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Clinical Trials in Belgium / NCT06439290
Recruiting Not applicable

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

NCT06439290 · tracked via the Priya Life Science Belgium tracker
Phase
Not applicable
Started
2024-04-10
Last updated
2024-06-03

Condition(s) studied

SurgeryLarynxTransgenderismGender Dysphoria

Investigational drug(s) / intervention(s)

PhonosurgeryMastectomy/breast augmentation

Phonosurgery: Gender-affirming voice surgery (such as glottoplasty, cricothyroid approximation, thyroplasty and chondrolaryngoplasty), in addition to gender-affirming voice training and hormone therapy, plays an important role in achieving a gender-congruent voice in transgender and gender diverse people. In addition, these interventions are sometimes performed on cisgender men or women who wish to change their voice. However, the impact of these interventions on broad voice characteristics needs to be further investigated.

Mastectomy/breast augmentation: Control group of PFAB and PMAB persons undergoing a mastectomy or breast augmentation surgery.

Study summary

The purpose of this study is to measure the short- and long-term voice outcome and outcome predictors of glottoplasty, cricothyroid approximation, thyroplasty, and chondrolaryngoplasty using a prospective non-randomized controlled trial and a multidimensional voice assessment protocol. Secondly, a laryngeal magnetic resonance imaging protocol will be developed to measure pre- and postoperative anatomical factors and compare them with the acoustic changes.

Eligibility

Sex
ALL
Min age
18 Years
Max age
70 Years
Healthy volunteers
Accepted
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).

Primary outcome measure(s)

Trial sites (2)

FacilityCityRegionStatus
Ghent University Hospital Ghent East-Flanders Recruiting
Ghent University Ghent East-Flanders Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06439290 on ClinicalTrials.gov ↗ ← All trials in Belgium