ClinicalTrials.gg
RecruitingNCT06856785Updated Mar 4, 2025

Management of Non-Organic Dysphonia in Adults.

An interventional study of Resonance Tube Voice Therapy in Water in Functional Dysphonia, Resonance Tube Voice Therapy and Smith Accent Method Therapy, sponsored by Sohag University. Recruiting at 1 site in Egypt. Open to participants aged 15 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-03-04.

Sponsored by Sohag University · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Aug 2025, 1 year 3 months ago, but the record still lists the study as recruiting.
Phase
Not applicable
Study type
Interventional
Enrollment
60
Allocation
Randomized
Ages
15 Years to 60 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Functional Dysphonia
  • Resonance Tube Voice Therapy
  • Smith Accent Method Therapy

Browse trials for

03

In context

Dysphonia

132 studies on the registry are indexed under Dysphonia; 38 are open to participants now.

This study's planned enrollment of 60 is above the median of 30 across 87 interventional studies indexed under Dysphonia.

Browse Dysphonia 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
15 Years to 60 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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

  • 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.

Exclusion criteria

Exclusion Criteria:

  • 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.
  • Cigarette smoking, alcohol, or drug abuse for the past 5 years.
  • Patients with previous micro laryngeal surgery.
  • Patients with gastrointestinal reflux disease.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
60 participants (estimated)

Study arms

  • No intervention
    Non-organic (Functional) dysphonia patients will receive Smith Accent Voice Therapy

    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)

  • Active comparator
    Non-organic (Functional) dysphonia patients will receive Resonance Tube Voice Therapy

    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.

    Other: Resonance Tube Voice Therapy in Water

Interventions

  • OtherResonance Tube Voice Therapy in Water

    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

    Also known as: Smith Accent Voice Exercises

06

What researchers measure

Primary outcomes

  1. 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).

    Time frame: 12 weeks following end of the treatment

07

Study locations

1 of 1 sites recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 4, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06856785
Lead sponsor
Sohag University
Responsible party
Shereen Mohamed Hamed (Phoniatric Resisdent Physician, Sohag University) — Principal investigator
First posted
Mar 4, 2025
Start date
Mar 2025 (estimated)
Primary completion
Aug 2025 (estimated)
Completion
Sep 2025 (estimated)
Last update
Mar 4, 2025

Study contacts

Shereen Hamed, Resident Physician
Contact
shereen.mohammad@med.sohag.edu.eg
+201120645166

Oversight

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

Interested in this study?

Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.

Contact study team

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion