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NCT Number: NCT06126627

Brain and Voice Signatures in 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.

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Key information

Conditions

Voice Disorders Laryngeal Diseases Nervous System Diseases Neurologic Manifestations Otorhinolaryngologic Diseases Pathological Conditions, Signs and Symptoms Respiratory Tract Diseases Signs and Symptoms Voice Fatigue

Age range

21 year–39 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

University Hospital Bonn

Bonn, 53127, Germany

Location status: Recruiting

Location contact

Maria Dietrich, PhD

CONTACT

[email protected]

+49228287 ext. 11107

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Stress Induction

Behavioral

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

Primary outcomes

  1. Vocal fatigue

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

    Raw scores, Vocal Fatigue Index, VFI Factor 1

  2. 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

  3. Salivary cortisol

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

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

  4. Suprahyoid muscle activity

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

    Suprahyoid muscle activity (RMS)

  5. Infrahyoid muscle activity

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

    Infrahyoid muscle activity (RMS)

  6. Personality, Social Potency

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

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

  7. Personality, Stress Reaction

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

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

  8. 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)

Secondary outcomes

  1. Vocal fatigue

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

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

  2. Voice quality of life

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

    Raw data, Voice Handicap Index, VHI

  3. Vocal tract discomfort

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

    Raw data, Vocal Tract Discomfort Scale, VTD

  4. Informal questionnaire on vocal health

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

    Raw data informal questionnaire on vocal health

  5. BOLD MRI SMA

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

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

  6. BOLD MRI ACC

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

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

  7. BOLD MRI MCC

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

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

  8. BOLD MRI Amygdala

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

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

  9. BOLD MRI PAG

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

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

  10. Personality, Wellbeing

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

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

  11. Personality, Social Closeness

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

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

  12. Personality, social anxiety

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

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

  13. Personality, self-esteem

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

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

  14. Behavioral inhibition and exhibition

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

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

  15. Chronic Stress

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

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

  16. Handedness

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

    Handedness (raw data, Edinburgh Handedness Inventory, EHI)

  17. State positive and negative affect

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

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

  18. Voice quality, relative fundamental frequency

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

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

  19. Voice quality, cepstral-spectral analysis

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

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

  20. Perceived vocal effort

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

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

  21. Cognitive effort

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

    Cognitive effort (raw data, NASA-TLX)

Study contacts

Contact information is provided by the study sponsor or research team.

Lisa Sindermann, PhD

CONTACT

[email protected]

+49228287 ext. 10465

Maria Dietrich, PhD

CONTACT

[email protected]

+49228287 ext. 11107

Sponsors and collaborators

Lead sponsor

University Hospital, Bonn

Other

Registry information

Official study title

Neurobiological and Psychobiological Signatures of Vocal Effort in Early Career Teachers

Acronym: BRAVO1

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Nov 13, 2023
Registry last updated
Aug 27, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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