Vertigo LabyrinthineNCT04791930
Evaluation of Vestibular Function in Patients With C.S.O.M: Safe Type
An observational study of Vertigo Labyrinthine, run by Assiut University at 1 site in Egypt.
Trial summary
To evaluate the function of vestibular system in patients with chronic suppurative otitis media safe type. Read more about this study
- Who is it for?
- Ages 10 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Vertigo Labyrinthine
- How many people
- 50 participants
- Where
- 1 siteEgypt
- Study dates
- 28 Oct 2021to Oct 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 to 45 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Study population: patients with chronic suppurative otitis media safe type.
Who may be able to join
- Age: from 10 years to 45 years old.
- Sex: male or female.
- Safe type Chronic Suppurative Otitis Media.
Who cannot join
- Un safe type Chronic Suppurative Otitis Media.
- Noise exposure and heredofamilial hearing loss.
- Adhesive process or history of ear surgery.
Trial locations and contacts
1 site in 1 country.
Mohamed Mohamed Elmoursy, Lecturer contact
Egypt1 site, 1 recruiting
- Recruiting
Assuit University
Asyut
Mohamed Ahmed Abd Elhameed Ali, 01065276753
About this study
Official title: Evaluation of Vestibular Function in Patients With Chronic Suppurative Otitis Media: Safe Type
To evaluate the function of vestibular system in patients with chronic suppurative otitis media safe type.
Read the detailed description
Chronic suppurative otitis media (CSOM) remains one of the most common chronic infectious diseases worldwide, affecting diverse racial and cultural groups both in developing and industrialized countries. It involves considerable morbidity and can cause extra- and intracranial complications .
CSOM in all its clinical presentations (acute, serous and chronic) develops with varying degrees of lesions in the inner ear, which showing a higher prevalence of disabling hearing loss, tinnitus and balance and vestibular alterations.
In recent years, authors have raised the hypothesis that the vestibular system could also be subject to inflammatory lesions secondary to CSOM. These hypotheses were supported by clinical studies, which disclosed a high prevalence of vestibular symptoms in patients with CSOM (40% -60%), in addition to changes in several vestibular function tests (caloric testing, rotary chair, vestibular evoked myogenic potentials, vHIT and posturography) .
Over the years, several studies have analyzed the potential clinical impact of CSOM on vestibular function (Monsanto et al, 2018). However, a recent systematic review showed that these studies are mostly have had several biases identified (selection, attrition, performance and detection) .
Also, there are a number of difficulties regarding changes in vestibular function secondary to CSOM, mainly because several vestibular function tests (caloric testing, vestibular evoked myogenic potentials) do not have validated results for patients with middle ear disorders inherent to CSOM (tympanic perforation, ossicular erosion, fibrosis or secretion in the middle ear, and conductive hearing loss), and therefore are not directly comparable to those of patients without middle ear diseases.
Furthermore, CSOM is more prevalent in the elderly, who have several other possible causal factors for vestibular symptoms, therefore, directly correlating CSOM with changes in vestibular function is a challenging task .
One of the vestibular function tests of that is not significantly influenced by CSOM is the video head impulse test, this test can objectively assess the function of each one of the semicircular canals alone, providing important information regarding changes in the vestibulo-ocular reflex (VOR), despite these advantages, the literature on the use of the video head impulse test in patients with COM is very scarce. Considering the role of the head impulse test in the diagnosis of VOR alterations, the identification of alterations in this test can help in the topographic characterization of vestibular alterations secondary to COM .
Evaluation of vestibular function in patients with safe type chronic suppurative otitis media provide many strategies aimed to prevent the sequelae and give idea about selection of adequate treatment and rehabilitation .
- Conditions
- Vertigo Labyrinthine
- Keywords
- Chronic suppurative otitis media, safe type, vertigo, vestibular testing, vestibular function, VNG, Rotatory Chair
- Medical subject headings
- Vertigo
What is being measured
The primary outcome is the main question the study is designed to answer.
Vestibular evaluation
The incidence and extent of vestibular dysfunction in patients with chronic suppurative otitis media: safe type
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2021
- Study start28 Oct 2021 (estimated)
- Primary completion28 Apr 2023 (estimated)
- Study completionOct 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Vertigo LabyrinthineStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed Ahmed Abd Elhameed Ali, Assiut University
- Investigators
- Enass sayed Mohamed, Professor, Principal investigator, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04791930
- Sponsor's protocol ID
- VNG&C.S.O.M
- Status last verified
- Mar 2021
- First submitted
- 9 Feb 2021
- Last updated
- 10 Mar 2021
- Results posted
- No
- Individual data sharing
- Yes
Publications
Monsanto RDC, Kasemodel ALP, Tomaz A, Elias TGA, Paparella MM, Penido NO. Evaluation of vestibular symptoms and postural balance control in patients with chronic otitis media. J Vestib Res. 2020;30(1):35-45. doi: 10.3233/VES-200691.
PubMed 32083607
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Vestibular Function in Patients With Chronic Suppurative Otitis Media: Safe Type
- ClinicalTrials.gov ID
- NCT04791930
- Acronym / sponsor ID
- VNG&C.S.O.M
- Conditions
- Vertigo Labyrinthine
- Keywords
- Chronic suppurative otitis media, safe type, vertigo, vestibular testing, vestibular function, VNG, Rotatory Chair
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 28 Oct 2021 (estimated)
- Primary completion
- 28 Apr 2023 (estimated)
- Study completion
- Oct 2023 (estimated)
- First posted
- 10 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To evaluate the function of vestibular system in patients with chronic suppurative otitis media safe type.
Detailed description
Chronic suppurative otitis media (CSOM) remains one of the most common chronic infectious diseases worldwide, affecting diverse racial and cultural groups both in developing and industrialized countries. It involves considerable morbidity and can cause extra- and intracranial complications .
CSOM in all its clinical presentations (acute, serous and chronic) develops with varying degrees of lesions in the inner ear, which showing a higher prevalence of disabling hearing loss, tinnitus and balance and vestibular alterations.
In recent years, authors have raised the hypothesis that the vestibular system could also be subject to inflammatory lesions secondary to CSOM. These hypotheses were supported by clinical studies, which disclosed a high prevalence of vestibular symptoms in patients with CSOM (40% -60%), in addition to changes in several vestibular function tests (caloric testing, rotary chair, vestibular evoked myogenic potentials, vHIT and posturography) .
Over the years, several studies have analyzed the potential clinical impact of CSOM on vestibular function (Monsanto et al, 2018). However, a recent systematic review showed that these studies are mostly have had several biases identified (selection, attrition, performance and detection) .
Also, there are a number of difficulties regarding changes in vestibular function secondary to CSOM, mainly because several vestibular function tests (caloric testing, vestibular evoked myogenic potentials) do not have validated results for patients with middle ear disorders inherent to CSOM (tympanic perforation, ossicular erosion, fibrosis or secretion in the middle ear, and conductive hearing loss), and therefore are not directly comparable to those of patients without middle ear diseases.
Furthermore, CSOM is more prevalent in the elderly, who have several other possible causal factors for vestibular symptoms, therefore, directly correlating CSOM with changes in vestibular function is a challenging task .
One of the vestibular function tests of that is not significantly influenced by CSOM is the video head impulse test, this test can objectively assess the function of each one of the semicircular canals alone, providing important information regarding changes in the vestibulo-ocular reflex (VOR), despite these advantages, the literature on the use of the video head impulse test in patients with COM is very scarce. Considering the role of the head impulse test in the diagnosis of VOR alterations, the identification of alterations in this test can help in the topographic characterization of vestibular alterations secondary to COM .
Evaluation of vestibular function in patients with safe type chronic suppurative otitis media provide many strategies aimed to prevent the sequelae and give idea about selection of adequate treatment and rehabilitation .
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
Who may qualify
- Ages
- 10 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- patients with chronic suppurative otitis media safe type.
Key inclusion criteria (3 listed)
- Age: from 10 years to 45 years old.
- Sex: male or female.
- Safe type Chronic Suppurative Otitis Media.
Key exclusion criteria (3 listed)
- Un safe type Chronic Suppurative Otitis Media.
- Noise exposure and heredofamilial hearing loss.
- Adhesive process or history of ear surgery.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Vestibular evaluation
Time frame: Baseline
The incidence and extent of vestibular dysfunction in patients with chronic suppurative otitis media: safe type
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 2021.
- Background: PubMed 32083607Monsanto RDC, Kasemodel ALP, Tomaz A, Elias TGA, Paparella MM, Penido NO. Evaluation of vestibular symptoms and postural balance control in patients with chronic otitis media. J Vestib Res. 2020;30(1):35-45. doi: 10.3233/VES-200691.
- Individual participant dataSharing planned: Yes
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mohamed Mohamed Elmoursy, Lecturer contact
Enass sayed Mohamed, Professor principal investigator
Assiut University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Vertigo Labyrinthine, run by Assiut University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 10 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mohamed Ahmed Abd Elhameed Ali (01065276753, dr.mohamed.ammar93@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Vestibular evaluation (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04791930, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Mar 2021.