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临床试验/NCT03410797
NCT03410797已完成不适用

Efficacy of a Semi-occluded Mask in the Treatment of Patients With Voice Disorders

Jacqueline Gartner-Schmidt2 个研究点 分布在 1 个国家目标入组 11 人开始时间: 2018年6月19日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
11
试验地点
2
主要终点
Change From Baseline in VHI-10 Score After 4 Sessions of Voice Therapy

研究概览

简要总结

Current semi-occluded vocal tract therapies limit the type of vocalizations that can be produced to single vowels, which does not promote learning of the healthy voice behavior in connected speech or generalization to conversation. However, recent preliminary results using a semi-occluded mask indicate that the use of certain mask port diameters may allow for natural speech production while increasing supraglottal pressure and impedance, and thereby result in elicitation of voice with increased efficiency. In addition, the use of a semi-occluded mask provides the possibility for a better transition from phonating single phonemes in therapy to training the target therapy techniques in connected speech.

详细描述

Treatment of voice disorders varies but often involves voice therapy and/or surgical intervention. Voice therapy, a non-invasive behavioral treatment for voice disorders, helps patients develop beneficial voice habits, prevents recurrence of voice disorders, and facilitates long-lasting vocal improvement. Many voice therapy techniques involve a semi-occluded vocal tract (SOVT). SOVT treatment is often characterized by sustained (straw phonation, voiced fricatives, nasals), oral oscillatory (lip buzzes, tongue trills, raspberries) or transitory phonation (plosives and glides). Straw phonation therapy, one of the most utilized SOVT methods, was first proposed in 1904 and involved phonating at different pitches into small glass tubes with varying diameters and lengths providing simultaneous semi-occlusion and extension of the vocal tract. Voice therapy exercises involving voice production with a semi-occluded and sometimes lengthened vocal tract have demonstrated improved vocal efficiency and loudness, reduced mechanical trauma to the vocal fold mucosa, and improved source-filter interaction.Our group recently developed a semi-occluded facemask for use in patients with and without voice disorders. Recent preliminary results using this semi-occluded facemask indicated that the use of a certain mask port diameters may elicit voice with increased efficiency. A study of 5 participants without voice disorders revealed that a mask occlusion diameter of 6.4 and 3.2 mm resulted in improved vocal efficiency. A study of the immediate effects of a semi-occluded facemask in 20 patients with voice disorders revealed that occlusions diameters of 9.6, 6.4, and 3.2 mm all resulted in significant improvements in acoustic and aerodynamic voice outcomes.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 60 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • age 18 to 60
  • diagnosed with vocal fold lesion or polyp or cyst or atrophy or other voice condition (such as muscle tension dysphonia)
  • recommended for voice therapy as treatment for voice disorder

排除标准

  • Current smoker (greater than 5 cigarettes/week)

结局指标

主要结局

Change From Baseline in VHI-10 Score After 4 Sessions of Voice Therapy

时间窗: Baseline and approximately 6-8 weeks later; after completion of voice therapy

VHI-10 is a 10 item, self reported, voice related outcome related to an individual's perception of their vocal quality and how it impacts their life. (Voice Handicap Index) Scale scores range from 0-40 where higher scores correspond to a worse vocal quality.

次要结局

  • Change From Baseline in Cepstral Spectral Index of Dysphonia (CSID--a Multivariate Estimate of Dysphonia Severity)(Baseline and approximately 6-8 weeks later; after completion of voice therapy)
  • Change From Baseline in Mean Airflow in Milliliters (ml) During Reading of Standardized Paragraph(Baseline and approximately 6-8 weeks later; after completion of voice therapy)
  • Change From Baseline in Mean Vocal Intensity (dB)(Baseline and approximately 6-8 weeks later; after completion of voice therapy)
  • Change From Baseline in Cepstral Peak Prominence (dB)(Baseline and approximately 6-8 weeks later; after completion of voice therapy)
  • Change in the Number of Breaths Taken During Reading of Standardized Paragraph(Baseline to post treatment)

研究者

发起方
Jacqueline Gartner-Schmidt
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Jacqueline Gartner-Schmidt

Professor

University of Pittsburgh

研究点 (2)

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