Assessment of Intellectual Abilities for Subjects With Velopharyngeal Incompetence and Their Impact on Speech Intelligibility

NCT ID: NCT03898713

Last Updated: 2019-07-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-07-01

Study Completion Date

2020-07-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Velopharyngeal Incompetence Due to Cleft Palate

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Intelligence quotient

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

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

3 Years

Maximum Eligible Age

25 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Assiut University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Zeinab Abdel Ghani Abdel Hameed Mohamed

principle investigator at phoniatric department

Responsibility Role PRINCIPAL_INVESTIGATOR

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Zeinab Soliman, Resident Dr.

Role: CONTACT

01018119004

Eman Abdel Haleem, Prof. Dr.

Role: CONTACT

01064228598

References

Explore related publications, articles, or registry entries linked to this study.

Levelt WJ. Models of word production. Trends Cogn Sci. 1999 Jun;3(6):223-232. doi: 10.1016/s1364-6613(99)01319-4.

Reference Type BACKGROUND
PMID: 10354575 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 17100032 (View on PubMed)

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

Reference Type BACKGROUND
PMID: 8021024 (View on PubMed)

Related Links

Access external resources that provide additional context or updates about the study.

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

IQ In VPI patients

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.