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临床试验/NCT06137131
NCT06137131已完成不适用

Voice Therapy With a Semi-occluded Vocal Tract: From Current Challenges to Next Level Efficacy Studies

University Ghent2 个研究点 分布在 1 个国家目标入组 58 人开始时间: 2021年10月7日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
58
试验地点
2
主要终点
(Supra)Glottic Activity: Amplitude of Vibration

研究概览

简要总结

  1. The first objective of this research is to investigate the immediate effects of three semi-occluded vocal tract (SOVT) exercises (straw phonation in air, straw phonation in 2cm water, and straw phonation in 5cm water) on (supra)glottic activity of vocally healthy participants and patients with voice disorders (dysphonia) visualized with laryngovideostroboscopy.

Participants will receive a flexible laryngovideostroboscopy, both during normal phonation and during the specific SOVT exercise. These videos will be randomly and blindly evaluated by two experts using the Voice-Vibratory Assessment with Laryngeal Imaging (VALI) rating form (Poburka et al., 2017).

Researchers will compare the effects of these SOVT exercises on the (supra)glottic activity with the effects found in a control group producing /u/ phonation, using a randomized controlled trial. 2. The second objective of this research is to investigate the short- and long-term effects of the three SOVT therapy approaches on the (supra)glottic activity, voice quality and self-report of patients with voice disorders (dysphonia).

Participants will receive a short-term intensive therapy with the specific SOVT exercise across four weeks.

Immediately after the therapy program and at 1 and 3 months follow-up, the voice of the participants will be re-evaluated.

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
Single (Outcomes Assessor)

入排标准

年龄范围
17 Years 至 50 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

(Supra)Glottic Activity: Amplitude of Vibration

时间窗: baseline (before the intervention)

Laryngeal function determined with the Voice-Vibratory Assessment with Laryngeal Imaging (VALI) rating form (Poburka et al., 2017). Amplitude of vibration: magnitude of lateral movement of the vocal folds. This is a visual-perceptual evaluation based on the video samples of the strobovideolaryngoscopy. Raters score the magnitude of lateral movement of the vocal folds based on the graphic of the VALI form ranging from 0 to 10, this number is then multiplied by 10 to obtain a percentage. Lower percentages mean a smaller amplitude of vibration, higher percentages mean a larger amplitude of vibration.

Supraglottic Activity: Anteroposterior Compression

时间窗: baseline (before the intervention)

Laryngeal function determined with the VALI form (Poburka et al, 2017). Anteroposterior supraglottic compression: constriction of the supraglottic structures in the anteroposterior dimension. This is a visual-perceptual evaluation based on the video samples of the strobovideolaryngoscopy. Raters score the supraglottic compression based on the graphic of the VALI form on a scale ranging from 0 to 5 (with the aid of concentric circles). The higher the number, the more supraglottic compression. More supraglottic compression is often seen as a negative outcome, however it might be a beneficial effect seen in SOVT phonation studied here.

次要结局

  • Voice Quality Index 1: Dysphonia Severity Index (DSI)(baseline (before the intervention), 1 month (immediately after the intervention), 1 month follow-up, 3 months follow-up)
  • Voice Quality Index 2: Acoustic Voice Quality Index (AVQI)(baseline (before the intervention), 1 month (immediately after the intervention), 1 month follow-up, 3 months follow-up)
  • Self-report 1: Voice Handicap Index (VHI)(baseline (before the intervention), 1 month (immediately after the intervention), 1 month follow-up, 3 months follow-up)
  • Self-report 2: Vocal Tract Discomfort Scale (VTDS)(baseline (before the intervention), 1 month (immediately after the intervention), 1 month follow-up, 3 months follow-up)
  • Self-report 3: Vocal Fatigue Index (VFI)(baseline (before the intervention), 1 month (immediately after the intervention), 1 month follow-up, 3 months follow-up)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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