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临床试验/NCT06439290
NCT06439290招募中不适用

Voice Outcome of Glottoplasty, Cricothyroid Approximation, Thyroplasty, and Chondrolaryngoplasty

University Ghent4 个研究点 分布在 1 个国家目标入组 290 人开始时间: 2024年4月10日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
290
试验地点
4
主要终点
FF 1-5

研究概览

简要总结

The purpose of this study is to measure the short- and long-term voice outcome and outcome predictors of glottoplasty, cricothyroid approximation, thyroplasty, and chondrolaryngoplasty using a prospective non-randomized controlled trial and a multidimensional voice assessment protocol. Secondly, a laryngeal magnetic resonance imaging protocol will be developed to measure pre- and postoperative anatomical factors and compare them with the acoustic changes.

详细描述

Gender-affirming voice surgery (such as glottoplasty, cricothyroid approximation, thyroplasty and chondrolaryngoplasty), in addition to gender-affirming voice training and hormone therapy, plays an important role in achieving a gender-congruent voice in transgender and gender diverse people. In addition, these interventions are sometimes performed on cisgender men or women who wish to change their voice. However, the impact of these interventions on broad voice characteristics needs to be further investigated.

A thyroid chondroplasty is a procedure in which the cartilage of the larynx is flattened to make the larynx ("Adam's apple") less visible. This procedure is sometimes performed in combination with voice surgery. Although clinically in some cases we observe a temporary lowering of the pitch of the voice during thyroid chondroplasty, little is known in the literature about the impact of this surgery on voice characteristics.

The first purpose is to measure the effect of glottoplasty, cricothyroid approximation, thyroplasty and/or thyroid chondroplasty on a) acoustic voice characteristics (such as the pitch and resonance of the voice), b) perception of femininity/masculinity, c) psychosocial well-being and satisfaction and d) the function of the vocal folds.

Persons undergoing a glottoplasty, cricothyroid approximation, thyroplasty and/or thyroid chondroplasty in the head and neck surgery department are routinely invited to several pre- and postoperative check-up appointments in the head and neck surgery and ear, nose and throat department. These people will be invited to participate in the study in which the data, which are routinely collected preoperatively, 1 week, 1 month, 6 months and 12 months postoperatively during a speech-language pathology (SLP) consultation and a head and neck surgery consultation. These data will be used for scientific research to study the outcome of such surgery on phonation. These pre- and post-operative consultations are clinically standard. During these consultations, a voice assessment and videolaryngostroboscopic examination of the vocal folds are routinely performed.

Recordings and images obtained through these studies can be further processed in the context of this scientific research (such as conducting a listening experiment, analyzing (e.g. using the VALI form) and measuring the video laryngostroboscopy results, etc.).

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Diagnostic
盲法
Single (Care Provider)

盲法说明

Assessments will be performed by an ENT specialist and SLP of the research group who is blinded to study evolution and group allocation.

入排标准

年龄范围
18 Years 至 70 Years(Adult, Older 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

FF 1-5

时间窗: pre, post 1 (1 week), post 2 (1 month), post 3 (6 months), post 4 (1 year)

Formant frequencies 1-5

Speaking fo

时间窗: pre, post 1 (1 week), post 2 (1 month), post 3 (6 months), post 4 (1 year)

Speaking fundamental frequency

Perceptual femininity/masculinity score

时间窗: pre, post 1 (1 week), post 2 (1 month), post 3 (6 months), post 4 (1 year)

Self-perception and listener perceptions of femininity and masculinity. Visual analogue scale (0 = very masculine, 100 = very feminine).

次要结局

  • PROMs: Trans Woman Voice Questionnaire(pre, post 1 (1 week), post 2 (1 month), post 3 (6 months), post 4 (1 year))
  • Laryngeal function(pre, post 1 (1 week), post 2 (1 month), post 3 (6 months), post 4 (1 year))
  • Other PROMs(pre, post 1 (1 week), post 2 (1 month), post 3 (6 months), post 4 (1 year))
  • Vocal quality(pre, post 1 (1 week), post 2 (1 month), post 3 (6 months), post 4 (1 year))
  • Vocal capacity(pre, post 1 (1 week), post 2 (1 month), post 3 (6 months), post 4 (1 year))
  • Vocal range(pre, post 1 (1 week), post 2 (1 month), post 3 (6 months), post 4 (1 year))
  • PROMs: Voice Handicap Index(pre, post 1 (1 week), post 2 (1 month), post 3 (6 months), post 4 (1 year))

研究者

申办方类型
Other
责任方
Sponsor

研究点 (4)

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