Nasalance Scores for Normal-speaking French Children (NONAFRA2022)

Normative Nasalance Scores for Native French-speaking Children

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.

Study Overview

• Status: Completed
• Conditions: Resonance Disorder
• Intervention / Treatment: Other: Nasometry

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.

• Study Type: Observational
• Enrollment (Actual): 131

Contacts and Locations

• Study Contact: Name: Natacha KADLUB, MD, PhD; Phone Number: +33 1 71 39 67 54; Email: natacha.kadlub@aphp.fr
• Study Contact Backup: Name: Hélène Morel; Phone Number: +33 1 71 19 63 46; Email: helene.morel@aphp.fr

Study Locations

• France
  • Paris, France, 75015
    • Hopital Necker-Enfants Malades

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 8 years to 10 years (Child)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients followed by the Pediatric ENT department of Necker-Enfants Malades hospital

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Cross-Sectional

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Patients without cleft; Patients without developmental speech disorder (including articulation disorder) or hearing impairment	Other: Nasometry; 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	Other: Nasometry; Repetition of several stimuli (syllables, sentences ) in the microphones of the Nasometer

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Nasalance score for each stimulus	Average value of nasalance score for each stimulus	Day 0
Nasalance score per context	Average value of nasalance score per context (oral - nasal)	Day 0
Nasalance score of the nasalance distance	Average value of the nasalance distance (difference between the average in a nasal context and the average in an oral context)	Day 0

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Effect of the context on the nasalance scores	Effect of the context (oral / nasal) on the nasalance scores: comparison of the mean, minimum and maximum measurements between the two contexts	Day 0
Speech stimulus length effect on the nasalance scores	Check whether there is a speech stimulus length effect: are the nasalance scores comparable between repeating an oral short sentence and an oral long sentence, provided that the phonemic distribution is identical? Comparison of the average, minimum and maximum scores between the two stimuli	Day 0
Effect of the phonetic context on the nasalance scores	Check if there is an effect of the phonetic context (types of vowels and consonants) on the nasalance scores: comparison of the mean, minimum and maximum scores between for example high vowels ([i]) and low ([a]) or between voiceless ([k]) and voiced ([g]) consonants	Day 0
Test-retest reliability of the nasalance scores	Evaluate the test-retest reliability: selection of a few subjects who will repeat the stimuli twice. Analyze if there is a significant difference between the two repetitions	Day 0
Most relevant stimuli for a nasometric protocol	Validate the nasometric evaluation protocol for its clinical use : on the basis of speech therapy assessment results, determine the best time / efficiency ratio and choose the most relevant stimuli in order to have the maximum information in a minimum of time	Day 0
Analysis of acoustic signals captured by standard microphones	Compare the nasalance score obtained with the Nasometer with a nasalance score calculated on the basis of acoustic signals captured at the same time by standard microphones placed on the Nasometer plate: compare the average, minimum and maximum values between the two recordings of acoustic signals	Day 0

Collaborators and Investigators

• Sponsor: Assistance Publique - Hôpitaux de Paris
• Investigators: Principal Investigator: Natacha KADLUB, MD, PhD, Assistance Publique - Hôpitaux de Paris; Study Director: Cécile CHAPUIS-VANDENBOGAERDE, MD, Assistance Publique - Hôpitaux de Paris

Study record dates

Study Major Dates

• Study Start (Actual): September 16, 2021
• Primary Completion (Actual): January 24, 2024
• Study Completion (Actual): January 24, 2024

Study Registration Dates

• First Submitted: June 14, 2021
• First Submitted That Met QC Criteria: June 14, 2021
• First Posted (Actual): June 22, 2021

Study Record Updates

• Last Update Posted (Actual): February 28, 2024
• Last Update Submitted That Met QC Criteria: February 26, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: Nasometer; Nasometry; Nasalance scores; Velopharyngeal dysfunction
• Other Study ID Numbers: APHP210445; 2021-A00452-39 (Other Identifier: IDRCB)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No