NCT02790541

Angiogenesis Induced in the Elderly by Hyperbaric Oxygen Therapy

Changes in Blood Flow and Angiogenesis Induced in the Elderly by Hyperbaric Oxygen Therapy

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 62 (actual)
• Sponsor: Assaf-Harofeh Medical Center · Other Government
• Sex: All
• Age: 65 Years
• Healthy volunteers: Accepted

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 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.

Conditions

• Aging

Interventions

Type	Name	Description
DEVICE	Hyperbaric Oxygen Therapy	60 daily sessions, 90 minutes of 100% oxygen at pressure of 2 ATA each, five days a week for 3 months.

Timeline

• Start date: 2016-12-01
• Primary completion: 2020-01-01
• Completion: 2020-01-01
• First posted: 2016-06-06
• Last updated: 2020-01-06

Locations

1 site across 1 country: Israel