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临床试验/NCT06126627
NCT06126627招募中不适用

Neurobiological and Psychobiological Signatures of Vocal Effort in Early Career Teachers

University Hospital, Bonn2 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2023年8月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
100
试验地点
2
主要终点
Personality, Stress Reaction

研究概览

简要总结

Primary muscle tension dysphonia voice disorder with symptoms of vocal strain and vocal fatigue is common and can have a significant negative impact on quality of Life. Yet, primary muscle tension dysphonia's causes are unknown precluding precise diagnostic classification. Stress and personality are thought to play a role and thus, the project aims to determine the practical and clinical effect of stress on the control of voice and speech in the brain. Participants are female early career teachers and student teachers with symptoms of vocal fatigue, as well as control participants without vocal fatigue, who perform speech tasks on two different occasions. Neural (imaging of brain), psychobiological (saliva, personality), and voice and speech (muscle activity of voice muscles on the neck with surface sensors, audio recordings) data will compare reactivity patterns of teachers who are stressresponders with those who are nonresponders as well as control participants. The central hypothesis is that voice box stress responders have heightened emotion-motor activations involving the emotional voice production pathway, which correlate with changes in voice muscle activity in the anterior neck. The results will provide fundamentally missing data in our understanding of the role of stress in vocal complaints and will yield new insights about the neural underpinnings of primary muscle tension dysphonia. The study findings will have a significant impact on how clinicians identify so-called laryngoresponders to help them prevent voice disorders.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Basic Science
盲法
None

入排标准

年龄范围
21 Years 至 39 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Teachers (max. 10 years full-time) or student teachers in good health between 21 and 39 years with symptoms of vocal fatigue.
  • Control participants in good health between 21 and 39 years without symptoms of vocal fatigue.

排除标准

  • Lefthandedness
  • Smoking (past 5 years)
  • Known changes of the vocal folds (e.g., vocal fold nodules), vocal fold paralysis, surgeries on the larynx or thryoid or current organic or neurological changes of the vocal folds or vocal function per videoendoscopy and -stroboscopy of the larynx
  • History of voice therapy
  • Hoarseness
  • Respiratory illness, allergies (respiratory, silver), reflux or asthma at time of participation
  • Hearing disorder or hearing aids
  • Psychological, neurological or endocrinological disorders
  • Psychotropic or steorid medications
  • Body mass index > 30
  • Indications against MRI such as metail parts in or on the body (e.g., permanent dental prostheses or braces, screws, prostheses, piercings or large tattoos
  • Nearsightedness > -5 diopters, if only glasses are worn
  • Claustrophobia
  • Pregnancy

结局指标

主要结局

Personality, Stress Reaction

时间窗: through study completion, an average of 1 month

Personality trait Stress Reaction (T-scores, Multidimensional Personality Questionnaire, MPQ)

Salivary cortisol

时间窗: through study completion, an average of 1 month

Salivary cortisol (nmol/L) to determine stressresponders and nonresponders

Infrahyoid muscle activity

时间窗: through study completion, an average of 1 month

Infrahyoid muscle activity (RMS)

Personality, social anxiety

时间窗: through study completion, an average of 1 month

Personality trait social anxiety (T-scores, Liebowitz Social Anxiety Scale, LSAS-fear)

Suprahyoid muscle activity

时间窗: through study completion, an average of 1 month

Suprahyoid muscle activity (RMS)

Personality, Social Potency

时间窗: through study completion, an average of 1 month

Personality trait Social Potency (T-scores, Multidimensional Personality Questionnaire, MPQ)

Vocal fatigue

时间窗: through study completion, an average of 1 month

Raw scores, Vocal Fatigue Index, VFI Factor 1

BOLD MRI area 4p

时间窗: through study completion, an average of 1 month

MRI activation in regions of interest (BOLD area 4p in mean %) as a function of speech tasks with and without stress induction

次要结局

  • Personality, Wellbeing(through study completion, an average of 1 month)
  • BOLD MRI Amygdala(through study completion, an average of 1 month)
  • Personality, Social Closeness(through study completion, an average of 1 month)
  • Personality, social anxiety(through study completion, an average of 1 month)
  • Vocal tract discomfort(through study completion, an average of 1 month)
  • Voice quality of life(through study completion, an average of 1 month)
  • BOLD MRI SMA(through study completion, an average of 1 month)
  • Personality, self-esteem(through study completion, an average of 1 month)
  • Handedness(through study completion, an average of 1 month)
  • Voice quality, relative fundamental frequency(through study completion, an average of 1 month)
  • Perceived vocal effort(through study completion, an average of 1 month)
  • Vocal fatigue(through study completion, an average of 1 month)
  • Informal questionnaire on vocal health(through study completion, an average of 1 month)
  • BOLD MRI MCC(through study completion, an average of 1 month)
  • State positive and negative affect(through study completion, an average of 1 month)
  • Voice quality, cepstral-spectral analysis(through study completion, an average of 1 month)
  • BOLD MRI ACC(through study completion, an average of 1 month)
  • BOLD MRI PAG(through study completion, an average of 1 month)
  • Behavioral inhibition and exhibition(through study completion, an average of 1 month)
  • Chronic Stress(through study completion, an average of 1 month)
  • Cognitive effort(through study completion, an average of 1 month)

研究者

发起方
University Hospital, Bonn
申办方类型
Other
责任方
Principal Investigator
主要研究者

Maria Dietrich

Research Associate

University Hospital, Bonn

研究点 (2)

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