Functional DysphoniaNCT06856785
Management of Non-Organic Dysphonia in Adults.
A study testing Resonance Tube Voice Therapy in Water in people with Functional Dysphonia and Resonance Tube Voice Therapy, run by Sohag University at 1 site in Egypt.
Trial summary
The purpose of this study is to determine the effect of a semi-occluded vocal tract training program, "Resonant Tube Therapy," versus the "Traditional Smith-accent Method" on the quality of voice in patients with Non-Organic "Functional" dysphonia. Read more about this study
- Who is it for?
- Ages 15 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Functional Dysphonia, Resonance Tube Voice Therapy, Smith Accent Method Therapy
- What is being tested?
- Resonance Tube Voice Therapy in Water
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- Mar 2025to Sep 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 15 to 60 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Patients diagnosed with non-organic functional dysphonia with or without Minimally Associated Pathological lesions and referred for voice therapy. The diagnosis was based on the results of the routine clinical assessment of cases of voice disorders by a phoniatrician in the voice clinic.
- Patients 'ages between 15 - 60 years old.
- Native speakers of Arabic.
- Language comprehension adequate for the task.
Who cannot join
- Patients with organic voice disorders.
- Patients with aphonia or Phon asthenia.
- Females within the week of their menstrual cycle or menstruating at the time of data collection to control for the possible hormonal effects or premenstrual water retention on voice quality.
- History of severe respiratory allergies, thyroid pathologies, neuro-motor impairment, hearing impairment, psychiatric problems and physically limiting diseases that might interfere with study completion.
- Those on any regular medication that might affect voice quality.
- Speech disorders.
Show all 9Show fewer
- Cigarette smoking, alcohol, or drug abuse for the past 5 years.
- Patients with previous micro laryngeal surgery.
- Patients with gastrointestinal reflux disease.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site, 1 recruiting
- Recruiting
Faculty of Medicine Sohag University
Sohag
Ahmad Mamdouh, Professor, +201097914755, doc.m.h111992@gmail.com
About this study
Official title: Resonance Tube Voice Therapy Versus Smith Accent Therapy in The Management of Non-Organic Dysphonia in Adults
The purpose of this study is to determine the effect of a semi-occluded vocal tract training program, "Resonant Tube Therapy," versus the "Traditional Smith-accent Method" on the quality of voice in patients with Non-Organic "Functional" dysphonia.
- Being tested
- Resonance Tube Voice Therapy in Water
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Resonance Tube Voice Therapy in WaterOther
Also called Smith Accent Voice Exercises
Resonance Tube of 28 cm in length and 9 mm diameter for adults will be submerged into a bowl of water .Both flexible soft walled tubes,glass tubes or straws can be used
| Study group | Role | What they receive |
|---|---|---|
| Non-organic (Functional) dysphonia patients will receive Smith Accent Voice Therapy | No intervention | The patient was advised to vocal hygiene and to correct the faulty vocal technique by a-diaphragmatic breathing in the sitting position by Using the newly acquired diaphragmatic breathing, the patient is allowed to "sing" the various vowels (/a/, /i/, and /u/), "the largo with one accentuation, the andante with three accentuations, and the fastest, allegro, with five accentuations". b-Body and arm movements during dynamic vowel exercises. Transfer and carry over to connected speech by (the gradual stage-wise transformation from vowel play to connected speech, repeating short phrases after the therapist, reading short phrases with pauses, monologue with short phrases with suitable pauses, dialogue, applying the same pattern) |
| Non-organic (Functional) dysphonia patients will receive Resonance Tube Voice Therapy | Active comparator | The patient sits comfortably with their back straight, holding the tube between their thumb and index fingers, maintaining 1 mm between their teeth, and ensuring no air leak between their lips and the tube. A 1-liter wide plastic container is used, filled with water, with the free end of the tube submerged 2 cm below the water's surface. The patient is instructed to take enough time to relax their respiratory muscles and phonate into the tube to create air bubbles on the water's surface, starting with monotonous words and progressing to different intonations. There are 2-minute rest periods between exercises, and the patient should drink water to prevent dryness. Sessions occur in the clinic until the patient can perform the exercises independently without effort, after which the pathologist may allow practice at home. The patient receives written instructions to practice 10 times daily for 2 minutes each, with 1 hour between practices for 6 weeks. Receives: Other: Resonance Tube Voice Therapy in Water |
What is being measured
The primary outcome is the main question the study is designed to answer.
Voice quality improvement in functional (non-organic) dysphonia adult patients
Patient evaluation will be conducted before and after the voice therapy sessions for the two groups by Voice Handicap Index (VHI).
Measured: 12 weeks following end of the treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2025
- Study startMar 2025 (estimated)
- Primary completionAug 2025 (estimated)
- Study completionSep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Functional DysphoniaStudies of the same condition, open and under way.
- More trials run by Sohag 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shereen Mohamed Hamed, Sohag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06856785
- Sponsor's protocol ID
- Soh-Med--25-2-02MS
- Status last verified
- Mar 2025
- First submitted
- 23 Feb 2025
- Last updated
- 4 Mar 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Resonance Tube Voice Therapy Versus Smith Accent Therapy in The Management of Non-Organic Dysphonia in Adults
- ClinicalTrials.gov ID
- NCT06856785
- Acronym / sponsor ID
- Soh-Med--25-2-02MS
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- Mar 2025 (estimated)
- Primary completion
- Aug 2025 (estimated)
- Study completion
- Sep 2025 (estimated)
- First posted
- 4 Mar 2025 (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 purpose of this study is to determine the effect of a semi-occluded vocal tract training program, "Resonant Tube Therapy," versus the "Traditional Smith-accent Method" on the quality of voice in patients with Non-Organic "Functional" dysphonia.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Non-organic (Functional) dysphonia patients will receive Smith Accent Voice Therapy | No intervention | –The patient was advised to vocal hygiene and to correct the faulty vocal technique by a-diaphragmatic breathing in the sitting position by Using the newly acquired diaphragmatic breathing, the patient is allowed to "sing" the various vowels (/a/, /i/, and /u/), "the largo with one accentuation, the andante with three accentuations, and the fastest, allegro, with five accentuations". b-Body and arm movements during dynamic vowel exercises. Transfer and carry over to connected speech by (the gradual stage-wise transformation from vowel play to connected speech, repeating short phrases after the therapist, reading short phrases with pauses, monologue with short phrases with suitable pauses, dialogue, applying the same pattern) |
| Non-organic (Functional) dysphonia patients will receive Resonance Tube Voice Therapy | Active comparator | Other: Resonance Tube Voice Therapy in WaterThe patient sits comfortably with their back straight, holding the tube between their thumb and index fingers, maintaining 1 mm between their teeth, and ensuring no air leak between their lips and the tube. A 1-liter wide plastic container is used, filled with water, with the free end of the tube submerged 2 cm below the water's surface. The patient is instructed to take enough time to relax their respiratory muscles and phonate into the tube to create air bubbles on the water's surface, starting with monotonous words and progressing to different intonations. There are 2-minute rest periods between exercises, and the patient should drink water to prevent dryness. Sessions occur in the clinic until the patient can perform the exercises independently without effort, after which the pathologist may allow practice at home. The patient receives written instructions to practice 10 times daily for 2 minutes each, with 1 hour between practices for 6 weeks. |
Who may qualify
- Ages
- 15 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- Patients diagnosed with non-organic functional dysphonia with or without Minimally Associated Pathological lesions and referred for voice therapy. The diagnosis was based on the results of the routine clinical assessment of cases of voice disorders by a phoniatrician in the voice clinic.
- Patients 'ages between 15 - 60 years old.
- Native speakers of Arabic.
- Language comprehension adequate for the task.
Key exclusion criteria (9 listed)
- Patients with organic voice disorders.
- Patients with aphonia or Phon asthenia.
- Females within the week of their menstrual cycle or menstruating at the time of data collection to control for the possible hormonal effects or premenstrual water retention on voice quality.
- History of severe respiratory allergies, thyroid pathologies, neuro-motor impairment, hearing impairment, psychiatric problems and physically limiting diseases that might interfere with study completion.
- Those on any regular medication that might affect voice quality.
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 |
|---|---|---|
| Resonance Tube Voice Therapy in WaterAlso: Smith Accent Voice ExercisesResonance Tube of 28 cm in length and 9 mm diameter for adults will be submerged into a bowl of water .Both flexible soft walled tubes,glass tubes or straws can be used | Other | Non-organic (Functional) dysphonia patients will receive Resonance Tube Voice Therapy |
Primary outcome
Voice quality improvement in functional (non-organic) dysphonia adult patients
Time frame: 12 weeks following end of the treatment
Patient evaluation will be conducted before and after the voice therapy sessions for the two groups by Voice Handicap Index (VHI).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2025.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Resonance Tube Voice Therapy in Water in people with Functional Dysphonia and Resonance Tube Voice Therapy, 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 4 inclusion and 9 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: looking for participants now, as of the sponsor's last update on 4 Mar 2025. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Shereen Hamed, Resident Physician (+201120645166, shereen.mohammad@med.sohag.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Voice quality improvement in functional (non-organic) dysphonia adult patients (time frame: 12 weeks following end of the treatment). 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 4 Mar 2025.