis.
Who may be able to join
- Adults aged 18-65 years
- Completed a full treatment series of 60 hyperbaric oxygen therapy (HBOT) sessions at the Sagol Center
- Availability of pre- and post-treatment cardiopulmonary exercise testing (CPET) data
- Availability of pre- and post-treatment cognitive assessment data
Who cannot join
- Inability to complete a maximal CPET test, pre and post HBOT or Missing pre- or post-treatment CPET data.
- Incomplete HBOT treatment series
- Missing cognitive assessment data
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Retrospective Analysis of Cardiopulmonary Exercise Tests and Cognitive Tests of Healthy Individuals Age 18+ Years, Treated at the Sagol Center for Hyperbaric Medicine and Research With 60 Hyperbaric Oxygen Therapy Treatments.
This retrospective observational study evaluates physiological and cognitive changes following a series of 60 hyperbaric oxygen therapy (HBOT) sessions in healthy individuals. Participants underwent treatment five days per week, each session included 90 minutes exposure to 100% oxygen at 2ATA with a five-minute air break every 20 minutes. Pre- and post-treatment data include cardiopulmonary exercise testing (CPET) and standardized cognitive assessments. The study aims to characterize associations between changes in cardiorespiratory fitness and cognitive performance following repeated HBOT exposure in a real-world clinical cohort
Read the detailed description
This retrospective observational study analyzes data collected from healthy adults who completed a full treatment series of 60 hyperbaric oxygen therapy (HBOT) sessions at the Sagol Center for Hyperbaric Medicine and Research. Each session included 90 minutes exposure to 100% oxygen at 2ATA with a five-minute air break every 20 minutes
The primary objective is to evaluate physiological adaptations to repeated HBOT exposure using cardiopulmonary exercise testing (CPET) metrics, including aerobic capacity and exercise performance parameters. A secondary objective is to examine concurrent changes in cognitive function as assessed by standardized neurocognitive testing performed as part of routine clinical evaluation.
The study utilizes de-identified data extracted from clinical records and institutional databases. As a retrospective analysis, no intervention or allocation was performed for research purposes. The study aims to explore potential relationships between changes in physical performance and cognitive outcomes following HBOT in in a real-world clinical cohort
- Conditions
- Hyperbaric Oxygenation, Cardiorespiratory Fitness, Cognition
- Being tested
- Hyperbaric Oxygen Therapy - HBOT
- Keywords
- HBOT, VO2MAX, VO2 PEAK, cognitive function, CPET, cardiopulmonary exercise testing, hyperbaric oxygen therapy, HEALTH
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hyperbaric Oxygen Therapy - HBOTOther
60 consecutive hyperbaric oxygen treatment (HBOT) sessions, 5 sessions per week within a three months' period
| Study group | Role | What they receive |
|---|---|---|
| Adults Treated With HBOT | Retrospective cohort of adults who completed a full treatment series of 60 hyperbaric oxygen therapy (HBOT) sessions at 2 atmospheres absolute (ATA) breathing 100% oxygen, and were approved for a maximal cardiopulmonary exercise testing (CPET). Prticipants underwent pre- and post-treatment cardiopulmonary exercise testing (CPET) and cognitive assessments as part of routine clinical evaluation. Receives: Other: Hyperbaric Oxygen Therapy - HBOT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Exercise Duration During CPET
Total duration the participant is able to continue the cardiopulmonary exercise testing (CPET) protocol until voluntary exhaustion or termination criteria are reached.
Unit of Measure: Minutes
Measured: Baseline and post-treatment (approximately 4-6 months)
Peak Workload During CPET
Highest external work rate achieved during CPET on a cycle ergometer.
Unit of Measure: Watts (W)
Measured: Baseline and post-treatment (approximately 4-6 months)
Peak Metabolic Equivalent (METs) During CPET
Highest metabolic equivalent level achieved during treadmill-based CPET.
Unit of Measure: METs
Measured: Baseline and post-treatment (approximately 4-6 months)
Ventilatory Threshold Oxygen Uptake (VT1/VT2)
Oxygen uptake measured at ventilatory thresholds (VT1 and VT2) during CPET, reflecting metabolic transition during exercise. Unit of Measure: mL/kg/min
Measured: Baseline and post-treatment (approximately 4-6 months)
Ventilatory Threshold Workload
Workload achieved at ventilatory thresholds (VT1 and VT2) during CPET.
Unit of Measure: Watts (W)
Measured: Baseline and post-treatment (approximately 4-6 months)
Ventilatory Threshold Heart Rate
Heart rate recorded at ventilatory thresholds (VT1 and VT2) during CPET. Unit of Measure: Beats per minute (bpm)
Measured: Baseline and post-treatment (approximately 4-6 months)
Time to Ventilatory Threshold
Elapsed exercise time at which ventilatory thresholds (VT1 and VT2) are reached during CPET. Unit of Measure: Minutes
Measured: Baseline and post-treatment (approximately 4-6 months)
Secondary outcomes (1)
Change in Cognitive Function Following Hyperbaric Oxygen Therapy
Change in standardized cognitive performance scores measured before and after completion of 60 hyperbaric oxygen therapy sessions using NeuroTrax cognitive battery test.
Measured: Baseline and post-treatment (approximately 4-6 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2026
- Study start1 Dec 2026 (estimated)
- Primary completion1 Dec 2027 (estimated)
- Study completion30 Mar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hyperbaric OxygenationStudies 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assaf-Harofeh Medical Center
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07596641
- Sponsor's protocol ID
- 0262-24 ASF
- Acronym
- HBOT
- Status last verified
- Feb 2026
- First submitted
- 16 Apr 2026
- Last updated
- 19 May 2026
- 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 19 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Retrospective Analysis of Cardiopulmonary Exercise Tests and Cognitive Tests of Healthy Individuals Age 18+ Years, Treated at the Sagol Center for Hyperbaric Medicine and Research With 60 Hyperbaric Oxygen Therapy Treatments.
- ClinicalTrials.gov ID
- NCT07596641
- Acronym / sponsor ID
- HBOT / 0262-24 ASF
- Conditions
- Hyperbaric Oxygenation, Cardiorespiratory Fitness, Cognition
- Keywords
- HBOT, VO2MAX, VO2 PEAK, cognitive function, CPET, cardiopulmonary exercise testing, hyperbaric oxygen therapy, HEALTH
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Assaf-Harofeh Medical CenterOther government
- Study start
- 1 Dec 2026 (estimated)
- Primary completion
- 1 Dec 2027 (estimated)
- Study completion
- 30 Mar 2028 (estimated)
- First posted
- 19 May 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.
This retrospective observational study evaluates physiological and cognitive changes following a series of 60 hyperbaric oxygen therapy (HBOT) sessions in healthy individuals. Participants underwent treatment five days per week, each session included 90 minutes exposure to 100% oxygen at 2ATA with a five-minute air break every 20 minutes. Pre- and post-treatment data include cardiopulmonary exercise testing (CPET) and standardized cognitive assessments. The study aims to characterize associations between changes in cardiorespiratory fitness and cognitive performance following repeated HBOT exposure in a real-world clinical cohort
Detailed description
This retrospective observational study analyzes data collected from healthy adults who completed a full treatment series of 60 hyperbaric oxygen therapy (HBOT) sessions at the Sagol Center for Hyperbaric Medicine and Research. Each session included 90 minutes exposure to 100% oxygen at 2ATA with a five-minute air break every 20 minutes
The primary objective is to evaluate physiological adaptations to repeated HBOT exposure using cardiopulmonary exercise testing (CPET) metrics, including aerobic capacity and exercise performance parameters. A secondary objective is to examine concurrent changes in cognitive function as assessed by standardized neurocognitive testing performed as part of routine clinical evaluation.
The study utilizes de-identified data extracted from clinical records and institutional databases. As a retrospective analysis, no intervention or allocation was performed for research purposes. The study aims to explore potential relationships between changes in physical performance and cognitive outcomes following HBOT in in a real-world clinical cohort
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Adults Treated With HBOT | – | Other: Hyperbaric Oxygen Therapy - HBOTRetrospective cohort of adults who completed a full treatment series of 60 hyperbaric oxygen therapy (HBOT) sessions at 2 atmospheres absolute (ATA) breathing 100% oxygen, and were approved for a maximal cardiopulmonary exercise testing (CPET). Prticipants underwent pre- and post-treatment cardiopulmonary exercise testing (CPET) and cognitive assessments as part of routine clinical evaluation. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- This retrospective cohort includes adults treated at the Sagol Center who completed a full course of 60 hyperbaric oxygen therapy sessions. All participants underwent pre- and post-treatment cardiopulmonary exercise testing and standardized cognitive evaluations as part of routine clinical care. Data were extracted from institutional clinical databases for retrospective analysis.
Key inclusion criteria (4 listed)
- Adults aged 18-65 years
- Completed a full treatment series of 60 hyperbaric oxygen therapy (HBOT) sessions at the Sagol Center
- Availability of pre- and post-treatment cardiopulmonary exercise testing (CPET) data
- Availability of pre- and post-treatment cognitive assessment data
Key exclusion criteria (3 listed)
- Inability to complete a maximal CPET test, pre and post HBOT or Missing pre- or post-treatment CPET data.
- Incomplete HBOT treatment series
- Missing cognitive assessment data
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 Oxygen Therapy - HBOT60 consecutive hyperbaric oxygen treatment (HBOT) sessions, 5 sessions per week within a three months' period | Other | Adults Treated With HBOT |
Primary outcome
Exercise Duration During CPET
Time frame: Baseline and post-treatment (approximately 4-6 months)
Total duration the participant is able to continue the cardiopulmonary exercise testing (CPET) protocol until voluntary exhaustion or termination criteria are reached. Unit of Measure: Minutes
Peak Workload During CPET
Time frame: Baseline and post-treatment (approximately 4-6 months)
Highest external work rate achieved during CPET on a cycle ergometer. Unit of Measure: Watts (W)
Peak Metabolic Equivalent (METs) During CPET
Time frame: Baseline and post-treatment (approximately 4-6 months)
Highest metabolic equivalent level achieved during treadmill-based CPET. Unit of Measure: METs
Ventilatory Threshold Oxygen Uptake (VT1/VT2)
Time frame: Baseline and post-treatment (approximately 4-6 months)
Oxygen uptake measured at ventilatory thresholds (VT1 and VT2) during CPET, reflecting metabolic transition during exercise. Unit of Measure: mL/kg/min
Ventilatory Threshold Workload
Time frame: Baseline and post-treatment (approximately 4-6 months)
Workload achieved at ventilatory thresholds (VT1 and VT2) during CPET. Unit of Measure: Watts (W)
Ventilatory Threshold Heart Rate
Time frame: Baseline and post-treatment (approximately 4-6 months)
Heart rate recorded at ventilatory thresholds (VT1 and VT2) during CPET. Unit of Measure: Beats per minute (bpm)
Time to Ventilatory Threshold
Time frame: Baseline and post-treatment (approximately 4-6 months)
Elapsed exercise time at which ventilatory thresholds (VT1 and VT2) are reached during CPET. Unit of Measure: Minutes
1 secondary outcome
Change in Cognitive Function Following Hyperbaric Oxygen Therapy
Time frame: Baseline and post-treatment (approximately 4-6 months)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 May 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.
Questions about this trial
What is this clinical trial studying?
An observational study of Hyperbaric Oxygenation and Cardiorespiratory Fitness, run by Assaf-Harofeh Medical Center.
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 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: opening soon, as of the sponsor's last update on 19 May 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Eldad Mr Yaakobo, Ms (+972542092860, yaakobi.eldad@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Exercise Duration During CPET (time frame: Baseline and post-treatment (approximately 4-6 months)). The study lists 7 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 19 May 2026.