NCT03696693

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

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Oct 2018

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2018

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

October 3, 2018

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 5, 2018

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2019

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2019

Completed
Last Updated

October 5, 2018

Status Verified

September 1, 2018

Enrollment Period

1 year

First QC Date

October 3, 2018

Last Update Submit

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.

Device: acoustic vocal analysis

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.

Device: acoustic vocal analysis

Interventions

Computerized Speech Laboratory (model 4300; Kay Elemetrics Corporation)

Also known as: Video rhino- laryngoscope (3.7 mm; 8403 ZXK)
children with chronic rhinosinusitischildren without chronic rhinosinusitis

Eligibility Criteria

Age6 Years - 18 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-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.

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.

  • Dlova 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.

  • Fokkens 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.

  • Cecil 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.

Study Officials

  • Sahar Sabri Abd-El Raheem, PhD

    Assiut University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Eman Sayed Hassan, professor

CONTACT

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