Voice DisordersBRAVO1NCT06126627
Brain and Voice Signatures in Teachers
A study testing Stress induction in people with Voice Disorders and Voice Fatigue, run by University Hospital, Bonn at 1 site in Germany.
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. Read more about this study
- Who is it for?
- Ages 21 to 39 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Voice Disorders, Voice Fatigue
- What is being tested?
- Stress induction
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteGermany
- Study dates
- 1 Aug 2023to 31 Jul 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 39 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 14Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Germany1 site, 1 recruiting
- Recruiting
University Hospital Bonn
Bonn, 53127
Maria Dietrich, PhD, +49228287 ext. 11107, Maria.Dietrich@ukbonn.de
About this study
Official title: Neurobiological and Psychobiological Signatures of Vocal Effort in Early Career Teachers
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.
- Conditions
- Voice Disorders, Voice Fatigue
- Being tested
- Stress induction
- Keywords
- voice disorders, vocal fatigue, occupational voice disorders, stress reactivity, vocal control, laryngeal motor cortex, teachers, speech motor control, voice motor control
- Medical subject headings
- Voice Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stress inductionBehavioural
Induction of anticipatory stress to compare voice and speech control and production with and without exposure to stress.
| Study group | Role | What they receive |
|---|---|---|
| Teachers/student teachers with vocal fatigue | Experimental | Teachers/student teachers with vocal fatigue based on Vocal Fatigue Index (VFI, German). Pre-Screening and Screening. Experiment 1: MRI with MRI-compatible surface electrodes on the neck and audio recordings during MRI with and without stress induction. Prior to MRI, questionnaires on voice, personality, and stress and practice oft the tasks. During experiment, collection of saliva samples (before, during, and after MRI). During MRI, multiple subjective ratings of emotional state by the participants. Experiment 2 (approximately 2 weeks later): Speech tasks with surface electromyographic sensors applied to the neck with concurrent audio recordings. Prior to the experiment questionnaires on voice and practice of tasks. Subjective ratings of vocal and cognitive effort during the experiment by the participants. Receives: Behavioral: Stress induction |
| Control group | Active comparator | Control participants without vocal fatigue based on Vocal Fatigue Index (VFI, German). Same experimental procedures as in arm 1. Receives: Behavioral: Stress induction |
What is being measured
The primary outcome is the main question the study is designed to answer.
Vocal fatigue
Raw scores, Vocal Fatigue Index, VFI Factor 1
Measured: through study completion, an average of 1 month
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
Measured: through study completion, an average of 1 month
Salivary cortisol
Salivary cortisol (nmol/L) to determine stressresponders and nonresponders
Measured: through study completion, an average of 1 month
Suprahyoid muscle activity
Suprahyoid muscle activity (RMS)
Measured: through study completion, an average of 1 month
Infrahyoid muscle activity
Infrahyoid muscle activity (RMS)
Measured: through study completion, an average of 1 month
Personality, Social Potency
Personality trait Social Potency (T-scores, Multidimensional Personality Questionnaire, MPQ)
Measured: through study completion, an average of 1 month
Personality, Stress Reaction
Personality trait Stress Reaction (T-scores, Multidimensional Personality Questionnaire, MPQ)
Measured: through study completion, an average of 1 month
Personality, social anxiety
Personality trait social anxiety (T-scores, Liebowitz Social Anxiety Scale, LSAS-fear)
Measured: through study completion, an average of 1 month
Secondary outcomes (21)
Vocal fatigue
Raw scores, Vocal Fatigue Index, VFI Factor 2 and 3
Measured: through study completion, an average of 1 month
Voice quality of life
Raw data, Voice Handicap Index, VHI
Measured: through study completion, an average of 1 month
Vocal tract discomfort
Raw data, Vocal Tract Discomfort Scale, VTD
Measured: through study completion, an average of 1 month
Informal questionnaire on vocal health
Raw data informal questionnaire on vocal health
Measured: through study completion, an average of 1 month
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
Measured: through study completion, an average of 1 month
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
Measured: through study completion, an average of 1 month
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
Measured: through study completion, an average of 1 month
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
Measured: through study completion, an average of 1 month
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
Measured: through study completion, an average of 1 month
Personality, Wellbeing
Personality trait Wellbeing (T-scores, Multidimensional Personality Questionnaire, MPQ)
Measured: through study completion, an average of 1 month
Personality, Social Closeness
Personality trait Social Closeness (T-scores, Multidimensional Personality Questionnaire, MPQ)
Measured: through study completion, an average of 1 month
Personality, social anxiety
Personality trait social anxiety (T-scores, Liebowitz Social Anxiety Scale, LSAS-total)
Measured: through study completion, an average of 1 month
Personality, self-esteem
Personality self-esteem (raw data, Rosenberg self-esteem scale)
Measured: through study completion, an average of 1 month
Behavioral inhibition and exhibition
Behavioral inhibition and exhibition (raw data, BIS/BAS scales, BIS subscale)
Measured: through study completion, an average of 1 month
Chronic Stress
Chronic stress (T-scores, Trier Inventory of Chronic Stress, TICS)
Measured: through study completion, an average of 1 month
Handedness
Handedness (raw data, Edinburgh Handedness Inventory, EHI)
Measured: through study completion, an average of 1 month
State positive and negative affect
State positive and negative affect (raw data, Positive and Negative Affect Schedule, PANAS)
Measured: through study completion, an average of 1 month
Voice quality, relative fundamental frequency
Voice quality, relative fundamental frequency (relative fundamental frequency, RFF in semitones [ST])
Measured: through study completion, an average of 1 month
Voice quality, cepstral-spectral analysis
Voice quality, cepstral-spectral analysis (cepstral peak prominence in dB)
Measured: through study completion, an average of 1 month
Perceived vocal effort
Perceived vocal effort (raw data, BORG-CR-10)
Measured: through study completion, an average of 1 month
Cognitive effort
Cognitive effort (raw data, NASA-TLX)
Measured: through study completion, an average of 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2023
- Study start1 Aug 2023
- Primary completion30 Jun 2026 (estimated)
- Study completion31 Jul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Voice DisordersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Bonn
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Maria Dietrich, University Hospital, Bonn
- Investigators
- Maria Dietrich, PhD, Principal investigator, University Hospital, Bonn
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06126627
- Sponsor's protocol ID
- R01DC018026
- Acronym
- BRAVO1
- Status last verified
- Aug 2025
- First submitted
- 19 Oct 2023
- Last updated
- 27 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The raw data, on which the conclusions are based, will be shared by the authors without any inadmissible caveats starting 6 months post publication with any qualified researcher upon request.
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neurobiological and Psychobiological Signatures of Vocal Effort in Early Career Teachers
- ClinicalTrials.gov ID
- NCT06126627
- Acronym / sponsor ID
- BRAVO1 / R01DC018026
- Conditions
- Voice Disorders, Voice Fatigue
- Keywords
- voice disorders, vocal fatigue, occupational voice disorders, stress reactivity, vocal control, laryngeal motor cortex, teachers, speech motor control
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University Hospital, BonnUniversity, hospital or other
- Study start
- 1 Aug 2023 (actual)
- Primary completion
- 30 Jun 2026 (estimated)
- Study completion
- 31 Jul 2026 (estimated)
- First posted
- 13 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Teachers/student teachers with vocal fatigue | Experimental | Behavioral: Stress inductionTeachers/student teachers with vocal fatigue based on Vocal Fatigue Index (VFI, German). Pre-Screening and Screening. Experiment 1: MRI with MRI-compatible surface electrodes on the neck and audio recordings during MRI with and without stress induction. Prior to MRI, questionnaires on voice, personality, and stress and practice oft the tasks. During experiment, collection of saliva samples (before, during, and after MRI). During MRI, multiple subjective ratings of emotional state by the participants. Experiment 2 (approximately 2 weeks later): Speech tasks with surface electromyographic sensors applied to the neck with concurrent audio recordings. Prior to the experiment questionnaires on voice and practice of tasks. Subjective ratings of vocal and cognitive effort during the experiment by the participants. |
| Control group | Active comparator | Behavioral: Stress inductionControl participants without vocal fatigue based on Vocal Fatigue Index (VFI, German). Same experimental procedures as in arm 1. |
Who may qualify
- Ages
- 21 to 39 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (14 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Stress inductionInduction of anticipatory stress to compare voice and speech control and production with and without exposure to stress. | Behavioural | Control group, Teachers/student teachers with vocal fatigue |
Primary outcome
Vocal fatigue
Time frame: through study completion, an average of 1 month
Raw scores, Vocal Fatigue Index, VFI Factor 1
BOLD MRI area 4p
Time frame: 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
Salivary cortisol
Time frame: through study completion, an average of 1 month
Salivary cortisol (nmol/L) to determine stressresponders and nonresponders
Suprahyoid muscle activity
Time frame: through study completion, an average of 1 month
Suprahyoid muscle activity (RMS)
Infrahyoid muscle activity
Time frame: through study completion, an average of 1 month
Infrahyoid muscle activity (RMS)
Personality, Social Potency
Time frame: through study completion, an average of 1 month
Personality trait Social Potency (T-scores, Multidimensional Personality Questionnaire, MPQ)
Personality, Stress Reaction
Time frame: through study completion, an average of 1 month
Personality trait Stress Reaction (T-scores, Multidimensional Personality Questionnaire, MPQ)
Personality, social anxiety
Time frame: through study completion, an average of 1 month
Personality trait social anxiety (T-scores, Liebowitz Social Anxiety Scale, LSAS-fear)
21 secondary outcomes
Vocal fatigue
Time frame: through study completion, an average of 1 month
Voice quality of life
Time frame: through study completion, an average of 1 month
Vocal tract discomfort
Time frame: through study completion, an average of 1 month
Informal questionnaire on vocal health
Time frame: through study completion, an average of 1 month
BOLD MRI SMA
Time frame: through study completion, an average of 1 month
BOLD MRI ACC
Time frame: through study completion, an average of 1 month
BOLD MRI MCC
Time frame: through study completion, an average of 1 month
BOLD MRI Amygdala
Time frame: through study completion, an average of 1 month
BOLD MRI PAG
Time frame: through study completion, an average of 1 month
Personality, Wellbeing
Time frame: through study completion, an average of 1 month
Personality, Social Closeness
Time frame: through study completion, an average of 1 month
Personality, social anxiety
Time frame: through study completion, an average of 1 month
Personality, self-esteem
Time frame: through study completion, an average of 1 month
Behavioral inhibition and exhibition
Time frame: through study completion, an average of 1 month
Chronic Stress
Time frame: through study completion, an average of 1 month
Handedness
Time frame: through study completion, an average of 1 month
State positive and negative affect
Time frame: through study completion, an average of 1 month
Voice quality, relative fundamental frequency
Time frame: through study completion, an average of 1 month
Voice quality, cepstral-spectral analysis
Time frame: through study completion, an average of 1 month
Perceived vocal effort
Time frame: through study completion, an average of 1 month
Cognitive effort
Time frame: through study completion, an average of 1 month
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Aug 2025.
- Individual participant dataSharing planned: Yes. The raw data, on which the conclusions are based, will be shared by the authors without any inadmissible caveats starting 6 months post publication with any qualified researcher upon request.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Maria Dietrich, PhD principal investigator
University Hospital, Bonn
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Stress induction in people with Voice Disorders and Voice Fatigue, run by University Hospital, Bonn at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 27 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Maria Dietrich, PhD (+49228287 ext. 11107, Maria.Dietrich@ukbonn.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Vocal fatigue (time frame: through study completion, an average of 1 month). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Aug 2025.