Asaf Harofeh Medical Center
Ẕerifin, 70300, Israel
NCT Number: NCT02790541
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.
Looking for future studies?
Notify Me65 year and older
All sexes
Interventional
Not applicable
Ẕerifin, 70300, Israel
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.
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
60 daily sessions, 90 minutes of 100% oxygen at pressure of 2 ATA each, five days a week for 3 months.
Other names: HBOT
Time frame: at baseline, 3 and 6 months
imaging will be performed for evaluation of brain changes and angiogenesis processs using MRI perfusion (DSC)
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
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
Time frame: at baseline, 3 and 6 months
Blood samples will be drawn for measurements of CD34 stem cells number analyzed by FACS.
Time frame: at baseline, 3 and 6 months
24-hours urine will be collected from all patients for evaluation of proteinuria
Time frame: at baseline, 3 and 6 months
All patients will undergo Methacetin breath test. Voltile CO2 levels will be compared to evaluate changes in liver function.
Time frame: at baseline, 3 and 6 months
All patients will undergo Dual-energy X-ray absorptiometry to evaluate the change bone density changes
Time frame: at baseline, 3 and 6 months
All patients will fill SF-36 questionnaire to evaluate the change in quality of life
Assaf-Harofeh Medical Center
Other Gov
Changes in Blood Flow and Angiogenesis Induced in the Elderly by Hyperbaric Oxygen Therapy
Acronym: ANGIOHBOT
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT05017129
Aging
Golden, Colorado, United States
View Trial DetailsNCT03814304
Accidental Falls, Aging
Roslindale, Massachusetts, United States
View Trial DetailsNCT05866393
Aging, Behavior
Cleveland, Ohio, United States
View Trial DetailsNCT04276805
Aging
Tucson, Arizona, United States
View Trial Details