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

Status

Terminated

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT07537452

Enrollment

Registered

2026-04-17

Start date

2018-08-01

Completion date

2020-07-01

Last updated

2026-04-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Neurological Injury

Brief 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.

Interventions

None listed

Study design

Observational model

CASE_ONLY

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

Healthy volunteers

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.

Design outcomes

Primary

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

Countries

Israel

Contacts

PRINCIPAL_INVESTIGATORShay Efrati, Prof

Asaf-Harofhe MC

Outcome results