Etiological Study of Persistent Velopharyngeal Insufficiency in Children With Operated Velopalatine Cleft by Analysis of Velopharyngeal Motor Skills in Static and Dynamic MRI

NCT06072495 · tracked via the Priya Life Science France tracker

Sponsor

Centre Hospitalier Universitaire, Amiens

Phase

Not applicable

Started

2024-11-06

Last updated

2026-06-15

Condition(s) studied

Velopharyngeal InsufficiencyReal Time MRICleft Palate

Investigational drug(s) / intervention(s)

real time MRI

real time MRI: ubjects will be scanned in the supine position using ACHIEVA 3T TX DStream Philips® and a 33 channels head and neck coil. An elastic strap will be fixed to the forehead to limits movement during scan. Headset will be used to cancel the loud MRI noise and to communicate with the subjects

Study summary

Velopharyngeal insufficiency is defined as the inability of the soft palate to isolate the nasopharynx from the oropharynx. It is a frequent sequela in patients with a velopalatine cleft despite anatomical restoration of the soft palate by intravelar veloplasty at 6 months. If rehabilitation by a speech therapist is not successful, a pharyngoplasty can be discussed. In the last ten years, MRI was used in dynamic and static way, to analyzed velopharyngeal muscles, in particular Levator Veli Palatini. MRI could be used to identify the etiology of VPI in those patients, and thus allow personalized rehabilitation and surgical management. The aim of this study is to examine the differences in velopharyngeal motricity as well as velar muscles morphology, positioning, and symmetry of children with repaired cleft palate with different degrees of severity of velopharyngeal insufficiency (VPI), and children with labial cleft (noncleft palate anatomy).

Eligibility

Sex

ALL

Min age

7 Years

Max age

12 Years

Healthy volunteers

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.

Primary outcome measure(s)

ratio between the diameter of pharynx at rest and during phonation. — day 1
closure distance between the velar knee and the posterior pharyngeal wall — day 1
distance between the velar knee and the posterior pharyngeal wall — day 1

Trial sites (1)

Facility	City	Region	Status
CHU Amiens-Picardie	Amiens	France	Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06072495 on ClinicalTrials.gov ↗ ← All trials in France