Effects of Hyperbaric Oxygen Therapy on Middle and Inner Ear Functions (HBOT)

January 13, 2024 updated by: Nahla Ahmed Abd elhafez Mousa, Assiut University

The goal of this observational study is to measure the effect of hyperbaric oxygen therapy on middle ear pressure in order to predict the risk factors for middle ear barotrauma also, to assess its effects on hearing functions of the inner ear in participant population. The main questions aim to answer are:

  • Is there a change in middle ear pressure before and after exposure to hyperbaric oxygen therapy ?
  • Is there a change in hearing threshold level before and after exposure to hyperbaric oxygen therapy ? The middle ear pressure, eustachian tube functions and the hearing threshold of the participants will be assessed immediately before the fist session and within one hour after the first and tenth sessions.

Study Overview

Status

Not yet recruiting

Conditions

Detailed Description

Fifty four patients already treated by hyperbaric oxygen therapy recruited from hyperbaric oxygen therapy center of Assiut university hospitals. Otoscopic examination for all patients must be done before and after the session , assessment of middle ear pressure and the state of the eustachian tube through doing eustachian tube function tests (Valsalva and Toynbee tests for ears with intact tympanic membrane and modified inflation - deflation tests for ears with perforated tympanic membrane) by tympanometry for all patients before and after the first session of hjyperbaric oxygen therapy and after completion of the tenth session. Assessment of the hearing threshold level of the patients immediately before the first session and after the tenth session of hyperbaric oxygen therapy through doing pure tone audiometry ( air conduction and bone conduction audiometry) and speech audiometry to assess the speech discrimination score for the patients

Study Type

Observational

Enrollment (Estimated)

54

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Probability Sample

Study Population

Patients of both sexes already recommended to be treated by hyperbaric oxygen therapy for various medical conditions in hyperbaric oxygen therapy center.

Description

Inclusion Criteria:

  • Patients of at least 18 years old.
  • Patients accept participation in the research.
  • Patients with out history of middle ear diseases.

Exclusion Criteria:

  • Patients under age of 18 years old.
  • Patients have middle ear effusion.
  • Patients refuse to participate in the research.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Measuring the changes of the middle ear pressure after exposure to hyperbaric oxygen therapy
Time Frame: Immediately before exposure to the first session of hyperbaric oxygen therapy and within one hour after exposure to the first and tenth session of hyperbaric oxygen therapy.
Tympanometric assessment of the middle ear pressure and eustachian tube functions
Immediately before exposure to the first session of hyperbaric oxygen therapy and within one hour after exposure to the first and tenth session of hyperbaric oxygen therapy.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assiut University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

January 1, 2024

Primary Completion (Estimated)

May 1, 2024

Study Completion (Estimated)

May 1, 2024

Study Registration Dates

First Submitted

January 4, 2024

First Submitted That Met QC Criteria

January 13, 2024

First Posted (Estimated)

January 17, 2024

Study Record Updates

Last Update Posted (Estimated)

January 17, 2024

Last Update Submitted That Met QC Criteria

January 13, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Audiology2024

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Middle Ear Barotrauma

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Congo

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe