DysphoniaNCT03261141
Correlation Between (PV-RQOL), The Auditory Perceptual Assessment and Acoustic Analysis of Voice in Dysphonic Children
An observational study of Dysphonia, run by Assiut University.
Trial summary
The aim of this study is to assess the Correlation between The Arabic Pediatric Voice Related Quality of Life (PV-RQOL), The Auditory Perceptual Assessment and Acoustic Analysis of voice of dysphonic children. This is important to provide an efficient therapeutic strategy for these children. Read more about this study
- Who is it for?
- Ages 6 to 18 years
- Conditions the study is for
- Dysphonia
- What is being tested?
- (PV-RQOL),(APA) ,Acoustic analysis
- How many people
- 126 participants
- Where
- No sites listed yet
- Study dates
- 1 Nov 2017to Oct 2018
- 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
- Child, Adult
Study population: One hundred twenty six (126) children will participate in the study; in 2 groups ,1-study group 63 children they have dysphonia due to functional (non-organic) causes or due to Minimal Associated Pathological Lesions (MAPLs),2-control group 63 children without vocal complaints They will be recruited from the outpatient clinic of Phoniatric Unit, Assiut University Hospital. Participants (whether their caretakers or themselves) will sign an informed consent of approval to participate in the study after explanation of the study procedures.
Who may be able to join
- -clinical diagnosis of change of voice due to functional (non-organic) causes or due to Minimal Associated Pathological Lesions (MAPLs).
Who cannot join
- Mental Retardation.
- chronic illnesses affecting their quality of lives.
- organic voice disorders.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Correlation Between The Arabic Pediatric Voice Related Quality of Life (PV-RQOL), The Auditory Perceptual Assessment and Acoustic Analysis of Voice in Dysphonic Children
The aim of this study is to assess the Correlation between The Arabic Pediatric Voice Related Quality of Life (PV-RQOL), The Auditory Perceptual Assessment and Acoustic Analysis of voice of dysphonic children. This is important to provide an efficient therapeutic strategy for these children.
Read the detailed description
Voice is the carrier wave for speech signal. It can also be defined as an audible sound produced by phonation . It is a primary mean of expression and oral communication and has life-long importance to social well-being.
Through life, voice development follows and represents organic, psychological, and social changes in the person .
Any disruption of the function of voice is called dysphonia . defination of dysphonia is perceptual audible change of a patient's habitual voice as self-judged or judged by his or her listeners.
The incidence of the pediatric voice disorders ranges from 6%-23%, while, stated that voice disorders affect approximately 6-9% of pediatric population. Boys were statistically more likely to have dysphonia (7.5%) over girls (4.6%) , abnormal vocal presentations (symptomatology) include: phonasthenia ,dysphonia, aphonia and dysodia. Dysphonia may adversely impact a child's general health, communicative effectiveness, social and educational development, self-esteem, and participation in school group activities. Hence, dysphonia has a substantial negative effect on children's lives.Although voice disorders are common in the pediatric population; there is still a lack of information available to clinicians regarding evaluation and treatment of pediatric voice disorders.
Etiology of Voice disorders can be subdivided into 3 main groups: There are the organic voice disorders (There are detectable morphological changes in the vocal apparatus), Non-organic (functional) voice disorders (There is no detectable organic pathology in the structure of the larynx) and Minimal Associated Pathological Lesions (MAPLs) (Long-standing, non-organic (functional) voice disorders leading to the creation of detectable organic changes.
The protocol of evaluation of voice disorders is constructed /built in escalating stepwise stages from the simple subjective bed-side diagnostic procedures to the more sophisticated objective quantitative instrumental measures. Thus the protocol encompasses the following 3 levels which are 1- Elementary diagnostic procedures, 2-Clinical diagnostic aids 3-Additional instrumental measures .
Several instruments have been designed specifically to evaluate quality of life outcomes in dysphonic populations. The best validated and most utilized surveys are the Voice Handicap Index (VHI) , the Voice Outcome Survey (VOS) and the Voice-Related Quality of Life (V-RQoL) . These instruments were designed to be used in the assessment of dysphonic patients and were validated in adult populations. Since their dissemination, each of these instruments have produced a pediatric analogue, namely a pediatric VOS (PVOS) , a pediatric V-RQoL and a pediatric VHI (PVHI).
Questionnaire may help to increase the patient's awareness of the impact of dysphonia and his motivation for change. The Questionnaires have also been proven sensitive to post-changes and are an additional and valuable tool in the determination of therapy efficiency.
At Minia University, a study was carried out to develop an Arabic version of PVRQoL and test its validity and reliability .The results suggested that the APVRQoL is a valid and reliable assessment tool that can be used by the parents of Arabic-speaking children or by the children themselves (when they are older) with voice disorders to assess the impact of dysphonia on the quality of their lives.
The (PV-RQOL) has 10 questions that are divided among 4 subdomains: The social (questions no: 8 and 10), emotional (questions no: 4 and 5) , The physical (questions no: 2 and 3) and the functional (questions no: 1, 6,7 and 9), each question is rated from 1to5 (1=no problem and is given"10 points",2=a small amount and is given"7.5points",3=a moderate amount and is given"5 points",4=a lot and is given"2.5 points", and 5=problem is as bad as it can be, and is given"0 points". Thus the raw scores can range from 0 to 100 points with higher scores indicating a better quality of life.
- Conditions
- Dysphonia
- Being tested
- (PV-RQOL),(APA) ,Acoustic analysis
- Medical subject headings
- Dysphonia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
(PV-RQOL),(APA) ,Acoustic analysisCombination product
- severity and character of dysphonia (measured by Auditory Perceptual Assessment using a modified GRBAS scale which gives scores as regard the degree and severity of dysphonia and its character.
- Acoustic Analysis of voice : which is Computerized Speech Laboratory analysis of voice that gives the following measures jitter (%), shimmer (dB), and harmonic to noise ratio (H/N).
- the degree of social ,emotional ,functional and physical disturbance ,if present in those children with voice disorders by application of The Arabic Pediatric Voice Related Quality of Life (PV-RQOL).
| Study group | Role | What they receive |
|---|---|---|
| study group sixty three children | 1. severity and character of dysphonia APA using a modified GRBAS scale which gives scores as regard the degree and severity of dysphonia and its character.
2. Acoustic Analysis of voice : which is Computerized Speech Laboratory analysis of voice that gives the following measures jitter (%), shimmer (dB), and harmonic to noise ratio (H/N).
3. the degree of social ,emotional ,functional and physical disturbance ,if present in those children with voice disorders by application of The Arabic Pediatric Voice Related Quality of Life (PV-RQOL). Receives: Combination Product: (PV-RQOL),(APA) ,Acoustic analysis | |
| control group sixty three children | 1. severity and character of dysphonia (APA using a modified GRBAS scale which gives scores as regard the degree and severity of dysphonia and its character.
2. Acoustic Analysis of voice : which is Computerized Speech Laboratory analysis of voice that gives the following measures jitter (%), shimmer (dB), and harmonic to noise ratio (H/N).
3. the degree of social ,emotional ,functional and physical disturbance ,if present in those children with voice disorders by application of The Arabic Pediatric Voice Related Quality of Life (PV-RQOL). Receives: Combination Product: (PV-RQOL),(APA) ,Acoustic analysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
All participants' scores of (PV-RQOL) questionnaire will be correlated with scores of auditory perceptual assessment and Acoustic voice analysis.
Application of the Arabic Pediatric Voice Related Quality of Life (PV-RQOL): all participants /parents of the participants will be given (PV-RQOL) form that consists of 10 questions divided among 4 subdomains: The social (questions no: 8 and 10), emotional (questions no: 4 and 5) , The physical (questions no: 2 and 3) and the functional (questions no: 1, 6,7 and 9) . Thus the total score can range from 0 to 100 points with higher scores indicating a better quality of life.and Auditory perceptual assessment (APA) of the participant's voice: the domains will be graded on a scale of 0-3, in which 0 is normal and 3 is severe.and Acoustic voice analysis: will be carried out using Kay Elemetrics' Computerized Speech Laboratory. These measures will be obtained by recording the voice of each participant using a microphone positioned ∼10 cm from his/her mouth and the participantswill be asked to phonate a sustained vowel /a/ at comfortable pitch and intensity levels.
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2017
- Study start1 Nov 2017 (estimated)
- Primary completionSep 2018 (estimated)
- Study completionOct 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for DysphoniaStudies 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
- Cross-sectional
- Enrolment
- 126 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Asmaa Fathy, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03261141
- Sponsor's protocol ID
- PV-RQOL in Dysphonic children
- Status last verified
- Aug 2017
- First submitted
- 21 Aug 2017
- Last updated
- 24 Oct 2017
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Lopes LW, Barbosa Lima IL, Alves Almeida LN, Cavalcante DP, de Almeida AA. Severity of voice disorders in children: correlations between perceptual and acoustic data. J Voice. 2012 Nov;26(6):819.e7-12. doi: 10.1016/j.jvoice.2012.05.008.
PubMed 23177753Kotby MN, Shiromoto O, Hirano M. The accent method of voice therapy: effect of accentuations on FO, SPL, and airflow. J Voice. 1993 Dec;7(4):319-25. doi: 10.1016/s0892-1997(05)80120-1.
PubMed 8293064Carding PN, Roulstone S, Northstone K; ALSPAC Study Team. The prevalence of childhood dysphonia: a cross-sectional study. J Voice. 2006 Dec;20(4):623-30. doi: 10.1016/j.jvoice.2005.07.004. Epub 2005 Dec 19.
PubMed 16360302Trani M, Ghidini A, Bergamini G, Presutti L. Voice therapy in pediatric functional dysphonia: a prospective study. Int J Pediatr Otorhinolaryngol. 2007 Mar;71(3):379-84. doi: 10.1016/j.ijporl.2006.11.002. Epub 2006 Nov 29.
PubMed 17137639Blumin JH, Keppel KL, Braun NM, Kerschner JE, Merati AL. The impact of gender and age on voice related quality of life in children: normative data. Int J Pediatr Otorhinolaryngol. 2008 Feb;72(2):229-34. doi: 10.1016/j.ijporl.2007.10.015. Epub 2007 Dec 11.
PubMed 18063123Connor NP, Cohen SB, Theis SM, Thibeault SL, Heatley DG, Bless DM. Attitudes of children with dysphonia. J Voice. 2008 Mar;22(2):197-209. doi: 10.1016/j.jvoice.2006.09.005. Epub 2007 May 18.
PubMed 17512168Gliklich RE, Glovsky RM, Montgomery WW. Validation of a voice outcome survey for unilateral vocal cord paralysis. Otolaryngol Head Neck Surg. 1999 Feb;120(2):153-8. doi: 10.1016/S0194-5998(99)70399-2.
PubMed 9949345Hartnick CJ. Validation of a pediatric voice quality-of-life instrument: the pediatric voice outcome survey. Arch Otolaryngol Head Neck Surg. 2002 Aug;128(8):919-22. doi: 10.1001/archotol.128.8.919.
PubMed 12162771Boseley ME, Cunningham MJ, Volk MS, Hartnick CJ. Validation of the Pediatric Voice-Related Quality-of-Life survey. Arch Otolaryngol Head Neck Surg. 2006 Jul;132(7):717-20. doi: 10.1001/archotol.132.7.717.
PubMed 16847178Zur KB, Cotton S, Kelchner L, Baker S, Weinrich B, Lee L. Pediatric Voice Handicap Index (pVHI): a new tool for evaluating pediatric dysphonia. Int J Pediatr Otorhinolaryngol. 2007 Jan;71(1):77-82. doi: 10.1016/j.ijporl.2006.09.004. Epub 2006 Oct 13.
PubMed 17046072Verduyckt I, Remacle M, Jamart J, Benderitter C, Morsomme D. Voice-related complaints in the pediatric population. J Voice. 2011 May;25(3):373-80. doi: 10.1016/j.jvoice.2009.11.008. Epub 2010 Apr 1.
PubMed 20359863
Study at a glance
From the registry record, last updated by the sponsor on 24 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Correlation Between The Arabic Pediatric Voice Related Quality of Life (PV-RQOL), The Auditory Perceptual Assessment and Acoustic Analysis of Voice in Dysphonic Children
- ClinicalTrials.gov ID
- NCT03261141
- Acronym / sponsor ID
- PV-RQOL in Dysphonic children
- Conditions
- Dysphonia
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 126 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Nov 2017 (estimated)
- Primary completion
- Sep 2018 (estimated)
- Study completion
- Oct 2018 (estimated)
- First posted
- 24 Aug 2017 (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.
The aim of this study is to assess the Correlation between The Arabic Pediatric Voice Related Quality of Life (PV-RQOL), The Auditory Perceptual Assessment and Acoustic Analysis of voice of dysphonic children. This is important to provide an efficient therapeutic strategy for these children.
Detailed description
Voice is the carrier wave for speech signal. It can also be defined as an audible sound produced by phonation . It is a primary mean of expression and oral communication and has life-long importance to social well-being.
Through life, voice development follows and represents organic, psychological, and social changes in the person .
Any disruption of the function of voice is called dysphonia . defination of dysphonia is perceptual audible change of a patient's habitual voice as self-judged or judged by his or her listeners.
The incidence of the pediatric voice disorders ranges from 6%-23%, while, stated that voice disorders affect approximately 6-9% of pediatric population. Boys were statistically more likely to have dysphonia (7.5%) over girls (4.6%) , abnormal vocal presentations (symptomatology) include: phonasthenia ,dysphonia, aphonia and dysodia. Dysphonia may adversely impact a child's general health, communicative effectiveness, social and educational development, self-esteem, and participation in school group activities. Hence, dysphonia has a substantial negative effect on children's lives.Although voice disorders are common in the pediatric population; there is still a lack of information available to clinicians regarding evaluation and treatment of pediatric voice disorders.
Etiology of Voice disorders can be subdivided into 3 main groups: There are the organic voice disorders (There are detectable morphological changes in the vocal apparatus), Non-organic (functional) voice disorders (There is no detectable organic pathology in the structure of the larynx) and Minimal Associated Pathological Lesions (MAPLs) (Long-standing, non-organic (functional) voice disorders leading to the creation of detectable organic changes.
The protocol of evaluation of voice disorders is constructed /built in escalating stepwise stages from the simple subjective bed-side diagnostic procedures to the more sophisticated objective quantitative instrumental measures. Thus the protocol encompasses the following 3 levels which are 1- Elementary diagnostic procedures, 2-Clinical diagnostic aids 3-Additional instrumental measures .
Several instruments have been designed specifically to evaluate quality of life outcomes in dysphonic populations. The best validated and most utilized surveys are the Voice Handicap Index (VHI) , the Voice Outcome Survey (VOS) and the Voice-Related Quality of Life (V-RQoL) . These instruments were designed to be used in the assessment of dysphonic patients and were validated in adult populations. Since their dissemination, each of these instruments have produced a pediatric analogue, namely a pediatric VOS (PVOS) , a pediatric V-RQoL and a pediatric VHI (PVHI).
Questionnaire may help to increase the patient's awareness of the impact of dysphonia and his motivation for change. The Questionnaires have also been proven sensitive to post-changes and are an additional and valuable tool in the determination of therapy efficiency.
At Minia University, a study was carried out to develop an Arabic version of PVRQoL and test its validity and reliability .The results suggested that the APVRQoL is a valid and reliable assessment tool that can be used by the parents of Arabic-speaking children or by the children themselves (when they are older) with voice disorders to assess the impact of dysphonia on the quality of their lives.
The (PV-RQOL) has 10 questions that are divided among 4 subdomains: The social (questions no: 8 and 10), emotional (questions no: 4 and 5) , The physical (questions no: 2 and 3) and the functional (questions no: 1, 6,7 and 9), each question is rated from 1to5 (1=no problem and is given"10 points",2=a small amount and is given"7.5points",3=a moderate amount and is given"5 points",4=a lot and is given"2.5 points", and 5=problem is as bad as it can be, and is given"0 points". Thus the raw scores can range from 0 to 100 points with higher scores indicating a better quality of life.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| study group sixty three children | – | Combination Product: (PV-RQOL),(APA) ,Acoustic analysis1. severity and character of dysphonia APA using a modified GRBAS scale which gives scores as regard the degree and severity of dysphonia and its character. 2. Acoustic Analysis of voice : which is Computerized Speech Laboratory analysis of voice that gives the following measures jitter (%), shimmer (dB), and harmonic to noise ratio (H/N). 3. the degree of social ,emotional ,functional and physical disturbance ,if present in those children with voice disorders by application of The Arabic Pediatric Voice Related Quality of Life (PV-RQOL). |
| control group sixty three children | – | Combination Product: (PV-RQOL),(APA) ,Acoustic analysis1. severity and character of dysphonia (APA using a modified GRBAS scale which gives scores as regard the degree and severity of dysphonia and its character. 2. Acoustic Analysis of voice : which is Computerized Speech Laboratory analysis of voice that gives the following measures jitter (%), shimmer (dB), and harmonic to noise ratio (H/N). 3. the degree of social ,emotional ,functional and physical disturbance ,if present in those children with voice disorders by application of The Arabic Pediatric Voice Related Quality of Life (PV-RQOL). |
Who may qualify
- Ages
- 6 to 18 years
- Sex
- All
- Age groups
- Child, Adult
- Study population
- One hundred twenty six (126) children will participate in the study; in 2 groups ,1-study group 63 children they have dysphonia due to functional (non-organic) causes or due to Minimal Associated Pathological Lesions (MAPLs),2-control group 63 children without vocal complaints They will be recruited from the outpatient clinic of Phoniatric Unit, Assiut University Hospital. Participants (whether their caretakers or themselves) will sign an informed consent of approval to participate in the study after explanation of the study procedures.
Key inclusion criteria (1 listed)
- -clinical diagnosis of change of voice due to functional (non-organic) causes or due to Minimal Associated Pathological Lesions (MAPLs).
Key exclusion criteria (3 listed)
- Mental Retardation.
- chronic illnesses affecting their quality of lives.
- organic voice disorders.
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 |
|---|---|---|
| (PV-RQOL),(APA) ,Acoustic analysis1. severity and character of dysphonia (measured by Auditory Perceptual Assessment using a modified GRBAS scale which gives scores as regard the degree and severity of dysphonia and its character. 2. Acoustic Analysis of voice : which is Computerized Speech Laboratory analysis of voice that gives the following measures jitter (%), shimmer (dB), and harmonic to noise ratio (H/N). 3. the degree of social ,emotional ,functional and physical disturbance ,if present in those children with voice disorders by application of The Arabic Pediatric Voice Related Quality of Life (PV-RQOL). | Combination product | control group sixty three children, study group sixty three children |
Primary outcome
All participants' scores of (PV-RQOL) questionnaire will be correlated with scores of auditory perceptual assessment and Acoustic voice analysis.
Time frame: baseline
Application of the Arabic Pediatric Voice Related Quality of Life (PV-RQOL): all participants /parents of the participants will be given (PV-RQOL) form that consists of 10 questions divided among 4 subdomains: The social (questions no: 8 and 10), emotional (questions no: 4 and 5) , The physical (questions no: 2 and 3) and the functional (questions no: 1, 6,7 and 9) . Thus the total score can range from 0 to 100 points with higher scores indicating a better quality of life.and Auditory perceptual assessment (APA) of the participant's voice: the domains will be graded on a scale of 0-3, in which 0 is normal and 3 is severe.and Acoustic voice analysis: will be carried out using Kay Elemetrics' Computerized Speech Laboratory. These measures will be obtained by recording the voice of each participant using a microphone positioned ∼10 cm from his/her mouth and the participantswill be asked to phonate a sustained vowel /a/ at comfortable pitch and intensity levels.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Oct 2017.
- Background: PubMed 23177753Lopes LW, Barbosa Lima IL, Alves Almeida LN, Cavalcante DP, de Almeida AA. Severity of voice disorders in children: correlations between perceptual and acoustic data. J Voice. 2012 Nov;26(6):819.e7-12. doi: 10.1016/j.jvoice.2012.05.008.
- Background: PubMed 8293064Kotby MN, Shiromoto O, Hirano M. The accent method of voice therapy: effect of accentuations on FO, SPL, and airflow. J Voice. 1993 Dec;7(4):319-25. doi: 10.1016/s0892-1997(05)80120-1.
- Background: PubMed 16360302Carding PN, Roulstone S, Northstone K; ALSPAC Study Team. The prevalence of childhood dysphonia: a cross-sectional study. J Voice. 2006 Dec;20(4):623-30. doi: 10.1016/j.jvoice.2005.07.004. Epub 2005 Dec 19.
- Background: PubMed 17137639Trani M, Ghidini A, Bergamini G, Presutti L. Voice therapy in pediatric functional dysphonia: a prospective study. Int J Pediatr Otorhinolaryngol. 2007 Mar;71(3):379-84. doi: 10.1016/j.ijporl.2006.11.002. Epub 2006 Nov 29.
- Background: PubMed 18063123Blumin JH, Keppel KL, Braun NM, Kerschner JE, Merati AL. The impact of gender and age on voice related quality of life in children: normative data. Int J Pediatr Otorhinolaryngol. 2008 Feb;72(2):229-34. doi: 10.1016/j.ijporl.2007.10.015. Epub 2007 Dec 11.
- Background: PubMed 17512168Connor NP, Cohen SB, Theis SM, Thibeault SL, Heatley DG, Bless DM. Attitudes of children with dysphonia. J Voice. 2008 Mar;22(2):197-209. doi: 10.1016/j.jvoice.2006.09.005. Epub 2007 May 18.
- Background: PubMed 9949345Gliklich RE, Glovsky RM, Montgomery WW. Validation of a voice outcome survey for unilateral vocal cord paralysis. Otolaryngol Head Neck Surg. 1999 Feb;120(2):153-8. doi: 10.1016/S0194-5998(99)70399-2.
- Background: PubMed 12162771Hartnick CJ. Validation of a pediatric voice quality-of-life instrument: the pediatric voice outcome survey. Arch Otolaryngol Head Neck Surg. 2002 Aug;128(8):919-22. doi: 10.1001/archotol.128.8.919.
- Background: PubMed 16847178Boseley ME, Cunningham MJ, Volk MS, Hartnick CJ. Validation of the Pediatric Voice-Related Quality-of-Life survey. Arch Otolaryngol Head Neck Surg. 2006 Jul;132(7):717-20. doi: 10.1001/archotol.132.7.717.
- Background: PubMed 17046072Zur KB, Cotton S, Kelchner L, Baker S, Weinrich B, Lee L. Pediatric Voice Handicap Index (pVHI): a new tool for evaluating pediatric dysphonia. Int J Pediatr Otorhinolaryngol. 2007 Jan;71(1):77-82. doi: 10.1016/j.ijporl.2006.09.004. Epub 2006 Oct 13.
- Background: PubMed 20359863Verduyckt I, Remacle M, Jamart J, Benderitter C, Morsomme D. Voice-related complaints in the pediatric population. J Voice. 2011 May;25(3):373-80. doi: 10.1016/j.jvoice.2009.11.008. Epub 2010 Apr 1.
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Dysphonia, 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 1 inclusion and 3 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 24 Oct 2017. 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 Asmaa Fathy, resident (01149852648, asmaafathy254@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
All participants' scores of (PV-RQOL) questionnaire will be correlated with scores of auditory perceptual assessment and Acoustic voice analysis. (time frame: baseline). 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 NCT03261141, which also lists 11 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 24 Oct 2017.