DysphoniaNCT05264961
Behavioral Abnormalities in Dysphonic Children
A study testing voice therapy in people with Dysphonia, run by Sohag University at 1 site in Egypt.
Trial summary
we will assess dysphonic children as regard presence of behavioral abnormalities and then receive voice therapy Read more about this study
- Who is it for?
- Ages 6 to 12 years
- Conditions the study is for
- Dysphonia
- What is being tested?
- voice therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Mar 2022to Dec 2024
- Phase
- Interventional
- 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 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- dysphonic children age 6-12 years
Who cannot join
- age less than 6 years and more than 12 years,
- hearing impaired,
- neurological abnormalities.
Trial locations and contacts
1 site in 1 country.
About this study
we will assess dysphonic children as regard presence of behavioral abnormalities and then receive voice therapy
- Conditions
- Dysphonia
- Being tested
- voice therapy
- Medical subject headings
- Dysphonia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
voice therapyBehavioural
sessions of voice therapy
| Study group | Role | What they receive |
|---|---|---|
| control group | Other | dysphonic children without behavioral abnormalities Receives: Behavioral: voice therapy |
| study group | Other | dysphonic children with behavioral abnormalities Receives: Behavioral: voice therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
change in child behavior checklist
scale assessing behavioral abnormalities of child as anxiety symptoms,depression symptoms,somatic symptoms,social problems,thought problems,attention problems,aggressive behavior and rule breaking behavior through asking parent of the child with minimal score 24 maximal score 100
Measured: Baseline (before sessions) and after 3 months of sessions
computerized speech lab.
voice sample will be taken from child including vowels and connecting speech will be analyzed by computerized speech lab to evaluate change in acoustic parameters as jitter,shimmer,fundamental frequency and noise to harmonic ratio
Measured: Baseline (before sessions) and after 3 months of sessions
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2022
- Study start1 Mar 2022
- Primary completionNov 2024 (estimated)
- Study completionDec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DysphoniaStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gerges Wasfy Gerges, Sohag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05264961
- Sponsor's protocol ID
- 01011747046
- Status last verified
- Jan 2024
- First submitted
- 8 Feb 2022
- Last updated
- 31 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Behavioral Abnormalities in Dysphonic Children
- ClinicalTrials.gov ID
- NCT05264961
- Acronym / sponsor ID
- 01011747046
- Conditions
- Dysphonia
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- 1 Mar 2022 (actual)
- Primary completion
- Nov 2024 (estimated)
- Study completion
- Dec 2024 (estimated)
- First posted
- 3 Mar 2022 (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.
we will assess dysphonic children as regard presence of behavioral abnormalities and then receive voice therapy
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| control group | Other | Behavioral: voice therapydysphonic children without behavioral abnormalities |
| study group | Other | Behavioral: voice therapydysphonic children with behavioral abnormalities |
Who may qualify
- Ages
- 6 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- dysphonic children age 6-12 years
Key exclusion criteria (3 listed)
- age less than 6 years and more than 12 years,
- hearing impaired,
- neurological abnormalities.
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 |
|---|---|---|
| voice therapysessions of voice therapy | Behavioural | control group, study group |
Primary outcome
change in child behavior checklist
Time frame: Baseline (before sessions) and after 3 months of sessions
scale assessing behavioral abnormalities of child as anxiety symptoms,depression symptoms,somatic symptoms,social problems,thought problems,attention problems,aggressive behavior and rule breaking behavior through asking parent of the child with minimal score 24 maximal score 100
computerized speech lab.
Time frame: Baseline (before sessions) and after 3 months of sessions
voice sample will be taken from child including vowels and connecting speech will be analyzed by computerized speech lab to evaluate change in acoustic parameters as jitter,shimmer,fundamental frequency and noise to harmonic ratio
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jan 2024.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing voice therapy in people with Dysphonia, run by Sohag University at 1 site in Egypt.
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 31 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
change in child behavior checklist (time frame: Baseline (before sessions) and after 3 months of sessions). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 31 Jan 2024.