Normative Nasalance Scores for Native French-speaking Children

Status: Completed
Location: See location...
Intervention Type: Other
Study Type: Observational
SUMMARY

The velopharyngeal mechanisms (in particular the movements of the soft palate) is frequently affected by craniofacial anomalies such as cleft lip and palate. Nasofibroscopy is frequently used in clinical care to assess the velopharyngeal function because it allows for direct visualization of the velopharyngeal port. However, it is an invasive procedure that could not be tolerated well by children. Nasometry is a non-invasive acoustic measurement technique which can be used to objectively assess a velopharyngeal dysfunction (whether it can be heard or not), and thus supplement the perceptual evaluation conducted by a trained clinician. The main objective of this study is to establish normative nasalance scores with the KayPENTAX Nasometer (Nasometer II 6450 model) for native French-speaking children between 8 and 10 years old.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 8
Maximum Age: 10
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
France
Hôpital Necker-Enfants Malades
Paris
Time Frame
Start Date: 2021-09-16
Completion Date: 2024-01-24
Participants
Target number of participants: 131
Treatments
Patients without cleft
Patients without developmental speech disorder (including articulation disorder) or hearing impairment
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
Authors
Héloïse BARBIER
Related Therapeutic Areas
Sponsors
Collaborators: URC-CIC Paris Descartes Necker Cochin
Leads: Assistance Publique - Hôpitaux de Paris

This content was sourced from clinicaltrials.gov