Nasalance Scores for Normal-speaking French Children

NCT ID: NCT04934306

Last Updated: 2025-09-15

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 131 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-09-16
• Study Completion Date: 2024-01-24

Brief 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.

Detailed Description

The velopharyngeal mechanism (in particular the movements of the soft palate) is frequently affected by craniofacial anomalies such as cleft lip and palate and it needs to be assessed. Indeed, the velopharyngeal sphincter has to be efficient in order to properly isolate the oral cavity from the nasal cavity. Thus, the nasal cavity is protected during swallowing (preventing food or liquids from passing through the nose). It also ensures a correct phonation and articulation of oral phonemes.

A perceptual evaluation of the velopharyngeal function is always conducted by a clinician. But it is a subjective assessment which may need to be supplemented by an objective instrumental assessment. Nasofibroscopy is frequently used in clinical care to evaluate 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 on the other hand is a non-invasive acoustic measurement technique. It is based on the relation between nasal and oral acoustic energy and determines a nasalance score. Calculated in real time during speech production, the nasalance is a measure expressed as a percentage : (nasal acoustic energy) / (sum of oral and nasal acoustic energy). The device computing the nasalance score is called a Nasometer.

Thus, in addition to the speech therapist's perceptual evaluation, nasometry can be used to objectively assess and quantify a velopharyngeal dysfunction whether it can be heard or not. However in order to determine if a patient's nasalance score is pathological or not, it must be compared to standardized norms. Yet presently, there are no normative nasalance data for French-speaking children. 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.

Conditions

Resonance Disorder

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: CROSS_SECTIONAL

Study Groups

Patients without cleft

Patients without developmental speech disorder (including articulation disorder) or hearing impairment

Nasometry

Intervention Type: OTHER

Repetition of several stimuli (syllables, sentences ) in the microphones of the Nasometer

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

Nasometry

Intervention Type: OTHER

Repetition of several stimuli (syllables, sentences ) in the microphones of the Nasometer

Interventions

Nasometry

Repetition of several stimuli (syllables, sentences ) in the microphones of the Nasometer

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 8 Years
• Maximum Eligible Age: 10 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

URC-CIC Paris Descartes Necker Cochin

OTHER

Sponsor Role: collaborator

Assistance Publique - Hôpitaux de Paris

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Natacha KADLUB, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Assistance Publique - Hôpitaux de Paris

Cécile CHAPUIS-VANDENBOGAERDE, MD

Role: STUDY_DIRECTOR

Assistance Publique - Hôpitaux de Paris

Locations

Hôpital Necker-Enfants Malades

Paris, , France

Countries

France

References

Barbier H, Redouloux L, Chapuis-Vandenbogaerde C, Picard A, Amelot A, Fougeron C, Sanquer E, Kadlub N. Normative data on nasalance scores for French speaking children. J Stomatol Oral Maxillofac Surg. 2025 Jun;126(3):102089. doi: 10.1016/j.jormas.2024.102089. Epub 2024 Sep 21.

Reference Type: BACKGROUND

PMID: 39313155 (View on PubMed)

Other Identifiers

2021-A00452-39

Identifier Type: OTHER

Identifier Source: secondary_id

APHP210445

Identifier Type: -

Identifier Source: org_study_id