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French kids help set new standard for diagnosing speech disorders

NCT ID NCT04934306

Knowledge-focused Sponsor: Assistance Publique - Hôpitaux de Paris Source: ClinicalTrials.gov ↗

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study measured normal nasalance scores in 131 French-speaking children aged 8 to 10 using a non-invasive device called a Nasometer. The goal is to create reference values that help doctors diagnose velopharyngeal dysfunction, a common issue in children with cleft palate, without needing invasive procedures like nasofibroscopy. The results will improve how speech problems are detected and managed.

What this could mean

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

What this could lead to
If successful, this study will provide normal reference values for nasalance, improving diagnosis of velopharyngeal dysfunction in children without invasive procedures.
What could go wrong
This is an observational study, not a treatment trial. It only establishes norms and does not test any therapy or intervention.

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

131 people

The number who actually took part.

Started

Sep 2021

Finished

Jan 2024

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

Patients followed by the Pediatric ENT department of Necker-Enfants Malades hospital

Ages

8 to 10 years

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: * Holders of parental authority and patients informed and not opposing their participation in the study * Patients aged 8 to 10 years old * native-French speakers (French from France including the French overseas departments and territories) * Educated in France in an ordinary environment * Patients without a cleft * Patients with a cleft : patients with a hard and/or soft palate cleft and for whom the perceptual speech-language pathology evaluation revealed a velopharyngeal insufficiency Exclusion Criteria: Patients without developmental speech disorder (including articulation disorder) or hearing impairment

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Conditions

The condition(s) this trial relates to.

cleft palate

As listed by the trial registrant

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

Resonance disorder

Contacts and locations

Locations

  • Hôpital Necker-Enfants Malades

    Paris, 75015, France

More trials for these conditions

Other studies related to the condition(s) this trial covers.