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NCT Number: NCT06439290

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

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.

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Key information

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ghent University, Ghent, East-Flanders, Belgium

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About this study

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.

A thyroid chondroplasty is a procedure in which the cartilage of the larynx is flattened to make the larynx ("Adam's apple") less visible. This procedure is sometimes performed in combination with voice surgery. Although clinically in some cases we observe a temporary lowering of the pitch of the voice during thyroid chondroplasty, little is known in the literature about the impact of this surgery on voice characteristics.

The first purpose is to measure the effect of glottoplasty, cricothyroid approximation, thyroplasty and/or thyroid chondroplasty on a) acoustic voice characteristics (such as the pitch and resonance of the voice), b) perception of femininity/masculinity, c) psychosocial well-being and satisfaction and d) the function of the vocal folds.

Persons undergoing a glottoplasty, cricothyroid approximation, thyroplasty and/or thyroid chondroplasty in the head and neck surgery department are routinely invited to several pre- and postoperative check-up appointments in the head and neck surgery and ear, nose and throat department. These people will be invited to participate in the study in which the data, which are routinely collected preoperatively, 1 week, 1 month, 6 months and 12 months postoperatively during a speech-language pathology (SLP) consultation and a head and neck surgery consultation. These data will be used for scientific research to study the outcome of such surgery on phonation. These pre- and post-operative consultations are clinically standard. During these consultations, a voice assessment and videolaryngostroboscopic examination of the vocal folds are routinely performed.

Recordings and images obtained through these studies can be further processed in the context of this scientific research (such as conducting a listening experiment, analyzing (e.g. using the VALI form) and measuring the video laryngostroboscopy results, etc.).

Secondly, factors (determinants) that influence the effect of previous surgical interventions will be studied within this research.

The third purpose of this study is to develop and validate a laryngeal magnetic resonance imaging (MRI) protocol using a laryngeal surface coil to measure pre- and postoperative anatomical factors (vocal fold length and thickness, thyroarytenoid muscle mass and area) and compare them with the acoustic changes.

Who can participate

Healthy volunteers accepted: Yes

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

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).

Treatment and study plan

Phonosurgery

Procedure

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.

Other names: glottoplasty, thyroplasty, cricothyroid approximation, chondrolaryngoplasty

Mastectomy/breast augmentation

Procedure

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

Primary outcomes

  1. Speaking fo

    Time frame: pre, post 1 (1 week), post 2 (1 month), post 3 (6 months), post 4 (1 year)

    Speaking fundamental frequency

  2. FF 1-5

    Time frame: pre, post 1 (1 week), post 2 (1 month), post 3 (6 months), post 4 (1 year)

    Formant frequencies 1-5

  3. Perceptual femininity/masculinity score

    Time frame: pre, post 1 (1 week), post 2 (1 month), post 3 (6 months), post 4 (1 year)

    Self-perception and listener perceptions of femininity and masculinity. Visual analogue scale (0 = very masculine, 100 = very feminine).

Secondary outcomes

  1. Vocal capacity

    Time frame: pre, post 1 (1 week), post 2 (1 month), post 3 (6 months), post 4 (1 year)

    Dysphonia Severity Index, cut-off score 1.6 (above 1.6 is normophonic)

  2. Vocal range

    Time frame: pre, post 1 (1 week), post 2 (1 month), post 3 (6 months), post 4 (1 year)

    Voice Range Profile (min-max of fo and intensity (SPL))

  3. Vocal quality

    Time frame: pre, post 1 (1 week), post 2 (1 month), post 3 (6 months), post 4 (1 year)

    Acoustic Voice Quality Index, cut-off score 2.95 (below 2.95 is normophonic)

  4. Laryngeal function

    Time frame: pre, post 1 (1 week), post 2 (1 month), post 3 (6 months), post 4 (1 year)

    Flexible videolaryngostroboscopy

  5. PROMs: Voice Handicap Index

    Time frame: pre, post 1 (1 week), post 2 (1 month), post 3 (6 months), post 4 (1 year)

    Voice Handicap Index, score from 0-120, the higher the score, the worse.

  6. PROMs: Trans Woman Voice Questionnaire

    Time frame: pre, post 1 (1 week), post 2 (1 month), post 3 (6 months), post 4 (1 year)

    Trans Woman Voice Questionnaire, score from 1-120, the higher the score, the worse.

  7. Other PROMs

    Time frame: pre, post 1 (1 week), post 2 (1 month), post 3 (6 months), post 4 (1 year)

    Visual analogue scales to measure satisfaction (VAS with 0=strongly disagree, 100=strongly agree).

Study contacts

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

Clara Leyns, PhD

CONTACT

[email protected]

+3293320143

Evelien D'haeseleer, PhD

CONTACT

[email protected]

+32 9 332 24 67

Sponsors and collaborators

Lead sponsor

University Ghent

Other

Registry information

Important dates

Study start
2024
Primary completion
2027
Study completion
2027
First posted
Jun 3, 2024
Registry last updated
Jun 3, 2024

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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