Inner and Middle Ear Effects of Hyperbaric Oxygen Thrapy

July 7, 2020 updated by: Nahla Ahmed Abd elhafez Mousa, Assiut University

Inner and Middle Ear Effects of Hyperbaric Oxygen Therapy

Audiological evaluation performed to patients on hyperbaric oxygen therapy to see its effects on middle ear pressure

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Thirty patients will be recruited from center pf hyperbaric oxygen therapy Every patient who received HBOT was submitted for Demographic data:age,gender,condition raquiring HBOT,use of analgesics,history of diabets ,cardiovascular or respiratory disease ,psychatric illness,smoking history facial/ENT problems and previous HBOT problems then tympanometry and basic pure tone audiometry including air and bone conduction is done following each of the first five treatment

Study Type

Observational

Enrollment (Anticipated)

30

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Assiut, Egypt
        • Assiut University

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

10 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Measument of middle ear pressure after exposure to hyper baric oxygen therapy

Description

Inclusion Criteria:

  • patients above 18 years old already recieving hyperbaric oxygen therapy for treatment of other medical conditions required treatment by it as in diabetic foot

Exclusion Criteria:

  • patients who already had tympanostomy tubes

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

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
HBO Group
Patients already recieving hyperbaric oxygen therapy for treatment of other medical conditions requiring it as in diabetic foot , cerebral infarctions
Drug: Hyperbaric oxygen
Patients already on treatment by hyperbaric oxygen therapy for medical conditions requiring treatment by it

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changing in middle ear pressure
Time Frame: Through completion of study after 2 years
Measuring middle ear pressure before exposure ro hyperbaric oxygen and following each of the first five treatments
Through completion of study after 2 years

Collaborators and Investigators

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

Sponsor

Assiut University

Investigators

  • Principal Investigator: Enas S Mohamed, Professor, Assiut University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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 (Anticipated)

April 1, 2021

Primary Completion (Anticipated)

October 1, 2021

Study Completion (Anticipated)

June 1, 2022

Study Registration Dates

First Submitted

November 15, 2019

First Submitted That Met QC Criteria

December 2, 2019

First Posted (Actual)

December 5, 2019

Study Record Updates

Last Update Posted (Actual)

July 9, 2020

Last Update Submitted That Met QC Criteria

July 7, 2020

Last Verified

December 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IMO

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.

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