Clinical trial NCT06960772: Efficacy of Flow Ball Phonation in Professional Voice Users
Official title: Efficacy of Flow Ball Phonation in Professional Voice Users
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Prevention of Voice Disorders in Professional Voice Users
Treatment of Functional Voice Disorders in Professional Voice Users
Keywords: Flow Ball
SOVTE
professional voice users
Straw Phonation
Lead sponsor: University Ghent
Sponsor class: OTHER
First posted: 2025-05-07
Enrollment: 144
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of this study is to investigate the effects of flow ball phonation on the voice of professional voice users and elite vocal performers, both with and without functional voice disorders. Given the substantial vocal demands inherent to this population and their reliance on the voice for occupational purposes, this intervention may represent a valuable approach for the prevention and/or treatment voice disorders.

Detailed description: Background. Due to the high vocal demands, professional voice users (e.g. teachers) and elite vocal performers (e.g. singers) are risk populations for developing voice disorders. High-quality voice research in these vulnerable populations is highly needed for effective and efficient treatment and prevention of voice disorders. The flow ball (FB) is a promising innovative voice therapy device to perform semi-occluded vocal tract exercises (SOVTE) with the extra advantage of providing real-time visual feedback of the airflow. Despite this important advantage, strong efficacy studies of an FB intervention program are lacking.

Objective. To investigate the immediate-, short- and long-term effects of an SOVTE intervention with the FB on the phonation of professional voice users with (treatment) and without (prevention) voice disorders and to compare it with the 'treatment as usual' straw phonation (SP) and a sham condition, using a longitudinal randomized sham-controlled trial (RCT).

Methods. Subjects will be randomly assigned into an FB group, an SP group or a control (sham) group. They will receive a short-term intensive voice intervention of 3 weeks, combining both guided therapy/training sessions and independent practice at home. A flexible strobovideolaryngoscopy and a multidimensional voice assessment will be performed by assessors blinded to group allocation and study phase. Assessments will be performed two times before the intervention (pre 1 and pre 2), immediately after the intensive intervention (post 1) and at 3 weeks (follow-up 1) and 3 months (follow-up 2) follow-up. The sham group will use the same FB device but no phonation will be involved.

Eligibility criteria: OBJECTIVE 1: TREATMENT

Inclusion Criteria:

* All genders
* All ethnicities
* 18 - 60 years
* Diagnosis of a functional voice disorder
* Professional voice users

Exclusion Criteria:

* Diagnosis of an organic voice disorder
* Current participation in voice therapy
* Previous phonosurgical interventions
* Pregnancy
* Smoking
* Nasal or ear diseases
* Neurological disorders

OBJECTIVE 2: PREVENTION

Inclusion Criteria:

* All genders
* All ethnicities
* 18 - 60 years
* Professional voice users

Exclusion Criteria:

* Current or previous diagnosis of a voice disorder
* Current or previous participation in voice therapy
* Previous phonosurgical interventions
* Pregnancy
* Smoking
* Nasal or ear diseases
* Neurological disorders

Primary outcomes:
measure: Flexible Strobovideolaryngoscopy
timeFrame: baseline (before the intervention) and 3 weeks (immediately after the intervention)
measure: Dysphonia Severity Index (DSI)
timeFrame: baseline (twice before the intervention), 3 weeks (immediately after the intervention), 3 weeks follow-up, 3 months follow-up
measure: Acoustic Voice Quality Index (AVQI)
timeFrame: baseline (twice before the intervention), 3 weeks (immediately after the intervention), 3 weeks follow-up, 3 months follow-up
measure: Consensus Auditory-Perceptual Evaluation of Voice (CAPE-V)
timeFrame: baseline (twice before the intervention), 3 weeks (immediately after the intervention), 3 weeks follow-up, 3 months follow-up
measure: Voice Handicap Index
timeFrame: baseline (twice before the intervention), 3 weeks (immediately after the intervention), 3 weeks follow-up, 3 months follow-up
Secondary outcomes:
measure: Maximum phonation time (MPT)
timeFrame: baseline (twice before the intervention), 3 weeks (immediately after the intervention), 3 weeks follow-up, 3 months follow-up
measure: Fundamental frequency (fo)
timeFrame: baseline (twice before the intervention), 3 weeks (immediately after the intervention), 3 weeks follow-up, 3 months follow-up
measure: Jitter
timeFrame: baseline (twice before the intervention), 3 weeks (immediately after the intervention), 3 weeks follow-up, 3 months follow-up
measure: Shimmer
timeFrame: baseline (twice before the intervention), 3 weeks (immediately after the intervention), 3 weeks follow-up, 3 months follow-up
measure: Noise to Harmonics Ratio (NHR)
timeFrame: baseline (twice before the intervention), 3 weeks (immediately after the intervention), 3 weeks follow-up, 3 months follow-up
measure: Voice Range Profile (VRP)
timeFrame: baseline (twice before the intervention), 3 weeks (immediately after the intervention), 3 weeks follow-up, 3 months follow-up
measure: Vocal Tract Discomfort Scale (VTDS)
timeFrame: baseline (twice before the intervention), 3 weeks (immediately after the intervention), 3 weeks follow-up, 3 months follow-up
measure: Vocal Fatigue Index (VFI)
timeFrame: baseline (twice before the intervention), 3 weeks (immediately after the intervention), 3 weeks follow-up, 3 months follow-up
measure: Singing Voice Handicap Index 10 (SVHI-10)
timeFrame: baseline (twice before the intervention), 3 weeks (immediately after the intervention), 3 weeks follow-up, 3 months follow-up
measure: Evaluation of Ability to Sing Easily (EASE-NL)
timeFrame: baseline (twice before the intervention), 3 weeks (immediately after the intervention), 3 weeks follow-up, 3 months follow-up
Other outcomes:
Locations:
city: Ghent
country: Belgium
facility: Ghent University
state: East-Flanders
Study officials:
affiliation: University Ghent
name: Evelien D'haeseleer
role: PRINCIPAL_INVESTIGATOR
References: