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临床试验/NCT04934306
NCT04934306已完成不适用

Normative Nasalance Scores for Native French-speaking Children

Assistance Publique - Hôpitaux de Paris1 个研究点 分布在 1 个国家目标入组 131 人开始时间: 2021年9月16日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
131
试验地点
1
主要终点
Nasalance score of the nasalance distance

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Cross Sectional

入排标准

年龄范围
8 Years 至 10 Years(Child)
性别
All
接受健康志愿者
否

入选标准

  • •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

排除标准

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

研究组 & 干预措施

Patients without cleft

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

干预措施: Nasometry (Other)

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

干预措施: Nasometry (Other)

结局指标

主要结局

Nasalance score of the nasalance distance

时间窗: Day 0

Average value of the nasalance distance (difference between the average in a nasal context and the average in an oral context)

Nasalance score for each stimulus

时间窗: Day 0

Average value of nasalance score for each stimulus

Nasalance score per context

时间窗: Day 0

Average value of nasalance score per context (oral - nasal)

次要结局

  • Analysis of acoustic signals captured by standard microphones(Day 0)
  • Effect of the context on the nasalance scores(Day 0)
  • Effect of the phonetic context on the nasalance scores(Day 0)
  • Test-retest reliability of the nasalance scores(Day 0)
  • Most relevant stimuli for a nasometric protocol(Day 0)
  • Speech stimulus length effect on the nasalance scores(Day 0)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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