NCT06126627

Brief 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
3mo left

Started Aug 2023

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress92%
Aug 2023Jul 2026

Study Start

First participant enrolled

August 1, 2023

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

October 19, 2023

Completed
25 days until next milestone

First Posted

Study publicly available on registry

November 13, 2023

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2026

Expected
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2026

Last Updated

August 27, 2025

Status Verified

August 1, 2025

Enrollment Period

2.9 years

First QC Date

October 19, 2023

Last Update Submit

August 20, 2025

Conditions

Keywords

voice disordersvocal fatigueoccupational voice disordersstress reactivityvocal controllaryngeal motor cortexteachersspeech motor controlvoice motor control

Outcome Measures

Primary Outcomes (8)

  • Vocal fatigue

    Raw scores, Vocal Fatigue Index, VFI Factor 1

    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

    through study completion, an average of 1 month

  • Salivary cortisol

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

    through study completion, an average of 1 month

  • Suprahyoid muscle activity

    Suprahyoid muscle activity (RMS)

    through study completion, an average of 1 month

  • Infrahyoid muscle activity

    Infrahyoid muscle activity (RMS)

    through study completion, an average of 1 month

  • Personality, Social Potency

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

    through study completion, an average of 1 month

  • Personality, Stress Reaction

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

    through study completion, an average of 1 month

  • Personality, social anxiety

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

    through study completion, an average of 1 month

Secondary Outcomes (21)

  • Vocal fatigue

    through study completion, an average of 1 month

  • Voice quality of life

    through study completion, an average of 1 month

  • Vocal tract discomfort

    through study completion, an average of 1 month

  • Informal questionnaire on vocal health

    through study completion, an average of 1 month

  • BOLD MRI SMA

    through study completion, an average of 1 month

  • +16 more secondary outcomes

Study Arms (2)

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.

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.

Behavioral: Stress induction

Interventions

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

Control groupTeachers/student teachers with vocal fatigue

Eligibility Criteria

Age21 Years - 39 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital Bonn

Bonn, 53127, Germany

RECRUITING

MeSH Terms

Conditions

Voice Disorders

Condition Hierarchy (Ancestors)

Laryngeal DiseasesRespiratory Tract DiseasesOtorhinolaryngologic DiseasesNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Maria Dietrich, PhD

    University Hospital, Bonn

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Maria Dietrich, PhD

CONTACT

Lisa Sindermann, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research Associate

Study Record Dates

First Submitted

October 19, 2023

First Posted

November 13, 2023

Study Start

August 1, 2023

Primary Completion (Estimated)

June 30, 2026

Study Completion (Estimated)

July 31, 2026

Last Updated

August 27, 2025

Record last verified: 2025-08

Data Sharing

IPD Sharing
Will share

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.

Locations