Clinical trial NCT04934306: Nasalance Scores for Normal-speaking French Children
Official title: Normative Nasalance Scores for Native French-speaking Children
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Resonance Disorder
Keywords: Nasometer
Nasometry
Nasalance scores
Velopharyngeal dysfunction
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2021-06-22
Enrollment: 131
Sex: ALL
Minimum age (years): 8
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients followed by the Pediatric ENT department of Necker-Enfants Malades hospital

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.

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

Primary outcomes:
measure: Nasalance score for each stimulus
timeFrame: Day 0
measure: Nasalance score per context
timeFrame: Day 0
measure: Nasalance score of the nasalance distance
timeFrame: Day 0
Secondary outcomes:
measure: Effect of the context on the nasalance scores
timeFrame: Day 0
measure: Speech stimulus length effect on the nasalance scores
timeFrame: Day 0
measure: Effect of the phonetic context on the nasalance scores
timeFrame: Day 0
measure: Test-retest reliability of the nasalance scores
timeFrame: Day 0
measure: Most relevant stimuli for a nasometric protocol
timeFrame: Day 0
measure: Analysis of acoustic signals captured by standard microphones
timeFrame: Day 0
Other outcomes:
Locations:
city: Paris
country: France
facility: Hôpital Necker-Enfants Malades
Study officials:
affiliation: Assistance Publique - Hôpitaux de Paris
name: Natacha KADLUB, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Assistance Publique - Hôpitaux de Paris
name: Cécile CHAPUIS-VANDENBOGAERDE, MD
role: STUDY_DIRECTOR
References: