Inner and Middle Ear Effects of Hyperbaric Oxygen Thrapy

Otitic Barotrauma Clinical Trial

Official title:

Inner and Middle Ear Effects of Hyperbaric Oxygen Therapy

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04186741
• Other study ID #: IMO
• Status: Not yet recruiting
• Start date: April 2021
• Est. completion date: June 2022

Study information

• Verified date: December 2019
• Source: Assiut University
• Contact: Nahla A Mousa
• Phone: 01142338708
• Email: totydodeg[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 30
• Est. completion date: June 2022
• Est. primary completion date: October 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 10 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Barotrauma
• Otitic Barotrauma

Intervention

Drug:
• Hyperbaric oxygen
Patients already on treatment by hyperbaric oxygen therapy for medical conditions requiring treatment by it

Locations

Country	Name	City	State
Egypt	Assiut university	Assiut

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

Country where clinical trial is conducted

Egypt, 

References & Publications (1)

Yamamoto Y, Noguchi Y, Enomoto M, Yagishita K, Kitamura K. Otological complications associated with hyperbaric oxygen therapy. Eur Arch Otorhinolaryngol. 2016 Sep;273(9):2487-93. doi: 10.1007/s00405-015-3845-9. Epub 2015 Dec 9. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changing in middle ear pressure	Measuring middle ear pressure before exposure ro hyperbaric oxygen and following each of the first five treatments	Through completion of study after 2 years