Trials
Search / Trial NCT06439290

Voice Outcome of Glottoplasty, Cricothyroid Approximation, Thyroplasty, and Chondrolaryngoplasty

Launched by UNIVERSITY GHENT · May 30, 2024

Trial Information

Current as of February 19, 2025

Recruiting

Keywords

Transgender Phonosurgery Determinants Mri

ClinConnect Summary

This clinical trial is studying how different surgical procedures, such as glottoplasty and thyroplasty, affect voice outcomes for individuals preparing for these surgeries. The main goal is to understand both the short-term and long-term changes in voice quality after surgery and to find out what factors might influence these outcomes. Researchers will also use advanced imaging techniques to examine the structure of the larynx (the voice box) before and after surgery to see how these changes relate to the voice improvements.

To be eligible for this study, participants must be at least 18 years old and planning to undergo one of the mentioned surgeries at UZ Gent. They should also be able to understand Dutch well enough to complete questionnaires. The study is currently looking for both surgery patients and healthy volunteers who can help provide speech samples or listen to recordings for analysis. Participants can expect to undergo voice assessments and possibly MRI scans to gather detailed information about their laryngeal anatomy before and after surgery. This research aims to improve care for individuals with gender dysphoria and other conditions that affect the voice.

Gender

ALL

Eligibility criteria

  • PURPOSE 1:
  • Inclusion criteria for surgery participants:
  • Persons who will soon undergo surgery on the vocal folds and/or larynx (including glottoplasty, cricothyroid approximation, thyroplasty and/or thyroid chondroplasty) at UZ Gent
  • At least 18 years old
  • Sufficient command of the Dutch language for understanding the informed consent letter and completing Dutch questionnaires
  • Inclusion criteria for volunteers to provide speech samples:
  • - Cisgender men or women
  • Inclusion criteria for volunteer listeners for the listening experiment:
  • Dutch-speaking
  • Self-reported normal hearing
  • PURPOSE 2: same as above.
  • PURPOSE 3:
  • Inclusion criteria for the healthy participants:
  • At least 18 years old
  • Sufficient command of the Dutch language to complete a Dutch questionnaire
  • Exclusion criteria for the healthy participants:
  • - One or more contraindications for an MRI examination. These contraindications are checked using a questionnaire (safety checklist).
  • Inclusion criteria for the pre- and postoperative MRI participants:
  • - Random selection of +- 10 participants of purpose 1.
  • Exclusion criteria for the pre- and postoperative MRI participants:
  • - One or more contraindications for an MRI examination. These contraindications are checked using a questionnaire (safety checklist).

Trial Officials

Clara Leyns, PhD

Study Director

University Ghent

Evelien D'haeseleer, PhD

Principal Investigator

University Ghent

Peter Tomassen, PhD, MD

Principal Investigator

University Hospital, Ghent

About University Ghent

University Ghent is a prestigious Belgian research institution renowned for its commitment to advancing medical science and improving patient care through innovative clinical trials. With a multidisciplinary approach, the university fosters collaboration among leading experts in various fields, ensuring rigorous study design and ethical standards. University Ghent is dedicated to exploring new therapeutic modalities and enhancing healthcare outcomes, making significant contributions to both local and global health landscapes. Its state-of-the-art facilities and emphasis on research excellence position it as a pivotal sponsor in the realm of clinical research.

Locations

Ghent, East Flanders, Belgium

Ghent, East Flanders, Belgium

People applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

Discussion 0