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

The purpose of this study is to examine changes in cardiac autonomic nerve system function in patients receiving Hyperbaric oxygen therapy .

Study Overview

• Status: Terminated
• Conditions: Neurological Injury

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.

• Study Type: Observational
• Enrollment (Actual): 17

Contacts and Locations

Study Locations

• Israel
  • Rishon LeZiyyon, Israel
    • hyperbaric center Asaf harofe medical center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients who are scheduled to receive a series of treatments at a pressure cell at Assaf Harofeh Hospital

Description

Inclusion Criteria:

Patients who are scheduled to receive a series of treatments at a pressure cell at Assaf Harofeh Hospital and are willing to participate in the study.

Exclusion Criteria:

• Patients who received previous hyperbaric oxygen therapy for any reason during the 6 months prior to inclusion.
• A history of malignancy during the last year of inclusion.
• A pulmonary disease that does not allow the patient to be admitted to a pressure cell (severe emphysema, moderate obstruction) .
• patients that unable to sign informed consent form.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Heart Rate Variability- Time messurment	the square Root of the Mean Square successive RR differences(RMSSD) , Mean RR- Mean of R-R intervals.	3 month

Collaborators and Investigators

• Sponsor: Assaf-Harofeh Medical Center
• Collaborators: Ariel University
• Investigators: Principal Investigator: Shay Efrati, Prof, Asaf-Harofhe MC

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2018
• Primary Completion (Actual): July 1, 2020
• Study Completion (Actual): July 1, 2020

Study Registration Dates

• First Submitted: July 2, 2019
• First Submitted That Met QC Criteria: April 16, 2026
• First Posted (Actual): April 17, 2026

Study Record Updates

• Last Update Posted (Actual): April 17, 2026
• Last Update Submitted That Met QC Criteria: April 16, 2026
• Last Verified: June 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Wounds and Injuries; Trauma, Nervous System
• Other Study ID Numbers: 0305-17

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No