Effect of Chronic Rhinosinusitis on Voice of Children

Sponsor:

Collaborators:

Information provided by (Responsible Party):

Sahar Sabri Abdelraheem，Assiut University

Tracking Information

First Submitted Date ^ICMJE

October 3, 2018

First Posted Date ^ICMJE

October 5, 2018

Last Update Posted Date

October 5, 2018

Actual Study Start Date ^ICMJE

October 2018

Estimated Primary Completion Date

October 2019 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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).

Original Primary Outcome Measures ^ICMJE

Same as current

Current Secondary Outcome Measures ^ICMJE

[ Time Frame: ]

Descriptive Information

Brief Title ^ICMJE

Effect of Chronic Rhinosinusitis on Voice of Children

Official Title ^ICMJE

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

Brief Summary

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

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 ^ICMJE

Observational

Study Phase

Study Design ^ICMJE

Allocation:
Intervention Model:
Intervention Model Description:
Masking: Observational
Masking Description:
Primary Purpose:

Condition ^ICMJE

Intervention ^ICMJE

Device: acoustic vocal analysis
Computerized Speech Laboratory (model 4300; Kay Elemetrics Corporation)

Study Arms

: 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.
: 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.

Recruitment Information

Recruitment Status ^ICMJE

Not yet recruiting

Estimated Enrollment ^ICMJE

100

Original Estimated Enrollment ^ICMJE

Same as current

Estimated Study Completion Date

December 2019

Estimated Primary Completion Date

October 2019 (Final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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.

Sex/Gender

Sexes Eligible for Study:

All

Ages

6 Years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Listed Location Countries ^ICMJE

Removed Location Countries

Administrative Information

Has Data Monitoring Committee

U.S. FDA-regulated Product

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

Plan to Share IPD:

Responsible Party

Sahar Sabri Abdelraheem，Assiut University

Study Sponsor ^ICMJE

Assiut University

Collaborators ^ICMJE

Investigators ^ICMJE

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

PRS Account

Assiut University

Verification Date

September 2018

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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