Brain and Voice Signatures in Teachers

Voice Disorders Clinical Trial

— BRAVO1  

Official title:

Neurobiological and Psychobiological Signatures of Vocal Effort in Early Career Teachers

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06126627
• Other study ID #: R01DC018026
• Status: Recruiting
• Phase: N/A
• Start date: August 1, 2023
• Est. completion date: August 2024

Study information

• Verified date: November 2023
• Source: University Hospital, Bonn
• Contact: Maria Dietrich, PhD
• Phone: +49228287
• Email: Maria.Dietrich[@]ukbonn.de
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: August 2024
• Est. primary completion date: August 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 21 Years to 39 Years

Eligibility

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

Related Conditions & MeSH terms

• Fatigue
• Voice Disorders

Intervention

Behavioral:
• Stress induction
Induction of anticipatory stress to compare voice and speech control and production with and without exposure to stress.

Locations

Country	Name	City	State
Germany	University Hospital Bonn	Bonn

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Bonn

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Vocal fatigue	Raw scores, Vocal Fatigue Index, VFI Factor 1	through study completion, an average of 1 month
Primary	BOLD MRI area 4p	MRI activation in regions of interest (BOLD area 4p in mean %) as a function of speech tasks with and without stress induction	through study completion, an average of 1 month
Primary	Salivary cortisol	Salivary cortisol (nmol/L) to determine stressresponders and nonresponders	through study completion, an average of 1 month
Primary	Suprahyoid muscle activity	Suprahyoid muscle activity (RMS)	through study completion, an average of 1 month
Primary	Infrahyoid muscle activity	Infrahyoid muscle activity (RMS)	through study completion, an average of 1 month
Primary	Personality, Social Potency	Personality trait Social Potency (T-scores, Multidimensional Personality Questionnaire, MPQ)	through study completion, an average of 1 month
Primary	Personality, Stress Reaction	Personality trait Stress Reaction (T-scores, Multidimensional Personality Questionnaire, MPQ)	through study completion, an average of 1 month
Primary	Personality, social anxiety	Personality trait social anxiety (T-scores, Liebowitz Social Anxiety Scale, LSAS-fear)	through study completion, an average of 1 month
Secondary	Vocal fatigue	Raw scores, Vocal Fatigue Index, VFI Factor 2 and 3	through study completion, an average of 1 month
Secondary	Voice quality of life	Raw data, Voice Handicap Index, VHI	through study completion, an average of 1 month
Secondary	Vocal tract discomfort	Raw data, Vocal Tract Discomfort Scale, VTD	through study completion, an average of 1 month
Secondary	Informal questionnaire on vocal health	Raw data informal questionnaire on vocal health	through study completion, an average of 1 month
Secondary	BOLD MRI SMA	MRI activation in regions of interest (BOLD area SMA in mean %) as a function of speech tasks with and without stress induction	through study completion, an average of 1 month
Secondary	BOLD MRI ACC	MRI activation in regions of interest (BOLD area ACC in mean %) as a function of speech tasks with and without stress induction	through study completion, an average of 1 month
Secondary	BOLD MRI MCC	MRI activation in regions of interest (BOLD area MCC in mean %) as a function of speech tasks with and without stress induction	through study completion, an average of 1 month
Secondary	BOLD MRI Amygdala	MRI activation in regions of interest (BOLD area Amygdala in mean %) as a function of speech tasks with and without stress induction	through study completion, an average of 1 month
Secondary	BOLD MRI PAG	MRI activation in regions of interest (BOLD area PAG in mean %) as a function of speech tasks with and without stress induction	through study completion, an average of 1 month
Secondary	Personality, Wellbeing	Personality trait Wellbeing (T-scores, Multidimensional Personality Questionnaire, MPQ)	through study completion, an average of 1 month
Secondary	Personality, Social Closeness	Personality trait Social Closeness (T-scores, Multidimensional Personality Questionnaire, MPQ)	through study completion, an average of 1 month
Secondary	Personality, social anxiety	Personality trait social anxiety (T-scores, Liebowitz Social Anxiety Scale, LSAS-total)	through study completion, an average of 1 month
Secondary	Personality, self-esteem	Personality self-esteem (raw data, Rosenberg self-esteem scale)	through study completion, an average of 1 month
Secondary	Behavioral inhibition and exhibition	Behavioral inhibition and exhibition (raw data, BIS/BAS scales, BIS subscale)	through study completion, an average of 1 month
Secondary	Chronic Stress	Chronic stress (T-scores, Trier Inventory of Chronic Stress, TICS)	through study completion, an average of 1 month
Secondary	Handedness	Handedness (raw data, Edinburgh Handedness Inventory, EHI)	through study completion, an average of 1 month
Secondary	State positive and negative affect	State positive and negative affect (raw data, Positive and Negative Affect Schedule, PANAS)	through study completion, an average of 1 month
Secondary	Voice quality, relative fundamental frequency	Voice quality, relative fundamental frequency (relative fundamental frequency, RFF in semitones [ST])	through study completion, an average of 1 month
Secondary	Voice quality, cepstral-spectral analysis	Voice quality, cepstral-spectral analysis (cepstral peak prominence in dB)	through study completion, an average of 1 month
Secondary	Perceived vocal effort	Perceived vocal effort (raw data, BORG-CR-10)	through study completion, an average of 1 month
Secondary	Cognitive effort	Cognitive effort (raw data, NASA-TLX)	through study completion, an average of 1 month