- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03898713
Assessment of Intellectual Abilities for Subjects With Velopharyngeal Incompetence and Their Impact on Speech Intelligibility
Study Overview
Status
Intervention / Treatment
Detailed Description
Speech production is a complex process by which thoughts are generated into spoken utterances. Production involves the selection of appropriate words and the appropriate form of those words from the lexicon and morphology, and the organization of those words through the syntax. Then, the phonetic properties of the words are retrieved and the sentence is uttered through the articulations associated with those phonetic properties.
The term intelligibility refers to 'speech clarity' or the proportion of a speaker's output that a listener can readily understand.
Velopharyngeal Incompetence (VPI) refers to any situation in which an individual is unable to completely close the nasal airway during speech. The velopharyngeal mechanism is comprised of a complex group of structures that act in unison to control airflow through the nose and mouth by elevation of the soft palate and constriction of both the lateral and posterior pharyngeal walls. Any disruption in this mechanism may result in abnormal, poorly intelligible speech. VPI can manifest as hypernasality, nasal emission, decreased vocal intensity, and/or facial grimacing.
Intellectual ability refers to the skills required to think critically, see connections between disciplines and problem solve in new or changing situations. Memory, creative problem solving and vocabulary also contribute to the level of an individual's intellectual ability.
Orofacial clefts (OFCs) are frequently occurring human birth defects that have a complex, multifactorial etiology. Though structural orofacial defects are often surgically corrected during infancy and early childhood, OFC patient cohorts are at high risk for neurobehavioral problems including learning disability, impaired language function, psychosocial adjustment issues, and persistently reduced academic achievement.
Study Type
Enrollment (Anticipated)
Contacts and Locations
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- children with cleft lip and palate primary or secondary repaired
- Velopharyngeal incompetence due to any cause especially short palate and deep pharynx
- children above 3 years
Exclusion Criteria:
- Hearing impairment
- Neurological disease
- ADHD
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Auditory perceptual assessment
Time Frame: Baseline
|
Auditory-perceptual evaluation is the most commonly used clinical voice assessment method, and is often considered a gold standard for documentation of voice disorders.
|
Baseline
|
|
IQ test
Time Frame: Baseline
|
Assess IQ level of patients by standford binet version 4. An intelligence quotient (IQ) is a total score derived from several standardized tests designed to assess human intelligence. This is to search if there is any relation between IQ level and VPI and effect on speech intelligability |
Baseline
|
Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- Levelt WJ. Models of word production. Trends Cogn Sci. 1999 Jun;3(6):223-232. doi: 10.1016/s1364-6613(99)01319-4.
- Robin NH, Baty H, Franklin J, Guyton FC, Mann J, Woolley AL, Waite PD, Grant J. The multidisciplinary evaluation and management of cleft lip and palate. South Med J. 2006 Oct;99(10):1111-20. doi: 10.1097/01.smj.0000209093.78617.3a.
- Waitzman NJ, Romano PS, Scheffler RM. Estimates of the economic costs of birth defects. Inquiry. 1994 Summer;31(2):188-205.
Helpful Links
Study record dates
Study Major Dates
Study Start (Anticipated)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Congenital Abnormalities
- Musculoskeletal Diseases
- Pharyngeal Diseases
- Stomatognathic Diseases
- Otorhinolaryngologic Diseases
- Mouth Diseases
- Mouth Abnormalities
- Stomatognathic System Abnormalities
- Jaw Abnormalities
- Jaw Diseases
- Maxillofacial Abnormalities
- Craniofacial Abnormalities
- Musculoskeletal Abnormalities
- Cleft Palate
- Velopharyngeal Insufficiency
Other Study ID Numbers
- IQ In VPI patients
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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