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Brain and Voice Signatures in Teachers (BRAVO1)

U

University Hospital Bonn (UKB)

Status

Enrolling

Conditions

Voice Disorders
Voice Fatigue

Treatments

Behavioral: Stress induction

Study type

Interventional

Funder types

Other

Identifiers

NCT06126627
R01DC018026 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Enrollment

100 estimated patients

Sex

Female

Ages

21 to 39 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Basic Science

Allocation

Non-Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

100 participants in 2 patient groups

Teachers/student teachers with vocal fatigue
Experimental group
Description:
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.
Treatment:
Behavioral: Stress induction
Control group
Active Comparator group
Description:
Control participants without vocal fatigue based on Vocal Fatigue Index (VFI, German). Same experimental procedures as in arm 1.
Treatment:
Behavioral: Stress induction

Trial contacts and locations

1

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Central trial contact

Lisa Sindermann, PhD; Maria Dietrich, PhD

Data sourced from clinicaltrials.gov

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