NCT06856785

Brief 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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 23, 2025

Completed
6 days until next milestone

Study Start

First participant enrolled

March 1, 2025

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 4, 2025

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2025

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2025

Completed
Last Updated

March 4, 2025

Status Verified

March 1, 2025

Enrollment Period

5 months

First QC Date

February 23, 2025

Last Update Submit

March 2, 2025

Conditions

Outcome Measures

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).

    12 weeks following end of the treatment

Study Arms (2)

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.

Other: Resonance Tube Voice Therapy in Water

Interventions

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

Eligibility Criteria

Age15 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Medicine Sohag University

Sohag, Egypt

RECRUITING

MeSH Terms

Interventions

Water

Intervention Hierarchy (Ancestors)

HydroxidesAlkaliesInorganic ChemicalsAnionsIonsElectrolytesOxidesOxygen Compounds

Central Study Contacts

Shereen Hamed, Resident Physician

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Phoniatric Resisdent Physician

Study Record Dates

First Submitted

February 23, 2025

First Posted

March 4, 2025

Study Start

March 1, 2025

Primary Completion

August 1, 2025

Study Completion

September 1, 2025

Last Updated

March 4, 2025

Record last verified: 2025-03

Data Sharing

IPD Sharing
Will not share

Locations