AgingANGIOHBOTNCT02790541
Angiogenesis Induced in the Elderly by Hyperbaric Oxygen Therapy
A study testing Hyperbaric Oxygen Therapy in people with Aging, run by Assaf-Harofeh Medical Center at 1 site in Israel.
Trial summary
Recent studies show preliminary evidence of HBOT therapeutic effects on angiogenesis, increased tissue blood flow and oxygenation correlated with tissue function. Our primary hypothesis is that HBOT will have beneficial effects on the above mentioned organs associated with aging-related malfunctions due to restored… Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Aging
- What is being tested?
- Hyperbaric Oxygen Therapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 62 participants
- Where
- 1 siteIsrael
- Study dates
- Dec 2016to Jan 2020
- 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 65 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- Age≥ 65 years
- Capability to sign informed consent.
- No cardiac or cerebrovascular ischemia previous events one year prior to inclusion.
Who cannot join
- Previous treatment with HBOT for any other reason during the last 3 months prior to inclusion.
- Any history of malignancy during the last year prior to inclusion.
- Severe cognitive decline (MMSA<17)
- Severe chronic renal failure (GFR <30)
- Uncontrolled diabetes mellitus (HbA1C>8, fasting glucose>200)
- Immunosuppressant from any reason
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- Contraindications to perform MRI: claustrophobia, allergy to gadolinium, foreign bodies, pacemaker, etc.
- Active Smoking.
- Pulmonary diseases such as severe emphysema, moderate-severe obstructive disease.
- Medical conditions deemed by the investigator to make the patient ineligible for protocol investigations.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Changes in Blood Flow and Angiogenesis Induced in the Elderly by Hyperbaric Oxygen Therapy
Recent studies show preliminary evidence of HBOT therapeutic effects on angiogenesis, increased tissue blood flow and oxygenation correlated with tissue function.
Our primary hypothesis is that HBOT will have beneficial effects on the above mentioned organs associated with aging-related malfunctions due to restored mitochondrial function, mobilization of stem cells and induction of angiogenesis.
Read the detailed description
The paradigm The accumulation of damage to molecules, cells and tissues over a lifetime that contributes to aging eventually leads to frailty and malfunction. The past decade has seen fundamental advances in our understanding of the aging process and raised optimism that interventions to slow ageing may be on the horizon. The aging process is linked to energy deficit due to tissue hypoxia and mitochondria dysfunction.
- Mitochondria dysfunction- Mitochondria are the primary generator of energy by means of ATP synthesis and their dysfunction leads to cellular function decline and degenerative changes. In addition, mitochondria dysfunction in stem cells decreases the capabilities for tissue regeneration.
- Tissue hypoxia- Atherosclerosis is a chronic inflammatory response that damages arterial blood vessels. It begins in childhood and progresses throughout life. A vicious cycle occurs as mitochondrial dysfunction accelerates atherosclerosis and the waning of microvasculature, resulting in decrease blood supply and ensuing relative tissue hypoxia. The decrease oxygen supply to the mitochondria further exacerbates mitochondrial dysfunction.
Hyperbaric oxygen can increase the partial pressure of dissolved (non-hemoglobin-bound) oxygen 20-30 fold and produce two main effects. First, it can eliminate the relative tissue hypoxia induced by atherosclerosis. Second, because mitochondria function is directly influenced by the partial pressure of dissolved oxygen, hyperbaric oxygen can amend mitochondrial dysfunction. Thus, the investigators suggest hyperbaric oxygen as a novel method for breaking the vicious cycle of degeneration and perhaps even for reversing the aging process.
The study is designed as a prospective crossover study aiming to evaluate the therapeutic effects of HBOT on the Brain, Cardiovascular and Immune system, Skin, Erectile (sexual functions), liver and Kidneys, of aging population.
After signing an informed consent form, patients will be invited for baseline evaluations. All patients would be evaluated 3 times - at baseline, after 3 months of follow up, and after additional 3 months of HBOT protocol. The evaluation will include cognitive assessment, questionnaires, MRI scans, blood tests and skin photograph and biopsy. In addition, blood tests will be drawn before and after the 20th, 40th and the 60th sessions for stem cells and mitochondria tests.
Patients will receive 60 daily sessions, 5 days/week, 90 minutes each with 5 minutes air break every 30 minutes, 100% oxygen at 2 ATA.
- Conditions
- Aging
- Being tested
- Hyperbaric Oxygen Therapy
- Keywords
- aging, HBOT, reverse, angiogenesis, elderly, mitochohndria
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hyperbaric Oxygen TherapyDevice
Also called HBOT
60 daily sessions, 90 minutes of 100% oxygen at pressure of 2 ATA each, five days a week for 3 months.
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Experimental | Hyperbaric Oxygen Therapy: 3 months of treatment consisting of 60 daily sessions, 90 minutes of 100% oxygen at pressure of 2 ATA each, five days a week Receives: Device: Hyperbaric Oxygen Therapy |
| Control/Crossover | Other | Hyperbaric Oxygen Therapy: 3 months control period (no treatment) followed by 3 months of treatment consisting of 60 daily sessions, 90 minutes of 100% oxygen at pressure of 2 ATA each, five days a week Receives: Device: Hyperbaric Oxygen Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline of Angiogenesis in brain MRI at 3 and 6 months
imaging will be performed for evaluation of brain changes and angiogenesis processs using MRI perfusion (DSC)
Measured: at baseline, 3 and 6 months
Change from baseline of general cognitive functions index at 3 and 6 months
Patients' cognitive functions will be assessed by Neurotrax computerized cognitive tests to generate the general cognitive index
Measured: at baseline, 3 and 6 months
Change from baseline of exercise VO2 MAX at 3 and 6 months
Using a standard exercise test which includes gas analysis, the change in VO2 maxs will be assessed 3 and 6 months compared to baseline
Measured: at baseline, 3 and 6 months
Secondary outcomes (5)
Change in number of circulating stem cells (CD34) at 3 and 6 months
Blood samples will be drawn for measurements of CD34 stem cells number analyzed by FACS.
Measured: at baseline, 3 and 6 months
Change from baseline of proteinuria at 3 and 6 months
24-hours urine will be collected from all patients for evaluation of proteinuria
Measured: at baseline, 3 and 6 months
Change from baseline of Methacetin breath test at 3 and 6 months
All patients will undergo Methacetin breath test. Voltile CO2 levels will be compared to evaluate changes in liver function.
Measured: at baseline, 3 and 6 months
Change from baseline in bone density at 3 and 6 months
All patients will undergo Dual-energy X-ray absorptiometry to evaluate the change bone density changes
Measured: at baseline, 3 and 6 months
Change from baseline in quality of life measured by SF-36 form at 3 and 6 months
All patients will fill SF-36 questionnaire to evaluate the change in quality of life
Measured: at baseline, 3 and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2016 (estimated)
- Study startDec 2016
- Primary completionJan 2020
- Study completionJan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AgingStudies 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
- Masking
- None (open label)
- Enrolment
- 62 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assaf-Harofeh Medical Center
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Shay Efrati, Assaf-Harofeh Medical Center
- Investigators
- Shai a Efrati, MD, Principal investigator, Asaf-Harofhe MC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02790541
- Sponsor's protocol ID
- 0172-15-ASF
- Acronym
- ANGIOHBOT
- Status last verified
- Apr 2026
- First submitted
- 3 May 2016
- Last updated
- 22 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Hadanny A, Sasson E, Copel L, Daniel-Kotovsky M, Yaakobi E, Lang E, Fishlev G, Polak N, Friedman M, Doenyas K, Finci S, Zemel Y, Bechor Y, Efrati S. Physical enhancement of older adults using hyperbaric oxygen: a randomized controlled trial. BMC Geriatr. 2024 Jul 3;24(1):572. doi: 10.1186/s12877-024-05146-3.
PubMed 38961397
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Changes in Blood Flow and Angiogenesis Induced in the Elderly by Hyperbaric Oxygen Therapy
- ClinicalTrials.gov ID
- NCT02790541
- Acronym / sponsor ID
- ANGIOHBOT / 0172-15-ASF
- Conditions
- Aging
- Keywords
- aging, HBOT, reverse, angiogenesis, elderly, mitochohndria
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 62 participants (actual)
- Lead sponsor
- Assaf-Harofeh Medical CenterOther government
- Study start
- Dec 2016
- Primary completion
- Jan 2020 (actual)
- Study completion
- Jan 2020 (actual)
- First posted
- 6 Jun 2016 (estimated)
- 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.
Recent studies show preliminary evidence of HBOT therapeutic effects on angiogenesis, increased tissue blood flow and oxygenation correlated with tissue function.
Our primary hypothesis is that HBOT will have beneficial effects on the above mentioned organs associated with aging-related malfunctions due to restored mitochondrial function, mobilization of stem cells and induction of angiogenesis.
Detailed description
The paradigm The accumulation of damage to molecules, cells and tissues over a lifetime that contributes to aging eventually leads to frailty and malfunction. The past decade has seen fundamental advances in our understanding of the aging process and raised optimism that interventions to slow ageing may be on the horizon. The aging process is linked to energy deficit due to tissue hypoxia and mitochondria dysfunction.
- Mitochondria dysfunction- Mitochondria are the primary generator of energy by means of ATP synthesis and their dysfunction leads to cellular function decline and degenerative changes. In addition, mitochondria dysfunction in stem cells decreases the capabilities for tissue regeneration.
- Tissue hypoxia- Atherosclerosis is a chronic inflammatory response that damages arterial blood vessels. It begins in childhood and progresses throughout life. A vicious cycle occurs as mitochondrial dysfunction accelerates atherosclerosis and the waning of microvasculature, resulting in decrease blood supply and ensuing relative tissue hypoxia. The decrease oxygen supply to the mitochondria further exacerbates mitochondrial dysfunction.
Hyperbaric oxygen can increase the partial pressure of dissolved (non-hemoglobin-bound) oxygen 20-30 fold and produce two main effects. First, it can eliminate the relative tissue hypoxia induced by atherosclerosis. Second, because mitochondria function is directly influenced by the partial pressure of dissolved oxygen, hyperbaric oxygen can amend mitochondrial dysfunction. Thus, the investigators suggest hyperbaric oxygen as a novel method for breaking the vicious cycle of degeneration and perhaps even for reversing the aging process.
The study is designed as a prospective crossover study aiming to evaluate the therapeutic effects of HBOT on the Brain, Cardiovascular and Immune system, Skin, Erectile (sexual functions), liver and Kidneys, of aging population.
After signing an informed consent form, patients will be invited for baseline evaluations. All patients would be evaluated 3 times - at baseline, after 3 months of follow up, and after additional 3 months of HBOT protocol. The evaluation will include cognitive assessment, questionnaires, MRI scans, blood tests and skin photograph and biopsy. In addition, blood tests will be drawn before and after the 20th, 40th and the 60th sessions for stem cells and mitochondria tests.
Patients will receive 60 daily sessions, 5 days/week, 90 minutes each with 5 minutes air break every 30 minutes, 100% oxygen at 2 ATA.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment | Experimental | Device: Hyperbaric Oxygen TherapyHyperbaric Oxygen Therapy: 3 months of treatment consisting of 60 daily sessions, 90 minutes of 100% oxygen at pressure of 2 ATA each, five days a week |
| Control/Crossover | Other | Device: Hyperbaric Oxygen TherapyHyperbaric Oxygen Therapy: 3 months control period (no treatment) followed by 3 months of treatment consisting of 60 daily sessions, 90 minutes of 100% oxygen at pressure of 2 ATA each, five days a week |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (3 listed)
- Age≥ 65 years
- Capability to sign informed consent.
- No cardiac or cerebrovascular ischemia previous events one year prior to inclusion.
Key exclusion criteria (10 listed)
- Previous treatment with HBOT for any other reason during the last 3 months prior to inclusion.
- Any history of malignancy during the last year prior to inclusion.
- Severe cognitive decline (MMSA<17)
- Severe chronic renal failure (GFR <30)
- Uncontrolled diabetes mellitus (HbA1C>8, fasting glucose>200)
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 TherapyAlso: HBOT60 daily sessions, 90 minutes of 100% oxygen at pressure of 2 ATA each, five days a week for 3 months. | Device | Control/Crossover, Treatment |
Primary outcome
Change from baseline of Angiogenesis in brain MRI at 3 and 6 months
Time frame: at baseline, 3 and 6 months
imaging will be performed for evaluation of brain changes and angiogenesis processs using MRI perfusion (DSC)
Change from baseline of general cognitive functions index at 3 and 6 months
Time frame: at baseline, 3 and 6 months
Patients' cognitive functions will be assessed by Neurotrax computerized cognitive tests to generate the general cognitive index
Change from baseline of exercise VO2 MAX at 3 and 6 months
Time frame: at baseline, 3 and 6 months
Using a standard exercise test which includes gas analysis, the change in VO2 maxs will be assessed 3 and 6 months compared to baseline
5 secondary outcomes
Change in number of circulating stem cells (CD34) at 3 and 6 months
Time frame: at baseline, 3 and 6 months
Change from baseline of proteinuria at 3 and 6 months
Time frame: at baseline, 3 and 6 months
Change from baseline of Methacetin breath test at 3 and 6 months
Time frame: at baseline, 3 and 6 months
Change from baseline in bone density at 3 and 6 months
Time frame: at baseline, 3 and 6 months
Change from baseline in quality of life measured by SF-36 form at 3 and 6 months
Time frame: at baseline, 3 and 6 months
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 22 Apr 2026.
- Derived from this study: PubMed 38961397Hadanny A, Sasson E, Copel L, Daniel-Kotovsky M, Yaakobi E, Lang E, Fishlev G, Polak N, Friedman M, Doenyas K, Finci S, Zemel Y, Bechor Y, Efrati S. Physical enhancement of older adults using hyperbaric oxygen: a randomized controlled trial. BMC Geriatr. 2024 Jul 3;24(1):572. doi: 10.1186/s12877-024-05146-3.
- 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 Therapy in people with Aging, 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 3 inclusion and 10 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 22 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 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?
Change from baseline of Angiogenesis in brain MRI at 3 and 6 months (time frame: at baseline, 3 and 6 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02790541, which also lists 1 linked publication.
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 22 Apr 2026.