Effect of Chronic Rhinosinusitis on Voice of Children
Impact of Chronic Rhinosinusitis on the Laryngeal Mucosa and Voice Quality in Children Aged From 6- to 18- Years Old
1 other identifier
observational
100
0 countries
N/A
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Oct 2018
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2018
CompletedFirst Submitted
Initial submission to the registry
October 3, 2018
CompletedFirst Posted
Study publicly available on registry
October 5, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2019
CompletedOctober 5, 2018
September 1, 2018
1 year
October 3, 2018
October 3, 2018
Conditions
Outcome Measures
Primary Outcomes (1)
impact of chronic rhinosinusitis on the laryngeal mucosa and voice quality in children
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
Study Arms (2)
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.
Interventions
Computerized Speech Laboratory (model 4300; Kay Elemetrics Corporation)
Eligibility Criteria
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.
You may qualify if:
- 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).
You may not qualify if:
- Age below 6 or above 18 years.
- Children receiving treatment for rhinosinusitis.
- Previous surgical intervention (laryngeal microsurgery or tracheal intubation).
- Congenital anomalies.
- Mental retardation.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Publications (4)
Develioglu ON, Paltura C, Koleli H, Kulekci M. The effect of medical treatment on voice quality in allergic rhinitis. Indian J Otolaryngol Head Neck Surg. 2013 Aug;65(Suppl 2):426-30. doi: 10.1007/s12070-013-0639-5. Epub 2013 Mar 14.
PMID: 24427691RESULTDlova NC, Fabbrocini G, Lauro C, Spano M, Tosti A, Hift RH. Quality of life in South African Black women with alopecia: a pilot study. Int J Dermatol. 2016 Aug;55(8):875-81. doi: 10.1111/ijd.13042. Epub 2015 Nov 6.
PMID: 26547604RESULTFokkens WJ, Lund VJ, Mullol J, Bachert C, Alobid I, Baroody F, Cohen N, Cervin A, Douglas R, Gevaert P, Georgalas C, Goossens H, Harvey R, Hellings P, Hopkins C, Jones N, Joos G, Kalogjera L, Kern B, Kowalski M, Price D, Riechelmann H, Schlosser R, Senior B, Thomas M, Toskala E, Voegels R, Wang de Y, Wormald PJ. European Position Paper on Rhinosinusitis and Nasal Polyps 2012. Rhinol Suppl. 2012 Mar;23:3 p preceding table of contents, 1-298.
PMID: 22764607RESULTCecil M, Tindall L, Haydon R. The relationship between dysphonia and sinusitis: a pilot study. J Voice. 2001 Jun;15(2):270-7. doi: 10.1016/S0892-1997(01)00027-3.
PMID: 11411480RESULT
Study Officials
- PRINCIPAL INVESTIGATOR
Sahar Sabri Abd-El Raheem, PhD
Assiut University
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- principal investigator
Study Record Dates
First Submitted
October 3, 2018
First Posted
October 5, 2018
Study Start
October 1, 2018
Primary Completion
October 1, 2019
Study Completion
December 1, 2019
Last Updated
October 5, 2018
Record last verified: 2018-09