<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03259061</url>
  </required_header>
  <id_info>
    <org_study_id>Border line VPI study</org_study_id>
    <nct_id>NCT03259061</nct_id>
  </id_info>
  <brief_title>A Study of Border Line Cases of Velopharyngeal Incompetence Using Cephalometry and Nasofibroscopy</brief_title>
  <official_title>A Study of Border Line Cases of Velopharyngeal Incompetence and Insufficiency Using Cephalometry and Nasofibroscopy</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Assiut University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Assiut University</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The aim of this work is to evaluate the role of cephalometry &amp;nasofibroscopy as objective&#xD;
      tools in order to confirm the diagnosis based upon the clinical judgment of border line cases&#xD;
      suspected to have velopharyngeal incompetence or insufficiency.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The velopharyngeal mechanism is constituted by the muscles of the soft palate, posterior and&#xD;
      lateral pharyngeal walls (1), separating the oropharynx from the nasopharynx. Such&#xD;
      structures, particularly the soft palate, play a key role in the velopharyngeal closure&#xD;
      physiology (2). Velopharyngeal closure patterns may be classified as follows: coronal, where&#xD;
      there is predominant soft palate movement toward the posterior pharyngeal wall; sagittal,&#xD;
      where there is predominant movement of the lateral pharyngeal walls toward the pharynx&#xD;
      midline; circular, where balanced movements of lateral pharyngeal walls and soft palate are&#xD;
      observed; circular with Passavant's ridge, where the circular closure is associated with the&#xD;
      development of a mucosal fold named Passavant's ridge on the posterior pharyngeal wall(3).&#xD;
      The velopharyngeal closure allows the separation between the nasal and oral cavities during&#xD;
      activities such as oral sounds emission, blowing, whistling, swallowing, sucking and vomiting&#xD;
      reflex, respecting the level of closure demanded by each activity (4,5).&#xD;
&#xD;
      In cases where the structures of the velopharyngeal mechanism do not work properly, the&#xD;
      presence of a space called velopharyngeal aperture is observed between them, characterizing a&#xD;
      velopharyngeal dysfunction. One of the reasons for the occurrence of such an aperture is the&#xD;
      shortage of soft palate tissue. This dysfunction is called velopharyngeal insufficiency and&#xD;
      may be corrected either surgically or by prosthetic management followed by speech therapy. In&#xD;
      cases where such dysfunction occurs because of a failure in the velopharyngeal structures&#xD;
      movement, physiological or neuromotor deficiency, it is called velopharyngeal incompetence&#xD;
      that may be eliminated by means of speech therapy (2,6). On the other hand, if such condition&#xD;
      is a result of the presence of compensatory articulations or other speech learning errors, it&#xD;
      does not reflect physical or neuromuscular alterations, constituting indication for speech&#xD;
      therapy(7). Individuals with velopharyngeal dysfunction present hypernasality, nasal air&#xD;
      emission, poor intraoral pressure, and may present associated nasal/facial movements and&#xD;
      compensatory articulations during the emission of oral consonants (8,9).&#xD;
&#xD;
      Assessment of the velopharyngeal function can be done by the following procedures:&#xD;
&#xD;
        1. Flexible fiberoptic nasopharyngoscopy (FFN) allows direct transnasal observation of the&#xD;
           anatomy and dynamic activity of the velopharyngeal sphincter. Such observations can be&#xD;
           recorded for permanent documentation by coupling FFN to a video camera with simultaneous&#xD;
           audio recording. Numerous published reports discuss the advantages of FFN as a clinical&#xD;
           method for evaluating velopharyngeal function during speech (10).&#xD;
&#xD;
           Flexible fiberoptic nasopharyngoscopy (FFN) is a valuable tool for direct visualization&#xD;
           because it allows observation of the velopharyngeal valve during dynamic activity for a&#xD;
           prolonged period with (1) Minimal interference of the structures involved and (2) No&#xD;
           radiation exposure. Whereas most clinicians acknowledge the theoretic advantages of FFN&#xD;
           and accept it as a valid technique for assessing velopharyngeal function, there are few&#xD;
           published studies that have addressed the validity and reliability of endoscopic&#xD;
           procedures (10). Endoscopic evaluation has high face validity, and several reports have&#xD;
           indicated that FFN has good construct validity when compared with radiologic assessments&#xD;
           (11).&#xD;
&#xD;
        2. Cephalometric analysis, is the clinical application of cephalometry. It is analysis of&#xD;
           the dental and skeletal relationships of a human skull and is frequently used by&#xD;
           dentists, orthodontists, and oral and maxillofacial surgeons as a treatment planning&#xD;
           tool.&#xD;
&#xD;
      Cephalometric analysis can also be applied for assessing the velopharyngeal structure and&#xD;
      function. More specifically, velopharyngeal function in terms of its shape and mobility was&#xD;
      analyzed quantitatively on the basis of cephalometric principle (12,13).&#xD;
&#xD;
      Border line cases of velopharyngeal incompetence of insufficiency are known to be problematic&#xD;
      and usually causes confusion for phoniatricians especially in patients who will undergo&#xD;
      adenotonsillectomy. For this purpose, objective assessment is necessary to support or reject&#xD;
      the clinical findings of VPI cases.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">September 1, 2017</start_date>
  <completion_date type="Anticipated">November 2019</completion_date>
  <primary_completion_date type="Anticipated">September 2019</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Comparison between Cephalometric and nasofibroscopic findings and clinical findings</measure>
    <time_frame>Baseline</time_frame>
    <description>Assessment of the function of velopharyngeal valve by nasofibroscopy and cephalometric measurements in clinically border line cases of velopharyngeal incompetence in order to ensure the presence of Velophayngeal incompetence</description>
  </primary_outcome>
  <enrollment type="Anticipated">50</enrollment>
  <condition>Velopharyngeal Insufficiency</condition>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Flexible fiberoptic nasopharyngoscopy</intervention_name>
    <description>Flexible fiberoptic nasopharyngoscopy (FFN) allows direct transnasal observation of the anatomy and dynamic activity of the velopharyngeal sphincter. Such observations can be recorded for permanent documentation by coupling FFN to a video camera with simultaneous audio recording. Numerous published reports discuss the advantages of FFN as a clinical method for evaluating velopharyngeal function during speech (10).&#xD;
Cephalometric analysis, is the clinical application of cephalometry. It is analysis of the dental and skeletal relationships of a human skull and is frequently used by dentists, orthodontists, and oral and maxillofacial surgeons as a treatment planning tool.&#xD;
Cephalometric analysis can also be applied for assessing the velopharyngeal structure and function. More specifically, velopharyngeal function in terms of its shape and mobility was analyzed quantitatively on the basis of cephalometric principle</description>
    <other_name>Cephalometry</other_name>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Any&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Patients must have border line velopharyngeal abnormality which was diagnosed clinically.&#xD;
&#xD;
        Ability to understand and the willingness to sign a written informed consent(if he was a&#xD;
        child so his parents or his guardian should has tis ability)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Mental Retardation.&#xD;
&#xD;
          2. Presence of Neurological deficit affecting speech.&#xD;
&#xD;
          3. Palatal paralysis or paresis.&#xD;
&#xD;
          4. Overt cleft palate.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Abdelazez Darwesh, doctor</last_name>
    <phone>+201002600619</phone>
    <email>dr.abdelazez.darwesh@gmail.com</email>
  </overall_contact>
  <reference>
    <citation>Camargo LO, Rodrigues CM, Avelar JA. Oclusão velofaríngea em indivíduos submetidos à nasoendoscopia na Clínica de Educação para Saúde (CEPS) 20(1):35-48, 2001.</citation>
  </reference>
  <reference>
    <citation>Skolnick ML, McCALL GN, Barnes M. The sphincteric mechanism of velopharyngeal closure. Cleft Palate J. 1973 Jul;10:286-305. No abstract available.</citation>
    <PMID>4513919</PMID>
  </reference>
  <reference>
    <citation>Penido FA, Noronha RM, Caetano KI, Jesus MS, Di Ninno CQ, Britto AT. Correlação entre os achados do teste de emissão de ar nasal e da nasofaringoscopia em pacientes com fissura labiopalatina operada. Rev Soc Bras Fonoaudiol. 2007;12(2):126-34.</citation>
  </reference>
  <reference>
    <citation>Mourão D, Souza GS, Torres LV, Vaz RN, Prado SG. Estudo sobre desenvolvimento fonológico em fissurados: implicações na fala e na linguagem. Estudos. 2006;33(5/6):425-41.</citation>
  </reference>
  <reference>
    <citation>De Bodt M, Van Lierde K. Cleft palate speech and velopharyngeal dysfunction: the approach of the speech therapist. B-ENT. 2006;2 Suppl 4:63-70.</citation>
    <PMID>17366850</PMID>
  </reference>
  <reference>
    <citation>Trindade IE, Genaro KF, Yamashita RP, Miguel HC, Fukushiro AP. [Proposal for velopharyngeal function rating in a speech perceptual assessment]. Pro Fono. 2005 May-Aug;17(2):259-62. doi: 10.1590/s0104-56872005000200015. Portuguese.</citation>
    <PMID>16909536</PMID>
  </reference>
  <reference>
    <citation>Witt PD. Management of velopharyngeal dysfunction. In: Persing JA, Evans GR. Soft-tissue surgery of the craniofacial region. New York: Informa; 2007. p.113-28.</citation>
  </reference>
  <reference>
    <citation>Smith BE, Kuehn DP. Speech evaluation of velopharyngeal dysfunction. J Craniofac Surg. 2007 Mar;18(2):251-61; quiz 266-7. doi: 10.1097/SCS.0b013e31803ecf3b.</citation>
    <PMID>17414269</PMID>
  </reference>
  <reference>
    <citation>D'Antonio LL, Marsh JL, Province MA, Muntz HR, Phillips CJ. Reliability of flexible fiberoptic nasopharyngoscopy for evaluation of velopharyngeal function in a clinical population. Cleft Palate J. 1989 Jul;26(3):217-25; discussion 225.</citation>
    <PMID>2758674</PMID>
  </reference>
  <reference>
    <citation>Mourino AP, Weinberg B. A cephalometric study of velar stretch in 8 and 10-year old children. Cleft Palate J. 1975 Oct;12:417-35.</citation>
    <PMID>1058753</PMID>
  </reference>
  <reference>
    <citation>Simpson RK, Colton J. A cephalometric study of velar stretch in adolescent subjects. Cleft Palate J. 1980 Jan;17(1):40-7.</citation>
    <PMID>6928116</PMID>
  </reference>
  <verification_date>August 2017</verification_date>
  <study_first_submitted>August 19, 2017</study_first_submitted>
  <study_first_submitted_qc>August 19, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 23, 2017</study_first_posted>
  <last_update_submitted>August 19, 2017</last_update_submitted>
  <last_update_submitted_qc>August 19, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">August 23, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Assiut University</investigator_affiliation>
    <investigator_full_name>AbdElAzeez Mohammad Faheem Darweesh</investigator_full_name>
    <investigator_title>Dr</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Velopharyngeal Insufficiency</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03259061
org study id: Border line VPI study
nct id: NCT03259061
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
The aim of this work is to evaluate the role of cephalometry &nasofibroscopy as objective
      tools in order to confirm the diagnosis based upon the clinical judgment of border line cases
      suspected to have velopharyngeal incompetence or insufficiency.
The velopharyngeal mechanism is constituted by the muscles of the soft palate, posterior and
      lateral pharyngeal walls (1), separating the oropharynx from the nasopharynx. Such
      structures, particularly the soft palate, play a key role in the velopharyngeal closure
      physiology (2). Velopharyngeal closure patterns may be classified as follows: coronal, where
      there is predominant soft palate movement toward the posterior pharyngeal wall; sagittal,
      where there is predominant movement of the lateral pharyngeal walls toward the pharynx
      midline; circular, where balanced movements of lateral pharyngeal walls and soft palate are
      observed; circular with Passavant's ridge, where the circular closure is associated with the
      development of a mucosal fold named Passavant's ridge on the posterior pharyngeal wall(3).
      The velopharyngeal closure allows the separation between the nasal and oral cavities during
      activities such as oral sounds emission, blowing, whistling, swallowing, sucking and vomiting
      reflex, respecting the level of closure demanded by each activity (4,5).

      In cases where the structures of the velopharyngeal mechanism do not work properly, the
      presence of a space called velopharyngeal aperture is observed between them, characterizing a
      velopharyngeal dysfunction. One of the reasons for the occurrence of such an aperture is the
      shortage of soft palate tissue. This dysfunction is called velopharyngeal insufficiency and
      may be corrected either surgically or by prosthetic management followed by speech therapy. In
      cases where such dysfunction occurs because of a failure in the velopharyngeal structures
      movement, physiological or neuromotor deficiency, it is called velopharyngeal incompetence
      that may be eliminated by means of speech therapy (2,6). On the other hand, if such condition
      is a result of the presence of compensatory articulations or other speech learning errors, it
      does not reflect physical or neuromuscular alterations, constituting indication for speech
      therapy(7). Individuals with velopharyngeal dysfunction present hypernasality, nasal air
      emission, poor intraoral pressure, and may present associated nasal/facial movements and
      compensatory articulations during the emission of oral consonants (8,9).

      Assessment of the velopharyngeal function can be done by the following procedures:

        1. Flexible fiberoptic nasopharyngoscopy (FFN) allows direct transnasal observation of the
           anatomy and dynamic activity of the velopharyngeal sphincter. Such observations can be
           recorded for permanent documentation by coupling FFN to a video camera with simultaneous
           audio recording. Numerous published reports discuss the advantages of FFN as a clinical
           method for evaluating velopharyngeal function during speech (10).

           Flexible fiberoptic nasopharyngoscopy (FFN) is a valuable tool for direct visualization
           because it allows observation of the velopharyngeal valve during dynamic activity for a
           prolonged period with (1) Minimal interference of the structures involved and (2) No
           radiation exposure. Whereas most clinicians acknowledge the theoretic advantages of FFN
           and accept it as a valid technique for assessing velopharyngeal function, there are few
           published studies that have addressed the validity and reliability of endoscopic
           procedures (10). Endoscopic evaluation has high face validity, and several reports have
           indicated that FFN has good construct validity when compared with radiologic assessments
           (11).

        2. Cephalometric analysis, is the clinical application of cephalometry. It is analysis of
           the dental and skeletal relationships of a human skull and is frequently used by
           dentists, orthodontists, and oral and maxillofacial surgeons as a treatment planning
           tool.

      Cephalometric analysis can also be applied for assessing the velopharyngeal structure and
      function. More specifically, velopharyngeal function in terms of its shape and mobility was
      analyzed quantitatively on the basis of cephalometric principle (12,13).

      Border line cases of velopharyngeal incompetence of insufficiency are known to be problematic
      and usually causes confusion for phoniatricians especially in patients who will undergo
      adenotonsillectomy. For this purpose, objective assessment is necessary to support or reject
      the clinical findings of VPI cases.
observational model: Cohort
time perspective: Prospective
measure: Comparison between Cephalometric and nasofibroscopic findings and clinical findings
time frame: Baseline
description: Assessment of the function of velopharyngeal valve by nasofibroscopy and cephalometric measurements in clinically border line cases of velopharyngeal incompetence in order to ensure the presence of Velophayngeal incompetence
intervention type: Device
intervention name: Flexible fiberoptic nasopharyngoscopy
description: Flexible fiberoptic nasopharyngoscopy (FFN) allows direct transnasal observation of the anatomy and dynamic activity of the velopharyngeal sphincter. Such observations can be recorded for permanent documentation by coupling FFN to a video camera with simultaneous audio recording. Numerous published reports discuss the advantages of FFN as a clinical method for evaluating velopharyngeal function during speech (10).
Cephalometric analysis, is the clinical application of cephalometry. It is analysis of the dental and skeletal relationships of a human skull and is frequently used by dentists, orthodontists, and oral and maxillofacial surgeons as a treatment planning tool.
Cephalometric analysis can also be applied for assessing the velopharyngeal structure and function. More specifically, velopharyngeal function in terms of its shape and mobility was analyzed quantitatively on the basis of cephalometric principle
other name: Cephalometry
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Abdelazez Darwesh, doctor
phone: +201002600619
email: dr.abdelazez.darwesh@gmail.com
citation: Camargo LO, Rodrigues CM, Avelar JA. Oclusão velofaríngea em indivíduos submetidos à nasoendoscopia na Clínica de Educação para Saúde (CEPS) 20(1):35-48, 2001.
citation: Skolnick ML, McCALL GN, Barnes M. The sphincteric mechanism of velopharyngeal closure. Cleft Palate J. 1973 Jul;10:286-305. No abstract available.
PMID: 4513919
citation: Penido FA, Noronha RM, Caetano KI, Jesus MS, Di Ninno CQ, Britto AT. Correlação entre os achados do teste de emissão de ar nasal e da nasofaringoscopia em pacientes com fissura labiopalatina operada. Rev Soc Bras Fonoaudiol. 2007;12(2):126-34.
citation: Mourão D, Souza GS, Torres LV, Vaz RN, Prado SG. Estudo sobre desenvolvimento fonológico em fissurados: implicações na fala e na linguagem. Estudos. 2006;33(5/6):425-41.
citation: De Bodt M, Van Lierde K. Cleft palate speech and velopharyngeal dysfunction: the approach of the speech therapist. B-ENT. 2006;2 Suppl 4:63-70.
PMID: 17366850
citation: Trindade IE, Genaro KF, Yamashita RP, Miguel HC, Fukushiro AP. [Proposal for velopharyngeal function rating in a speech perceptual assessment]. Pro Fono. 2005 May-Aug;17(2):259-62. doi: 10.1590/s0104-56872005000200015. Portuguese.
PMID: 16909536
citation: Witt PD. Management of velopharyngeal dysfunction. In: Persing JA, Evans GR. Soft-tissue surgery of the craniofacial region. New York: Informa; 2007. p.113-28.
citation: Smith BE, Kuehn DP. Speech evaluation of velopharyngeal dysfunction. J Craniofac Surg. 2007 Mar;18(2):251-61; quiz 266-7. doi: 10.1097/SCS.0b013e31803ecf3b.
PMID: 17414269
citation: D'Antonio LL, Marsh JL, Province MA, Muntz HR, Phillips CJ. Reliability of flexible fiberoptic nasopharyngoscopy for evaluation of velopharyngeal function in a clinical population. Cleft Palate J. 1989 Jul;26(3):217-25; discussion 225.
PMID: 2758674
citation: Mourino AP, Weinberg B. A cephalometric study of velar stretch in 8 and 10-year old children. Cleft Palate J. 1975 Oct;12:417-35.
PMID: 1058753
citation: Simpson RK, Colton J. A cephalometric study of velar stretch in adolescent subjects. Cleft Palate J. 1980 Jan;17(1):40-7.
PMID: 6928116
responsible party type: Principal Investigator
investigator affiliation: Assiut University
investigator full name: AbdElAzeez Mohammad Faheem Darweesh
investigator title: Dr
mesh term: Velopharyngeal Insufficiency