Stuttering, ChildhoodPhase 4NCT05291572
Comparative Study Between Three Different Methods for Stuttering Therapy in Children
A Phase 4 study testing speech therapy only, hyperbaric oxygen therapy and medical treatment in people with Stuttering, Childhood, run by Sohag University.
Trial summary
The aim of work is comparing between three different methods for treatment of stuttering in children in order to reach to the best method for treatment Read more about this study
- Who is it for?
- Ages 5 to 15 years
- Conditions the study is for
- Stuttering, Childhood
- What is being tested?
- speech therapy only, hyperbaric oxygen therapy and medical treatment
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- Apr 2022to Oct 2023
- Phase
- Phase 4
- 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 5 to 15 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children from 5 to 15 years old with IQ above 80
Who cannot join
- 1 - mental disability. 2- psychiatric problem as autism or attention deficit hyperactive disease. 3. secondary stuttering. 4. Children with sever anxiety. 5. Children with history suggested epileptic fits.
Trial locations and contacts
No sites are listed yet.
About this study
The aim of work is comparing between three different methods for treatment of stuttering in children in order to reach to the best method for treatment
- Conditions
- Stuttering, Childhood
- Being tested
- speech therapy only, hyperbaric oxygen therapy, medical treatment
- Medical subject headings
- Stuttering
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
speech therapy onlyBehavioural
fluency shaping technique
hyperbaric oxygen therapyDevice
chamber system using oxygen with pressure
medical treatmentDrug
brain stimulant
| Study group | Role | What they receive |
|---|---|---|
| Group A | Active comparator | will be treated by speech therapy only (fluency shaping). Receives: Behavioral: speech therapy only |
| Group B | Active comparator | will be treated by speech therapy (fluency shaping) plus Hyperbaric oxygen therapy. Receives: Behavioral: speech therapy only; Device: hyperbaric oxygen therapy |
| Group C | Active comparator | will be treated by speech therapy (fluency shaping) plus medical treatment (brain stimulant). Receives: Behavioral: speech therapy only; Drug: medical treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Stuttering severity instrument (SSI-3)
rating scale for stuttering severity
Measured: before therapy
Secondary outcomes (1)
Stuttering severity instrument (SSI-3)
rating scale for stuttering severity
Measured: post therapy by 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2022
- Study startApr 2022 (estimated)
- Primary completionApr 2023 (estimated)
- Study completionOct 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stuttering, ChildhoodStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alzahraa Momen Abdelnaeem, Sohag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05291572
- Sponsor's protocol ID
- Soh-Med-22-03-02
- Status last verified
- Mar 2022
- First submitted
- 12 Mar 2022
- Last updated
- 22 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Study Between Three Different Methods for Stuttering Therapy in Children
- ClinicalTrials.gov ID
- NCT05291572
- Acronym / sponsor ID
- Soh-Med-22-03-02
- Conditions
- Stuttering, Childhood
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- Apr 2022 (estimated)
- Primary completion
- Apr 2023 (estimated)
- Study completion
- Oct 2023 (estimated)
- First posted
- 22 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.
The aim of work is comparing between three different methods for treatment of stuttering in children in order to reach to the best method for treatment
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group A | Active comparator | Behavioral: speech therapy onlywill be treated by speech therapy only (fluency shaping). |
| Group B | Active comparator | Behavioral: speech therapy only, Device: hyperbaric oxygen therapywill be treated by speech therapy (fluency shaping) plus Hyperbaric oxygen therapy. |
| Group C | Active comparator | Behavioral: speech therapy only, Drug: medical treatmentwill be treated by speech therapy (fluency shaping) plus medical treatment (brain stimulant). |
Who may qualify
- Ages
- 5 to 15 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Children from 5 to 15 years old with IQ above 80
Key exclusion criteria (1 listed)
- 1 - mental disability. 2- psychiatric problem as autism or attention deficit hyperactive disease. 3. secondary stuttering. 4. Children with sever anxiety. 5. Children with history suggested epileptic fits.
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 |
|---|---|---|
| speech therapy onlyfluency shaping technique | Behavioural | Group A, Group B, Group C |
| hyperbaric oxygen therapychamber system using oxygen with pressure | Device | Group B |
| medical treatmentbrain stimulant | Drug | Group C |
Primary outcome
Stuttering severity instrument (SSI-3)
Time frame: before therapy
rating scale for stuttering severity
1 secondary outcome
Stuttering severity instrument (SSI-3)
Time frame: post therapy by 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Mar 2022.
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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?
A Phase 4 study testing speech therapy only, hyperbaric oxygen therapy and medical treatment in people with Stuttering, Childhood, run by Sohag 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 1 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 22 Mar 2022. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 el-zahraa moemen Abdel Naeem (01066177366, elzahraa.tawfeek@med.sohag.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Stuttering severity instrument (SSI-3) (time frame: before therapy). 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 22 Mar 2022.