NCT04186741

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Apr 2021

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 15, 2019

Completed
20 days until next milestone

First Posted

Study publicly available on registry

December 5, 2019

Completed
1.3 years until next milestone

Study Start

First participant enrolled

April 1, 2021

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2021

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2022

Completed
Last Updated

July 9, 2020

Status Verified

December 1, 2019

Enrollment Period

6 months

First QC Date

November 15, 2019

Last Update Submit

July 7, 2020

Conditions

Otitic Barotrauma

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (1)

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

Interventions

Hyperbaric oxygenDRUG

Patients already on treatment by hyperbaric oxygen therapy for medical conditions requiring treatment by it

HBO Group

Eligibility Criteria

Age10 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

  • patients who already had tympanostomy tubes

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Assiut university

Asyut, Egypt

Location

Related 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.

    PMID: 26650550RESULT

MeSH Terms

Interventions

Hyperbaric Oxygenation

Intervention Hierarchy (Ancestors)

Oxygen Inhalation TherapyRespiratory TherapyTherapeutics

Study Officials

  • Enas S Mohamed, Professor

    Assiut University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Nahla A Mousa

CONTACT

01142338708totydodeg@gmail.com

Eman A Elgendy, Professor

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principle investigator

Study Record Dates

First Submitted

November 15, 2019

First Posted

December 5, 2019

Study Start

April 1, 2021

Primary Completion

October 1, 2021

Study Completion

June 1, 2022

Last Updated

July 9, 2020

Record last verified: 2019-12

Locations

EG(1)