Effect of Chronic Rhinosinusitis on Voice of Children

October 3, 2018 updated by: Sahar Sabri Abdelraheem, Assiut University

Impact of Chronic Rhinosinusitis on the Laryngeal Mucosa and Voice Quality in Children Aged From 6- to 18- Years Old

Evaluation of the effect of chronic rhinosinusitis on the laryngeal mucosa and voice quality in children. This is important to know factors affecting voice disorders

Study Overview

Status

Unknown

Intervention / Treatment

Detailed Description

The voice is that the carrier wave of verbal communication. It's created within the voice box l by vibrations of the mucous membrane of the vocal folds leading to the assembly of the first laryngeal sound. It depends on the larynx that's the voice generator, the oral fissure beside the tongue and teeth that articulate the voice, and therefore the nose with the paranasal sinuses that participate in the resonance.

Any disruption of the performance of voice is termed dysphonia. Dysphonia is outlined as perceptual audible deviation of a patient's habitual voice as self-judged or judged by his or her listeners .

"Hoarseness" or "dysphonia" are terms usually used to describe a change within the quality of the voice in which the voice are often raspy, breathy, strained, fatigued, rough, tremulous, or asthenic. There is also a change in pitch, loudness or voice breaks. The prevalence of hoarseness in children ranges from 6 to 23 percent . Boys were statistically more probably to have dysphonia (7.5%) over girls (4.6%) . the etiology of childhood dysphonia is multifactorial and factors that in previous studies have been connected to dysphonia are health- related factors , personality triats, and environmental factors . Health related factors such as recurrent inflammation of respiratory airway, Allergy and chronic cough. Personality triats such as hyperactivity and impulsiveness, besides previous history of excessive crying, Environmental factors such as pollution by noise, dryness, cold air or dust and fumes.the most common laryngeal diagnosis for children with hoarseness in a treatment - seeking population was vocal fold nodules, followed by vocal cysts, and acute laryngitis. They attribute this to vocal overuse or misuse.

Chronic rhinosinusitis is a frequently noticable condition in otorhinolaryngology clinic. 5 % to 13% of childhood viral upper airway infections may lead to acute rhinosinusitis, with a proportion of these to progress to a chronic rhinosinusitis. Chronic rhinosinusitis is defined as a minimum of ninty continuous days of two or additional symptoms of infected rhinorrhea, nasal blockage, headache, or cough and either endoscopic signs of nasal mucosal swelling and oedema, mucopurulent nasal discharge, or nasal polyposis may be associated with CT scan findings showing mucosal changes within the ostiomeatal complex and/or sinuses in a pediatric patient. The post nasal discharge is usually thick mucopurulent that goes onto the oropharyngeal and the laryngeal tissue resulting in frequent throat clearing, and cough which cause mechanical trauma and hoarse voice quality. Previous studies revealed that the voice in individuals presented with chronic sinusitis had lower values in fundamental frequency compared with those that have not sinusitis.

Study Type

Observational

Enrollment (Anticipated)

100

Contacts and Locations

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

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

6 years to 18 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Children aged 6-18 years presented with symptoms of chronic rhinosinusitis will be recruited from the otorhinolaryngology out-patient clinic and department at Assiut University Hospital from October, 2018 to October, 2019.comparing them with children with no symptoms of chronic rhinosinusitis and complaining of vocal symptoms.

Description

Inclusion Criteria:

  • Age: from 6 to 18 years.
  • gender: both sexes will be included.
  • patients with chronic rhinosinusitis according to (European Position Paper on Rhinosinusitis and Nasal Polyps 2012).

Exclusion Criteria:

  • Age below 6 or above 18 years.
  • Children receiving treatment for rhinosinusitis.
  • Previous surgical intervention (laryngeal microsurgery or tracheal intubation).
  • Congenital anomalies.
  • Mental retardation.

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

  • Observational Models: Case-Control
  • Time Perspectives: Retrospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
children with chronic rhinosinusitis
Children aged 6-18 years presented with symptoms of chronic rhinosinusitis will be recruited from the otorhinolaryngology out-patient clinic and department at Assiut University Hospital from October, 2018 to October, 2019.
Computerized Speech Laboratory (model 4300; Kay Elemetrics Corporation)
Other Names:
  • Video rhino- laryngoscope (3.7 mm; 8403 ZXK)
children without chronic rhinosinusitis
Children have the same age and number in the study group which are presented with vocal symptoms and have not chronic rhinosinusitis will be recruited for the same duration.
Computerized Speech Laboratory (model 4300; Kay Elemetrics Corporation)
Other Names:
  • Video rhino- laryngoscope (3.7 mm; 8403 ZXK)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
impact of chronic rhinosinusitis on the laryngeal mucosa and voice quality in children
Time Frame: 20 mimutes
to evaluate effect of rhinosinusitis on acoustic voice parameters by using acoustic voice analysis (model 4300; Kay Elemetrics Corporation) and assessment changes in the laryngeal mucosa using either video rhino- laryngoscope (3.7 mm; 8403 ZXK) orRigid laryngoscope (70 degrees, 8700 CKA).
20 mimutes

Collaborators and Investigators

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

Investigators

  • Principal Investigator: Sahar Sabri Abd-El Raheem, PhD, Assiut university

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.

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 (Anticipated)

October 1, 2018

Primary Completion (Anticipated)

October 1, 2019

Study Completion (Anticipated)

December 1, 2019

Study Registration Dates

First Submitted

October 3, 2018

First Submitted That Met QC Criteria

October 3, 2018

First Posted (Actual)

October 5, 2018

Study Record Updates

Last Update Posted (Actual)

October 5, 2018

Last Update Submitted That Met QC Criteria

October 3, 2018

Last Verified

September 1, 2018

More Information

Terms related to this study

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.

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