Efficacy of Flow Ball Phonation in Professional Voice Users

Обзор

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.

Подробное описание

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.

Вмешательства

• Поведенческое 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'
• Поведенческое 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'
• Поведенческое 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.

Первичные конечные точки

• Flexible Strobovideolaryngoscopy [Срок оценки: baseline (before the intervention) and 3 weeks (immediately after the intervention)]
• Dysphonia Severity Index (DSI) [Срок оценки: baseline (twice before the intervention), 3 weeks (immediately after the intervention), 3 weeks follow-up, 3 months follow-up]
• Acoustic Voice Quality Index (AVQI) [Срок оценки: 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) [Срок оценки: baseline (twice before the intervention), 3 weeks (immediately after the intervention), 3 weeks follow-up, 3 months follow-up]
• Voice Handicap Index [Срок оценки: baseline (twice before the intervention), 3 weeks (immediately after the intervention), 3 weeks follow-up, 3 months follow-up]

Вторичные конечные точки (10)

• Maximum phonation time (MPT) [Срок оценки: baseline (twice before the intervention), 3 weeks (immediately after the intervention), 3 weeks follow-up, 3 months follow-up]
• Fundamental frequency (fo) [Срок оценки: baseline (twice before the intervention), 3 weeks (immediately after the intervention), 3 weeks follow-up, 3 months follow-up]
• Jitter [Срок оценки: baseline (twice before the intervention), 3 weeks (immediately after the intervention), 3 weeks follow-up, 3 months follow-up]
• Shimmer [Срок оценки: baseline (twice before the intervention), 3 weeks (immediately after the intervention), 3 weeks follow-up, 3 months follow-up]
• Noise to Harmonics Ratio (NHR) [Срок оценки: baseline (twice before the intervention), 3 weeks (immediately after the intervention), 3 weeks follow-up, 3 months follow-up]
• Voice Range Profile (VRP) [Срок оценки: baseline (twice before the intervention), 3 weeks (immediately after the intervention), 3 weeks follow-up, 3 months follow-up]
• Vocal Tract Discomfort Scale (VTDS) [Срок оценки: baseline (twice before the intervention), 3 weeks (immediately after the intervention), 3 weeks follow-up, 3 months follow-up]
• Vocal Fatigue Index (VFI) [Срок оценки: 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) [Срок оценки: 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) [Срок оценки: baseline (twice before the intervention), 3 weeks (immediately after the intervention), 3 weeks follow-up, 3 months follow-up]

Критерии участия

OBJECTIVE 1: TREATMENT

Критерии включения

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

Критерии исключения

• 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

Критерии включения

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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Двойное слепое

Основная цель

Лечение

Центры проведения

Бельгия · 1 центр

• Ghent University — Ghent

Идентификаторы

NCT: NCT06960772 · ONZ-2025-0017

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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