Efficacy of Flow Ball Phonation in Professional Voice Users
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Flow Ball Intervention, Straw Phonation Intervention, Sham Intervention.
- Who it may be relevant to
- Registry conditions: Prevention of Voice Disorders in Professional Voice Users, Treatment of Functional Voice Disorders in Professional Voice Users. Basic parameters: 18 years — 60 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Belgium
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Interventions
- Behavioral Flow Ball Intervention
Participants receive an intensive intervention using the Flow Ball device over 3 weeks (a total of 5 hours), consisting of weekly: * 1 in-person guided session of 30 minutes * 2 guided online sessions of 15 minutes each (via teleconsult) * On the remaining 4 days of the week, participants perform independent training at home: 5 minutes, twice daily. This training is recorded using the app 'MyMedicoach' - Behavioral Straw Phonation Intervention
Participants receive an intensive intervention using a straw over 3 weeks (a total of 5 hours), consisting of weekly: * 1 in-person guided session of 30 minutes * 2 guided online sessions of 15 minutes each (via teleconsult) * On the remaining 4 days of the week, participants perform independent training at home: 5 minutes, twice daily. This training is recorded using the app 'MyMedicoach' - Behavioral Sham Intervention
Participants receive an intensive intervention over 3 weeks (a total of 5 hours), consisting of weekly: * 1 in-person guided session of 30 minutes * 2 guided online sessions of 15 minutes each (via teleconsult) * On the remaining 4 days of the week, participants perform independent training at home: 5 minutes, twice daily. This training is recorded using the app 'MyMedicoach' The sham intervention uses breathing exercises through the Flow Ball, no phonation will be involved.
Primary outcome measures
- Flexible Strobovideolaryngoscopy [Time frame: baseline (before the intervention) and 3 weeks (immediately after the intervention)]
- Dysphonia Severity Index (DSI) [Time frame: baseline (twice before the intervention), 3 weeks (immediately after the intervention), 3 weeks follow-up, 3 months follow-up]
- Acoustic Voice Quality Index (AVQI) [Time frame: baseline (twice before the intervention), 3 weeks (immediately after the intervention), 3 weeks follow-up, 3 months follow-up]
- Consensus Auditory-Perceptual Evaluation of Voice (CAPE-V) [Time frame: baseline (twice before the intervention), 3 weeks (immediately after the intervention), 3 weeks follow-up, 3 months follow-up]
- Voice Handicap Index [Time frame: baseline (twice before the intervention), 3 weeks (immediately after the intervention), 3 weeks follow-up, 3 months follow-up]
Secondary outcome measures (10)
- Maximum phonation time (MPT) [Time frame: baseline (twice before the intervention), 3 weeks (immediately after the intervention), 3 weeks follow-up, 3 months follow-up]
- Fundamental frequency (fo) [Time frame: baseline (twice before the intervention), 3 weeks (immediately after the intervention), 3 weeks follow-up, 3 months follow-up]
- Jitter [Time frame: baseline (twice before the intervention), 3 weeks (immediately after the intervention), 3 weeks follow-up, 3 months follow-up]
- Shimmer [Time frame: baseline (twice before the intervention), 3 weeks (immediately after the intervention), 3 weeks follow-up, 3 months follow-up]
- Noise to Harmonics Ratio (NHR) [Time frame: baseline (twice before the intervention), 3 weeks (immediately after the intervention), 3 weeks follow-up, 3 months follow-up]
- Voice Range Profile (VRP) [Time frame: baseline (twice before the intervention), 3 weeks (immediately after the intervention), 3 weeks follow-up, 3 months follow-up]
- Vocal Tract Discomfort Scale (VTDS) [Time frame: baseline (twice before the intervention), 3 weeks (immediately after the intervention), 3 weeks follow-up, 3 months follow-up]
- Vocal Fatigue Index (VFI) [Time frame: baseline (twice before the intervention), 3 weeks (immediately after the intervention), 3 weeks follow-up, 3 months follow-up]
- Singing Voice Handicap Index 10 (SVHI-10) [Time frame: baseline (twice before the intervention), 3 weeks (immediately after the intervention), 3 weeks follow-up, 3 months follow-up]
- Evaluation of Ability to Sing Easily (EASE-NL) [Time frame: baseline (twice before the intervention), 3 weeks (immediately after the intervention), 3 weeks follow-up, 3 months follow-up]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Treatment
Study locations
Belgium · 1 center
- Ghent University — Ghent
Identifiers
NCT: NCT06960772 · ONZ-2025-0017