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RecruitingNCT06126627BRAVO1Updated Aug 27, 2025

Brain and Voice Signatures in Teachers

An interventional study of Stress induction in Voice Disorders and Voice Fatigue, sponsored by University Hospital, Bonn. Recruiting at 1 site in Germany. Open to female participants aged 21 Years to 39 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-08-27.

Sponsored by University Hospital, Bonn · Not applicable, Interventional, and Basic science

From the registry’s dates

  • Primary completion was expected by Jun 2026, 4 months ago, but the record still lists the study as recruiting.
  • Started Aug 2023; still recruiting 3 years 3 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
100
Allocation
Non-randomized
Ages
21 Years to 39 Years
Sex
Female
01

Study 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.

02

Conditions studied

  • Voice Disorders
  • Voice Fatigue

Browse trials for

Keywords

  • voice disorders
  • vocal fatigue
  • occupational voice disorders
  • stress reactivity
  • vocal control
  • laryngeal motor cortex
  • teachers
  • speech motor control
  • voice motor control
03

In context

Voice Disorders

77 studies on the registry are indexed under Voice Disorders; 17 are open to participants now.

This study's planned enrollment of 100 is above the median of 41 across 54 interventional studies indexed under Voice Disorders.

Browse Voice Disorders studies →

Lead sponsor

University Hospital, Bonn is the lead sponsor of 154 studies on the registry; 28 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
21 Years to 39 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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
  • > 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
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

05

Study design

Phase
Not applicable
Primary purpose
Basic science
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
100 participants (estimated)

Study arms

  • Experimental
    Teachers/student teachers with vocal fatigue

    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.

    Behavioral: Stress induction

  • Active comparator
    Control group

    Control participants without vocal fatigue based on Vocal Fatigue Index (VFI, German). Same experimental procedures as in arm 1.

    Behavioral: Stress induction

Interventions

  • BehavioralStress induction

    Induction of anticipatory stress to compare voice and speech control and production with and without exposure to stress.

06

What researchers measure

Primary outcomes

  1. Vocal fatigue

    Raw scores, Vocal Fatigue Index, VFI Factor 1

    Time frame: through study completion, an average of 1 month

  2. 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

    Time frame: through study completion, an average of 1 month

  3. Salivary cortisol

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

    Time frame: through study completion, an average of 1 month

  4. Suprahyoid muscle activity

    Suprahyoid muscle activity (RMS)

    Time frame: through study completion, an average of 1 month

  5. Infrahyoid muscle activity

    Infrahyoid muscle activity (RMS)

    Time frame: through study completion, an average of 1 month

  6. Personality, Social Potency

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

    Time frame: through study completion, an average of 1 month

  7. Personality, Stress Reaction

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

    Time frame: through study completion, an average of 1 month

  8. Personality, social anxiety

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

    Time frame: through study completion, an average of 1 month

Secondary outcomes

  1. Vocal fatigue

    Raw scores, Vocal Fatigue Index, VFI Factor 2 and 3

    Time frame: through study completion, an average of 1 month

  2. Voice quality of life

    Raw data, Voice Handicap Index, VHI

    Time frame: through study completion, an average of 1 month

  3. Vocal tract discomfort

    Raw data, Vocal Tract Discomfort Scale, VTD

    Time frame: through study completion, an average of 1 month

  4. Informal questionnaire on vocal health

    Raw data informal questionnaire on vocal health

    Time frame: through study completion, an average of 1 month

  5. 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

    Time frame: through study completion, an average of 1 month

  6. 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

    Time frame: through study completion, an average of 1 month

  7. 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

    Time frame: through study completion, an average of 1 month

  8. 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

    Time frame: through study completion, an average of 1 month

  9. 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

    Time frame: through study completion, an average of 1 month

  10. Personality, Wellbeing

    Personality trait Wellbeing (T-scores, Multidimensional Personality Questionnaire, MPQ)

    Time frame: through study completion, an average of 1 month

  11. Personality, Social Closeness

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

    Time frame: through study completion, an average of 1 month

  12. Personality, social anxiety

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

    Time frame: through study completion, an average of 1 month

  13. Personality, self-esteem

    Personality self-esteem (raw data, Rosenberg self-esteem scale)

    Time frame: through study completion, an average of 1 month

  14. Behavioral inhibition and exhibition

    Behavioral inhibition and exhibition (raw data, BIS/BAS scales, BIS subscale)

    Time frame: through study completion, an average of 1 month

  15. Chronic Stress

    Chronic stress (T-scores, Trier Inventory of Chronic Stress, TICS)

    Time frame: through study completion, an average of 1 month

  16. Handedness

    Handedness (raw data, Edinburgh Handedness Inventory, EHI)

    Time frame: through study completion, an average of 1 month

  17. State positive and negative affect

    State positive and negative affect (raw data, Positive and Negative Affect Schedule, PANAS)

    Time frame: through study completion, an average of 1 month

  18. Voice quality, relative fundamental frequency

    Voice quality, relative fundamental frequency (relative fundamental frequency, RFF in semitones \[ST\])

    Time frame: through study completion, an average of 1 month

  19. Voice quality, cepstral-spectral analysis

    Voice quality, cepstral-spectral analysis (cepstral peak prominence in dB)

    Time frame: through study completion, an average of 1 month

  20. Perceived vocal effort

    Perceived vocal effort (raw data, BORG-CR-10)

    Time frame: through study completion, an average of 1 month

  21. Cognitive effort

    Cognitive effort (raw data, NASA-TLX)

    Time frame: through study completion, an average of 1 month

07

Study locations

1 of 1 sites recruiting
08

References and documents

Individual participant data

Plan to share: 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.

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Aug 2023 (actual). Primary completion is estimated for Jun 2026, 34 months after the start.

Of 30 interventional studies with no phase under Voice Disorders, half reached primary completion within 37 months of starting (the median), counting those still running; a quarter within 8 and three quarters within 48. This study's planned 34 months is close to that.

How these figures are worked out, and which studies are left out of them.

Registered
Oct 19, 2023
First posted
Nov 13, 2023
StartActual
Aug 1, 2023
Primary completionEst.
Jun 30, 2026
CompletionEst.
Jul 31, 2026
Last update
Aug 27, 2025
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Aug 27, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06126627
Responsible party
Maria Dietrich (Research Associate, University Hospital, Bonn) — Principal investigator
First posted
Nov 13, 2023
Start date
Aug 1, 2023
Primary completion
Jun 30, 2026 (estimated)
Completion
Jul 31, 2026 (estimated)
Last update
Aug 27, 2025

Study contacts

Maria Dietrich, PhD
Contact
Maria.Dietrich@ukbonn.de
+49228287 ext. 11107
Lisa Sindermann, PhD
Contact
Lisa.Sindermann@ukbonn.de
+49228287 ext. 10465
Maria Dietrich, PhD
principal investigator · University Hospital, Bonn

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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