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MRI scans reveal hidden causes of speech issues in cleft palate kids

NCT ID NCT06072495

Knowledge-focused Sponsor: Centre Hospitalier Universitaire, Amiens Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 investigates why some children still have speech problems (velopharyngeal insufficiency) after cleft palate surgery. Researchers will use real-time MRI to look at how the soft palate moves and its muscle structure in children aged 7 to 12. By comparing children with different levels of speech difficulty, they hope to find clues that could lead to more personalized treatments.

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 could help doctors personalize rehabilitation or surgery for children with persistent speech problems after cleft palate repair.
What could go wrong
This is a small observational study, so it may not lead to immediate changes in treatment. The findings might not apply to all children with cleft palate.

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.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 30 people

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

Started

Nov 2024

Expected to finish

Jun 2026

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.

Ages

7 to 12 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: * Children aged 7 to 12 years with Isolated cleft lip * isolated velopalatal cleft * Without a diagnosis of syndromic cleft or Pierre Robin sequence * French speaking, and French is the native language * Operated with a cheiloplasty (for cleft lip) or an intravelar Veloplasty (according to Sommerlad) at the Amiens University Hospital * Whose follow-up is done at the Amiens University Hospital Exclusion Criteria: * Refusal of the parents and/or the patient * With a contraindication to MRI * Whose follow-up was initiated in another center and/or whose surgery was performed in another center * Whose surgical schedule has not been followed * Patient with severe neurological or neuropsychiatric disorders or Severe speech and language delay not related to the cleft anatomy * Patients treated with fixed, non-removable orthodontic treatment.

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Conditions

The condition(s) this trial relates to.

cleft lip cleft palate congenital velopharyngeal incompetence

As listed by the trial registrant

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

Cleft palate Real time mri Velopharyngeal insufficiency

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

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • CHU Amiens-Picardie

    RECRUITING

    Amiens, 80054, France

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