NCT07003152

Brief 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. it aims to assess the prevalence of endolymphatic hydrops in patients with hydrocephalus and to assess the auditory functions in patients with hydrocephalus

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jul 2025

Shorter than P25 for all trials

Status
not yet recruiting

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 25, 2025

Completed
10 days until next milestone

First Posted

Study publicly available on registry

June 4, 2025

Completed
27 days until next milestone

Study Start

First participant enrolled

July 1, 2025

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2025

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2026

Completed
Last Updated

June 4, 2025

Status Verified

June 1, 2025

Enrollment Period

4 months

First QC Date

May 25, 2025

Last Update Submit

June 3, 2025

Conditions

Keywords

Hydrocephalus, endolymphatic hydrops

Outcome Measures

Primary Outcomes (1)

  • 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)

    16 weeks

Study Arms (1)

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

Diagnostic Test: diagnosis of endolymphatic hydrops in hydrocephalus patients

Interventions

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

Adult patients with hydrocephalus ages range from 20-60 years including male and female patients

Eligibility Criteria

Age20 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

hydrocephalic patients

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

HydrocephalusEndolymphatic Hydrops

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System DiseasesLabyrinth DiseasesEar DiseasesOtorhinolaryngologic Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
3 Months
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Resident doctor

Study Record Dates

First Submitted

May 25, 2025

First Posted

June 4, 2025

Study Start

July 1, 2025

Primary Completion

November 1, 2025

Study Completion

February 1, 2026

Last Updated

June 4, 2025

Record last verified: 2025-06