HydrocephalusNCT07003152
Relationship Between Hydrocephalus and Endolymphatic Hydrops
An observational study of Hydrocephalus, run by Sohag University.
Trial summary
The goal of this observational study is to assess the prevalence of endolymphatic hydrops in patients with hydrocephalus and assess the auditory functions in patients with hydrocephalus including male and female with 20-60 year age groups. Read more about this study
- Who is it for?
- Ages 20 to 60 years
- Conditions the study is for
- Hydrocephalus
- What is being tested?
- diagnosis of endolymphatic hydrops in hydrocephalus patients
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- 1 Jul 2025to 1 Feb 2026
- How long will I take part?
- 3 Months
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 20 to 60 years
- All sexes
- No healthy volunteers
- Adult
Study population: hydrocephalic patients
Who may be able to join
None listed.
Who cannot join
- History of ear diseases
- History of DM or Hypertension
- History of Ototoxic drug intake.
- Congenital anomalies of the auricle or external auditory meatus.
- History of hereditary hearing loss in the family
- History of noise exposure
- Other neurological problems apart from hydrocephalus
- -
About this study
Official title: Prevalence of Endolymphatic Hydrops Among Patients With Hydrocephalus
The goal of this observational study is to assess the prevalence of endolymphatic hydrops in patients with hydrocephalus and assess the auditory functions in patients with hydrocephalus including male and female with 20-60 year age groups. it aims to assess the prevalence of endolymphatic hydrops in patients with hydrocephalus and to assess the auditory functions in patients with hydrocephalus
- Conditions
- Hydrocephalus
- Being tested
- diagnosis of endolymphatic hydrops in hydrocephalus patients
- Keywords
- Hydrocephalus, endolymphatic hydrops
- Medical subject headings
- Hydrocephalus, Endolymphatic Hydrops
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
diagnosis of endolymphatic hydrops in hydrocephalus patientsDiagnostic test
the hydrocephalus could be associated with endolymphatic hydrops, this study designed to show the relationship between both of these diseases by special tests for diagnosis
| Study group | Role | What they receive |
|---|---|---|
| Adult patients with hydrocephalus ages range from 20-60 years including male and female patients | male and female adult patients with hydrocephalus and exclusion criteria were: History of ear diseases, history of Diabetes mellites, or Hypertension, history of Ototoxic drug intake, Congenital anomalies of the auricle or external auditory meatus, history of hereditary hearing loss in the family, noise exposure, other neurological problems apart from hydrocephalus Receives: Diagnostic Test: diagnosis of endolymphatic hydrops in hydrocephalus patients |
What is being measured
The primary outcome is the main question the study is designed to answer.
hearing assessment
pure-tone audiometry (air conduction and bone conduction) will be done in a clinical soud-isolatedaudiometry room using two-channel diagnostic audiometer model otopront (90 D-65329 Hohenstein, Germany)
Measured: 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2025
- Study start1 Jul 2025 (estimated)
- Primary completion1 Nov 2025 (estimated)
- Study completion1 Feb 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HydrocephalusStudies of the same condition, open and under way.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 20 participants (estimated)
- Target duration
- 3 Months
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Abdelrahman Abdelghafar, Sohag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07003152
- Sponsor's protocol ID
- Soh-Med-25-5-5MS
- Status last verified
- Jun 2025
- First submitted
- 25 May 2025
- Last updated
- 4 Jun 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevalence of Endolymphatic Hydrops Among Patients With Hydrocephalus
- ClinicalTrials.gov ID
- NCT07003152
- Acronym / sponsor ID
- Soh-Med-25-5-5MS
- Conditions
- Hydrocephalus
- Keywords
- Hydrocephalus, endolymphatic hydrops
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- 1 Jul 2025 (estimated)
- Primary completion
- 1 Nov 2025 (estimated)
- Study completion
- 1 Feb 2026 (estimated)
- First posted
- 4 Jun 2025 (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.
The goal of this observational study is to assess the prevalence of endolymphatic hydrops in patients with hydrocephalus and assess the auditory functions in patients with hydrocephalus including male and female with 20-60 year age groups. it aims to assess the prevalence of endolymphatic hydrops in patients with hydrocephalus and to assess the auditory functions in patients with hydrocephalus
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 3 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Adult patients with hydrocephalus ages range from 20-60 years including male and female patients | – | Diagnostic Test: diagnosis of endolymphatic hydrops in hydrocephalus patientsmale and female adult patients with hydrocephalus and exclusion criteria were: History of ear diseases, history of Diabetes mellites, or Hypertension, history of Ototoxic drug intake, Congenital anomalies of the auricle or external auditory meatus, history of hereditary hearing loss in the family, noise exposure, other neurological problems apart from hydrocephalus |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- hydrocephalic patients
Key inclusion criteria (0 listed)
Key exclusion criteria (8 listed)
- History of ear diseases
- History of DM or Hypertension
- History of Ototoxic drug intake.
- Congenital anomalies of the auricle or external auditory meatus.
- History of hereditary hearing loss in the family
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| diagnosis of endolymphatic hydrops in hydrocephalus patientsthe hydrocephalus could be associated with endolymphatic hydrops, this study designed to show the relationship between both of these diseases by special tests for diagnosis | Diagnostic test | Adult patients with hydrocephalus ages range from 20-60 years including male and female patients |
Primary outcome
hearing assessment
Time frame: 16 weeks
pure-tone audiometry (air conduction and bone conduction) will be done in a clinical soud-isolatedaudiometry room using two-channel diagnostic audiometer model otopront (90 D-65329 Hohenstein, Germany)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2025.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Hydrocephalus, run by Sohag University.
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 0 inclusion and 8 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: opening soon, as of the sponsor's last update on 4 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
hearing assessment (time frame: 16 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 4 Jun 2025.