Voice Disorders in ChildrenNCT03696693
Effect of Chronic Rhinosinusitis on Voice of Children
An observational study of Voice Disorders in Children, run by Assiut University.
Trial 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 Read more about this study
- Who is it for?
- Ages 6 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Voice Disorders in Children
- What is being tested?
- acoustic vocal analysis
- Type of treatment
- Medical device
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- Oct 2018to Dec 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
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.
Who may be able to join
- 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).
Who cannot join
- Age below 6 or above 18 years.
- Children receiving treatment for rhinosinusitis.
- Previous surgical intervention (laryngeal microsurgery or tracheal intubation).
- Congenital anomalies.
- Mental retardation.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: 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
Read the 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.
- Conditions
- Voice Disorders in Children
- Being tested
- acoustic vocal analysis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
acoustic vocal analysisDevice
Also called Video rhino- laryngoscope (3.7 mm; 8403 ZXK)
Computerized Speech Laboratory (model 4300; Kay Elemetrics Corporation)
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Device: acoustic vocal analysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 20 mimutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2018
- Study startOct 2018 (estimated)
- Primary completionOct 2019 (estimated)
- Study completionDec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Voice Disorders in ChildrenStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sahar Sabri Abdelraheem, Assiut University
- Investigators
- Sahar Sabri Abd-El Raheem, PhD, Principal investigator, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03696693
- Sponsor's protocol ID
- rhinosinusitis in children
- Status last verified
- Sep 2018
- First submitted
- 3 Oct 2018
- Last updated
- 5 Oct 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 24427691Dlova 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.
PubMed 26547604Fokkens 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.
PubMed 22764607Cecil 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.
PubMed 11411480
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Chronic Rhinosinusitis on the Laryngeal Mucosa and Voice Quality in Children Aged From 6- to 18- Years Old
- ClinicalTrials.gov ID
- NCT03696693
- Acronym / sponsor ID
- rhinosinusitis in children
- Conditions
- Voice Disorders in Children
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- Oct 2018 (estimated)
- Primary completion
- Oct 2019 (estimated)
- Study completion
- Dec 2019 (estimated)
- First posted
- 5 Oct 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| children with chronic rhinosinusitis | – | Device: acoustic vocal analysisChildren 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 | – | Device: acoustic vocal analysisChildren 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. |
Who may qualify
- Ages
- 6 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- 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.
Key inclusion criteria (3 listed)
- 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).
Key exclusion criteria (5 listed)
- Age below 6 or above 18 years.
- Children receiving treatment for rhinosinusitis.
- Previous surgical intervention (laryngeal microsurgery or tracheal intubation).
- Congenital anomalies.
- Mental retardation.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| acoustic vocal analysisAlso: Video rhino- laryngoscope (3.7 mm; 8403 ZXK)Computerized Speech Laboratory (model 4300; Kay Elemetrics Corporation) | Device | children with chronic rhinosinusitis, children without chronic rhinosinusitis |
Primary outcome
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).
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Oct 2018.
- Results publication: PubMed 24427691Develioglu 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.
- Results publication: PubMed 26547604Dlova 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.
- Results publication: PubMed 22764607Fokkens 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.
- Results publication: PubMed 11411480Cecil 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sahar Sabri Abd-El Raheem, PhD principal investigator
Assiut University
Questions about this trial
What is this clinical trial studying?
An observational study of Voice Disorders in Children, run by Assiut University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Eman Sayed Hassan, professor (01004082014 ext. +20, eshh2003@aun.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
impact of chronic rhinosinusitis on the laryngeal mucosa and voice quality in children (time frame: 20 mimutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03696693, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Oct 2018.