Effects of Hyperbaric Oxygen Therapy on Middle and Inner Ear Functions

NCT06209021 | Unknown

• 1 other identifier: Audiology2024
• Study Type: observational
• Target: 54
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Middle Ear Barotrauma

Outcome Measures

Primary Outcomes (1)

• Measuring the changes of the middle ear pressure after exposure to 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.

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Assiut University: lead

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle investigator

Study Record Dates

• First Submitted: January 4, 2024
• First Posted: January 17, 2024
• Study Start: January 1, 2024
• Primary Completion: May 1, 2024
• Study Completion: May 1, 2024
• Last Updated: January 17, 2024

Record last verified: 2024-01