NCT03898713

Brief 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

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jul 2019

Shorter than P25 for all trials

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 24, 2019

Completed
9 days until next milestone

First Posted

Study publicly available on registry

April 2, 2019

Completed
3 months until next milestone

Study Start

First participant enrolled

July 1, 2019

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2020

Completed
Last Updated

July 5, 2019

Status Verified

July 1, 2019

Enrollment Period

1 year

First QC Date

March 24, 2019

Last Update Submit

July 1, 2019

Conditions

Keywords

IQSpeechVPI

Outcome Measures

Primary Outcomes (2)

  • 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

  • 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

Interventions

Intelligence quotientDIAGNOSTIC_TEST

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

Eligibility Criteria

Age3 Years - 25 Years
Sexall
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Patients will be collected randomly for one year from phoniatric department at Assiut university Hospital.

You may qualify if:

  • 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

You may not qualify if:

  • Hearing impairment
  • Neurological disease
  • ADHD

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (3)

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

    PMID: 10354575BACKGROUND
  • 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.

    PMID: 17100032BACKGROUND
  • Waitzman NJ, Romano PS, Scheffler RM. Estimates of the economic costs of birth defects. Inquiry. 1994 Summer;31(2):188-205.

    PMID: 8021024BACKGROUND

Related Links

MeSH Terms

Conditions

Speech

Condition Hierarchy (Ancestors)

Verbal BehaviorCommunicationBehavior

Central Study Contacts

Zeinab Soliman, Resident Dr.

CONTACT

Eman Abdel Haleem, Prof. Dr.

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
principle investigator at phoniatric department

Study Record Dates

First Submitted

March 24, 2019

First Posted

April 2, 2019

Study Start

July 1, 2019

Primary Completion

July 1, 2020

Study Completion

July 1, 2020

Last Updated

July 5, 2019

Record last verified: 2019-07