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Status unknownNCT05291572Updated Mar 22, 2022

Comparative Study Between Three Different Methods for Stuttering Therapy in Children

A Phase 4 interventional study of speech therapy only and hyperbaric oxygen therapy in Stuttering, Childhood, sponsored by Sohag University. Status unknown. Open to participants aged 5 Years to 15 Years. Per ClinicalTrials.gov, last updated 2022-03-22.

Sponsored by Sohag University · Phase 4, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Mar 2022), so the status shown — last known as Not yet recruiting — may be out of date.
Phase
Phase 4
Study type
Interventional
Enrollment
30
Allocation
Randomized
Ages
5 Years to 15 Years
Sex
All
01

Study 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

02

Conditions studied

  • Stuttering, Childhood

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03

In context

Stuttering

74 studies on the registry are indexed under Stuttering; 23 are open to participants now.

This study's planned enrollment of 30 is below the median of 44 across 57 interventional studies indexed under Stuttering.

Browse Stuttering studies →

Lead sponsor

Sohag University is the lead sponsor of 1,230 studies on the registry; 636 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
5 Years to 15 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Children from 5 to 15 years old with IQ above 80

Exclusion criteria

Exclusion Criteria:

  • 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.
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
30 participants (estimated)

Study arms

  • Active comparator
    Group A

    will be treated by speech therapy only (fluency shaping).

    Behavioral: speech therapy only

  • Active comparator
    Group B

    will be treated by speech therapy (fluency shaping) plus Hyperbaric oxygen therapy.

    Behavioral: speech therapy only · Device: hyperbaric oxygen therapy

  • Active comparator
    Group C

    will be treated by speech therapy (fluency shaping) plus medical treatment (brain stimulant).

    Behavioral: speech therapy only · Drug: medical treatment

Interventions

  • Behavioralspeech therapy only

    fluency shaping technique

  • Devicehyperbaric oxygen therapy

    chamber system using oxygen with pressure

  • Drugmedical treatment

    brain stimulant

06

What researchers measure

Primary outcomes

  1. Stuttering severity instrument (SSI-3)

    rating scale for stuttering severity

    Time frame: before therapy

Secondary outcomes

  1. Stuttering severity instrument (SSI-3)

    rating scale for stuttering severity

    Time frame: post therapy by 3 months

07

Study locations

No study locations are listed for this record.

08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 22, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT05291572
Lead sponsor
Sohag University
Responsible party
Alzahraa Momen Abdelnaeem (assistant lecturer, Sohag University) — Principal investigator
First posted
Mar 22, 2022
Start date
Apr 2022 (estimated)
Primary completion
Apr 2023 (estimated)
Completion
Oct 2023 (estimated)
Last update
Mar 22, 2022

Study contacts

el-zahraa moemen Abdel Naeem
Contact
elzahraa.tawfeek@med.sohag.edu.eg
01066177366
ahlam abdel-salam Nabieh
Contact
ahlaamaa@yahoo.com
01001141615

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Mar 2022. You cannot join it, but the record below documents what was studied.

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