Speech Outcome After Partial Adenoidectomy in Patients With Risk of Hypernasality

March 1, 2022 updated by: Dina Awida Hasb Allah, Sohag University
Adenoid hypertrophy is a common cause of airway obstruction in children; it may lead to mouth breathing, nasal discharge, snoring, sleep apnea, and hyponasal speech.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Adenoid hypertrophy is a common cause of airway obstruction in children; it may lead to mouth breathing, nasal discharge, snoring, sleep apnea, and hyponasal speech. It also contributes to the pathogenesis of rhinosinusitis and recurrent otitis media. However, the adenoid lies in the posterior nasopharyngeal wall and may act as a pad against the palate facilitating velopharyngeal closure, especially in patients with palatal abnormalities; Its presence can compensate for a short or poorly mobile palate. Following adenoidectomy, compensation is eliminated and velopharyngeal insufficiency (VPI) may result. Therefore, patients with palatal abnormalities (such as poor palatal mobility, short palate, occult submucosal cleft palate, scarred palate after previous tonsillectomy, and repaired cleft palate) are at high risk to develop hypernasality after complete adenoidectomy, and in such situations conservative or partial adenoidectomy is performed

Study Type

Interventional

Enrollment (Anticipated)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Egypt
      • Sohag, Egypt
        • Recruiting
        • Sohag faculty of medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 year to 12 years (CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Patient with symptoms of adenoid hypertrophy.

  2. High risk to VPI:

    1. Short palate.
    2. Scarred palate after previous tonsillectomy.
    3. Occult submucous cleft.
    4. Deep pharynx.
    5. Repaired cleft palate.

Exclusion Criteria:

  • Any neurological deficit, muscular disorder or structural defects of the palate (as cleft palate).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
OTHER: Patients with high risk of hypernasality
In 1958, Gibb indicated an incidence of hypernasality (escape of air from nose as in patients with cleft palate) postadenoidectomy in approximately 1of 2000 cases. Closure pattern of velopharyngeal valve in children is veloadenoidal rather than velopharyngeal closure. Adenoid tissue is vital to velopharyngeal closure in children and its removal necessitates a change in the closure pattern of velopharyngeal valving. These changes are easily overcome if there is no anatomic abnormality
Procedure: Partial Adenoidectomy
Partial removal of adenoid

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Speech Outcome
Time Frame: 1 month after operation
Change of a degree of Nasal Tone during speech
1 month after operation
Speech Outcome
Time Frame: 3 months after operation
Change of a degree of Nasal Tone during speech
3 months after operation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sohag University

Investigators

  • Study Chair: Mohammed AE Ahmed, Professor, Sohag faculty of medicine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

February 4, 2022

Primary Completion (ANTICIPATED)

August 4, 2022

Study Completion (ANTICIPATED)

December 1, 2022

Study Registration Dates

First Submitted

February 18, 2022

First Submitted That Met QC Criteria

March 1, 2022

First Posted (ACTUAL)

March 10, 2022

Study Record Updates

Last Update Posted (ACTUAL)

March 10, 2022

Last Update Submitted That Met QC Criteria

March 1, 2022

Last Verified

March 1, 2022

More Information

Terms related to this study

Other Study ID Numbers

  • DAHAllah

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Hypernasality

Clinical Trials on Partial Adenoidectomy

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Gambia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe