The use of MRI-scans to assess velopharyngeal insufficiency in cleft palate patients

Conditions: Velopharyngeal insufficiency
hypernasal speech
10028396

Registration Number: NL-OMON56871

Lead Sponsor: Amsterdam UMC

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Pending

Sex: Not specified

Target Recruitment: 30

Inclusion Criteria

- >4 years of age
- History of non-syndromic unilateral cleft lip and palate (UCLP)
- History of cleft palate repair (Von Langenbeck technique)
- No history of secondary palate surgery
- Hypernasality
- Informed consent
- Patient <12 years of age: informed consent required from parent(s)/legal
guardian(s)
- Patients 12-16 years of age: informed consent required from both patient and
parent(s)/legal guardian(s)
- Patient >16 years of age: informed consent required from patient
- Patient can be well instructed with regard to the MRI scan

Exclusion Criteria

- <4 years of age
- Syndromes
- No history of UCLP
- Primary cleft palate repair with other technique than Von Langenbeck
- History of secondary palate surgery
- No hypernasality
- No informed consent
- Non removable orthodontic device
- Patient cannot be well instructed with regard to the MRI scan
- Any exclusion criteria regarding the MRI scan

Study & Design

Study Type: Observational non invasive

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Differences in MRI-measured parameters of velopharyngeal anatomy between<br /><br>patients with cleft palate and VPI, and individuals with cleft palate without<br /><br>VPI. Differences in MRI-measured parameters of velopharyngeal anatomy between<br /><br>patients in which speech therapy/surgical treatment is/is not successful, and<br /><br>individuals with cleft palate without VPI. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary study parameters include the same research questions as described<br /><br>with regard to MRI measured parameters on velopharyngeal anatomy, applied to<br /><br>nasometry, speech test, nasendoscopy, oral inspection and PROMs outcomes. </p><br>