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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT03898713
Other study ID # IQ In VPI patients
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date July 1, 2019
Est. completion date July 1, 2020

Study information

Verified date July 2019
Source Assiut University
Contact Zeinab Soliman, Resident Dr.
Phone 01018119004
Email smile0smile@hotmail.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

To Assess effect of intelligence on speech production on subjects with velopharyngeal incompetence Search if there is any relation between congenital Velopharyngeal incompetence and decrease IQ of patients


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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 100
Est. completion date July 1, 2020
Est. primary completion date July 1, 2020
Accepts healthy volunteers
Gender All
Age group 3 Years to 25 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Diagnostic Test:
Intelligence quotient
intelligence quotient (IQ) is a total score derived from several standardized tests designed to assess human intelligence

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Assiut University

References & Publications (3)

Levelt WJ. Models of word production. Trends Cogn Sci. 1999 Jun;3(6):223-232. — View Citation

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. Review. — View Citation

Waitzman NJ, Romano PS, Scheffler RM. Estimates of the economic costs of birth defects. Inquiry. 1994 Summer;31(2):188-205. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Auditory perceptual assessment 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
Primary IQ test 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
See also
  Status Clinical Trial Phase
Not yet recruiting NCT03469973 - Partial Adenoidectomy in Cases of Velopharyngeal Dysfunction
Not yet recruiting NCT05492266 - Expiratory Muscle Strength Training for Hypernasal Speech in Children N/A
Terminated NCT03868891 - Exercises for Improving Soft Palate and Eustachian Tube Function in Children With Ear Tubes With or Without Cleft Palate N/A

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