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Can a single gene explain a hidden form of hearing loss?

NCT ID NCT07778641

Knowledge-focused Sponsor: Sohag University Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Aug 21, 2026 · Last updated Aug 21, 2026

Summary

This study investigates how often changes in the OTOF gene are linked to auditory neuropathy spectrum disorder (ANSD), a condition where sound enters the ear but the brain has trouble processing it. Researchers will analyze the DNA of 30 people with non-syndromic ANSD using whole exome sequencing, focusing on the OTOF gene. The goal is to better understand the genetic causes of this hearing disorder, which could improve diagnosis and genetic counseling in the future.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Whole exome sequencing (genetic test analyzing protein-coding regions of the genome, focusing on the OTOF gene)
What this could lead to
If this study succeeds, it could clarify how common OTOF gene changes are in auditory neuropathy, potentially guiding future genetic testing and counseling for affected families.
What could go wrong
This is a small observational study, so findings may not apply to all patients. Also, not all auditory neuropathy cases are caused by OTOF variants, so the study may only capture a subset.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 30 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Aug 2026

An estimate. Start dates often move.

Expected to finish

Feb 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

The study population will consist of patients diagnosed with auditory neuropathy spectrum disorder (ANSD) who meet the predefined eligibility criteria and attend the participating audiology/otolaryngology clinic during the study recruitment period. Eligible participants will undergo genetic analysis to assess for pathogenic or potentially pathogenic variants in the OTOF gene. Participants may include children and adults with ANSD, regardless of sex.

Ages

Children (under 18), adults (18 to 64) and older adults (65 and over)

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. The study will be including 30 subjects of 30 patients of both sexes of any age with congenital hearing loss and confirmed diagnosis of non-syndromic ANSD: A) Disproportionate speech discrimination score (SDS) with the hearing threshold level. B)The auditory brainstem response (ABR) test with no waveform, disturbed waves, nor detectable wave V at high intense stimulus. C) The otoacoustic emission (OAE) and/or cochlear microphonic (CM) potential may be present. 2. Informed consent. Exclusion Criteria: * 1\) Known acquired risk factors of ANSD as preterm, hypoxia, hyperbilirubinemia. 2) Conductive hearing loss. 3) Syndromic ANSD hearing loss. 3) Binaural cochlear implants. 4) Inner ear malformation, cochlear nerve aplasia or hypoplasia.

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Conditions

The condition(s) this trial relates to.

auditory neuropathy Deafness, Autosomal Recessive 9 Hearing Loss, Hidden

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Auditory neuropathy Auditory neuropathy spectrum disorder

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

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Contacts and locations

Locations

  • Faculty of medicine, Sohag University

    Sohag, Sohag Governorate, 82511, Egypt

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