NCT07537452

Response of the Cardiac Autonomic Control System After Oxygen Therapy 100% in Hyperbaric Environment

• Status: Terminated
• Phase: —
• Study type: Observational
• Enrollment: 17 (actual)
• Sponsor: Assaf-Harofeh Medical Center · Other Government
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Neurological Injury

Timeline

• Start date: 2018-08-01
• Primary completion: 2020-07-01
• Completion: 2020-07-01
• First posted: 2026-04-17
• Last updated: 2026-04-17

Locations

1 site across 1 country: Israel