Efficacy of Flow Ball Phonation in Professional Voice Users
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 144
- 试验地点
- 1
- 主要终点
- Flexible Strobovideolaryngoscopy
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •OBJECTIVE 1: TREATMENT
- •Inclusion Criteria:
- •All genders
- •All ethnicities
- •18 - 60 years
- •Diagnosis of a functional voice disorder
- •Professional voice users
排除标准
- •Diagnosis of an organic voice disorder
- •Current participation in voice therapy
- •Previous phonosurgical interventions
- •Pregnancy
- •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
- •Nasal or ear diseases
- •Neurological disorders
研究组 & 干预措施
Flow Ball
干预措施: Flow Ball Intervention (Behavioral)
Straw Phonation
干预措施: Straw Phonation Intervention (Behavioral)
Sham Intervention
干预措施: Sham Intervention (Behavioral)
结局指标
主要结局
Flexible Strobovideolaryngoscopy
时间窗: baseline (before the intervention) and 3 weeks (immediately after the intervention)
Laryngeal function determined with the Voice-Vibratory Assessment with Laryngeal Imaging (VALI) rating form (Poburka et al., 2017).
Dysphonia Severity Index (DSI)
时间窗: baseline (twice before the intervention), 3 weeks (immediately after the intervention), 3 weeks follow-up, 3 months follow-up
DSI: A higher index indicates a better voice quality. The index ranges from -5 to +5 for severely dysphonic to normal voices. A more negative index indicates a worse voice quality. Values \> +5 are possible in subjects with excellent vocal capacities. A DSI = +1.6 is the threshold separating normophonic from dysphonic persons.
Acoustic Voice Quality Index (AVQI)
时间窗: baseline (twice before the intervention), 3 weeks (immediately after the intervention), 3 weeks follow-up, 3 months follow-up
A lower AVQI indicates a better voice quality. The index ranges from 0 to 10 for normal to severely dysphonic voices. An AVQI of 2.95 is the threshold separating normophonic from dysphonic persons.
Consensus Auditory-Perceptual Evaluation of Voice (CAPE-V)
时间窗: baseline (twice before the intervention), 3 weeks (immediately after the intervention), 3 weeks follow-up, 3 months follow-up
The CAPE-V will be used to provide an auditory-perceptual evaluation of the voice quality. This visual analogue scale will examine the voice based on the parameters grade, roughness, breathiness, asthenia, strain, instability, pitch and loudness.
Voice Handicap Index
时间窗: baseline (twice before the intervention), 3 weeks (immediately after the intervention), 3 weeks follow-up, 3 months follow-up
VHI: A lower index indicates less impact of the voice impairment on the quality of life. The VHI ranges from 0 to 120.
次要结局
- Maximum phonation time (MPT)(baseline (twice before the intervention), 3 weeks (immediately after the intervention), 3 weeks follow-up, 3 months follow-up)
- Fundamental frequency (fo)(baseline (twice before the intervention), 3 weeks (immediately after the intervention), 3 weeks follow-up, 3 months follow-up)
- Jitter(baseline (twice before the intervention), 3 weeks (immediately after the intervention), 3 weeks follow-up, 3 months follow-up)
- Shimmer(baseline (twice before the intervention), 3 weeks (immediately after the intervention), 3 weeks follow-up, 3 months follow-up)
- Noise to Harmonics Ratio (NHR)(baseline (twice before the intervention), 3 weeks (immediately after the intervention), 3 weeks follow-up, 3 months follow-up)
- Voice Range Profile (VRP)(baseline (twice before the intervention), 3 weeks (immediately after the intervention), 3 weeks follow-up, 3 months follow-up)
- Vocal Tract Discomfort Scale (VTDS)(baseline (twice before the intervention), 3 weeks (immediately after the intervention), 3 weeks follow-up, 3 months follow-up)
- Vocal Fatigue Index (VFI)(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)(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)(baseline (twice before the intervention), 3 weeks (immediately after the intervention), 3 weeks follow-up, 3 months follow-up)