Clinical trial NCT06126627: Brain and Voice Signatures in Teachers
Official title: Neurobiological and Psychobiological Signatures of Vocal Effort in Early Career Teachers
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Voice Disorders
Voice Fatigue
Keywords: voice disorders
vocal fatigue
occupational voice disorders
stress reactivity
vocal control
laryngeal motor cortex
teachers
speech motor control
voice motor control
Lead sponsor: University Hospital, Bonn
Sponsor class: OTHER
First posted: 2023-11-13
Enrollment: 100
Sex: FEMALE
Minimum age (years): 21
Maximum age (years): 39
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

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.

Exclusion Criteria:

* 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

Primary outcomes:
measure: Vocal fatigue
timeFrame: through study completion, an average of 1 month
measure: BOLD MRI area 4p
timeFrame: through study completion, an average of 1 month
measure: Salivary cortisol
timeFrame: through study completion, an average of 1 month
measure: Suprahyoid muscle activity
timeFrame: through study completion, an average of 1 month
measure: Infrahyoid muscle activity
timeFrame: through study completion, an average of 1 month
measure: Personality, Social Potency
timeFrame: through study completion, an average of 1 month
measure: Personality, Stress Reaction
timeFrame: through study completion, an average of 1 month
measure: Personality, social anxiety
timeFrame: through study completion, an average of 1 month
Secondary outcomes:
measure: Vocal fatigue
timeFrame: through study completion, an average of 1 month
measure: Voice quality of life
timeFrame: through study completion, an average of 1 month
measure: Vocal tract discomfort
timeFrame: through study completion, an average of 1 month
measure: Informal questionnaire on vocal health
timeFrame: through study completion, an average of 1 month
measure: BOLD MRI SMA
timeFrame: through study completion, an average of 1 month
measure: BOLD MRI ACC
timeFrame: through study completion, an average of 1 month
measure: BOLD MRI MCC
timeFrame: through study completion, an average of 1 month
measure: BOLD MRI Amygdala
timeFrame: through study completion, an average of 1 month
measure: BOLD MRI PAG
timeFrame: through study completion, an average of 1 month
measure: Personality, Wellbeing
timeFrame: through study completion, an average of 1 month
measure: Personality, Social Closeness
timeFrame: through study completion, an average of 1 month
measure: Personality, social anxiety
timeFrame: through study completion, an average of 1 month
measure: Personality, self-esteem
timeFrame: through study completion, an average of 1 month
measure: Behavioral inhibition and exhibition
timeFrame: through study completion, an average of 1 month
measure: Chronic Stress
timeFrame: through study completion, an average of 1 month
measure: Handedness
timeFrame: through study completion, an average of 1 month
measure: State positive and negative affect
timeFrame: through study completion, an average of 1 month
measure: Voice quality, relative fundamental frequency
timeFrame: through study completion, an average of 1 month
measure: Voice quality, cepstral-spectral analysis
timeFrame: through study completion, an average of 1 month
measure: Perceived vocal effort
timeFrame: through study completion, an average of 1 month
measure: Cognitive effort
timeFrame: through study completion, an average of 1 month
Other outcomes:
Locations:
city: Bonn
country: Germany
facility: University Hospital Bonn
Study officials:
affiliation: University Hospital, Bonn
name: Maria Dietrich, PhD
role: PRINCIPAL_INVESTIGATOR
References: