SurgeryNCT06439290
Voice Outcome of Glottoplasty, Cricothyroid Approximation, Thyroplasty, and Chondrolaryngoplasty
A study testing Phonosurgery and Mastectomy/breast augmentation in people with Surgery and Larynx, run by University Ghent at 2 sites in Belgium.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Surgery, Larynx, Transgenderism
- What is being tested?
- Phonosurgery and Mastectomy/breast augmentation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 290 participants
- Where
- 2 sitesBelgium
- Study dates
- 10 Apr 2024to Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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:
Show all 12Show fewer
- Dutch-speaking
- Self-reported normal hearing
- PURPOSE 2: same as above.
- PURPOSE 3:
- At least 18 years old
- Sufficient command of the Dutch language to complete a Dutch questionnaire
Who cannot join
- 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 locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Belgium2 sites, 2 recruiting
- Recruiting
Ghent University Hospital
Ghent, East-Flanders, 9000
Clara Leyns, PhD, clara.leyns@ugent.be
- Recruiting
Ghent University
Ghent, East-Flanders, 9000
Clara Leyns, PhD, clara.leyns@ugent.be
About this study
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.
Read the detailed description
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.
- Conditions
- Surgery, Larynx, Transgenderism, Gender Dysphoria
- Being tested
- Phonosurgery, Mastectomy/breast augmentation
- Keywords
- Transgender, Phonosurgery, Determinants, MRI
- Medical subject headings
- Laryngeal Diseases, Transsexualism, Gender Dysphoria
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PhonosurgeryProcedure or surgery
Also called glottoplasty, thyroplasty, cricothyroid approximation, chondrolaryngoplasty
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 augmentationProcedure or surgery
Control group of PFAB and PMAB persons undergoing a mastectomy or breast augmentation surgery.
| Study group | Role | What they receive |
|---|---|---|
| Experimental group: phonosurgery | Experimental | Group undergoing phonosurgery (glottoplasty, cricothyroid approximation, thyroplasty or chondrolaryngoplasty) Receives: Procedure: Phonosurgery |
| Control group: other surgery | Active comparator | Control group: age matched TGD PFAB/PMAB undergoing mastectomy or breast augmentation surgery with the same in- and exclusion criteria. Receives: Procedure: Mastectomy/breast augmentation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Speaking fo
Speaking fundamental frequency
Measured: pre, post 1 (1 week), post 2 (1 month), post 3 (6 months), post 4 (1 year)
FF 1-5
Formant frequencies 1-5
Measured: pre, post 1 (1 week), post 2 (1 month), post 3 (6 months), post 4 (1 year)
Perceptual femininity/masculinity score
Self-perception and listener perceptions of femininity and masculinity. Visual analogue scale (0 = very masculine, 100 = very feminine).
Measured: pre, post 1 (1 week), post 2 (1 month), post 3 (6 months), post 4 (1 year)
Secondary outcomes (7)
Vocal capacity
Dysphonia Severity Index, cut-off score 1.6 (above 1.6 is normophonic)
Measured: pre, post 1 (1 week), post 2 (1 month), post 3 (6 months), post 4 (1 year)
Vocal range
Voice Range Profile (min-max of fo and intensity (SPL))
Measured: pre, post 1 (1 week), post 2 (1 month), post 3 (6 months), post 4 (1 year)
Vocal quality
Acoustic Voice Quality Index, cut-off score 2.95 (below 2.95 is normophonic)
Measured: pre, post 1 (1 week), post 2 (1 month), post 3 (6 months), post 4 (1 year)
Laryngeal function
Flexible videolaryngostroboscopy
Measured: pre, post 1 (1 week), post 2 (1 month), post 3 (6 months), post 4 (1 year)
PROMs: Voice Handicap Index
Voice Handicap Index, score from 0-120, the higher the score, the worse.
Measured: pre, post 1 (1 week), post 2 (1 month), post 3 (6 months), post 4 (1 year)
PROMs: Trans Woman Voice Questionnaire
Trans Woman Voice Questionnaire, score from 1-120, the higher the score, the worse.
Measured: pre, post 1 (1 week), post 2 (1 month), post 3 (6 months), post 4 (1 year)
Other PROMs
Visual analogue scales to measure satisfaction (VAS with 0=strongly disagree, 100=strongly agree).
Measured: pre, post 1 (1 week), post 2 (1 month), post 3 (6 months), post 4 (1 year)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2024
- Study start10 Apr 2024
- Primary completionDec 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SurgeryStudies of the same condition, open and under way.
- More trials run by University GhentThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Purpose 1: prospective non-randomized controlled trial. Experimental group: persons undergoing phonosurgery Control group: age-matched PFAB/PMAB undergoing mastectomy/breast augmentation Purpose 2: Predictors of the outcome of abovementioned surgery in the experimental group will be determined using correlational research (regression analysis). Purpose 3: After optimization of MRI sequences and testing in healthy participants (n=5), a segmentation and measurement workflow will be completed. Objective measurement of pre- and postoperative laryngeal anatomy: Anatomical outcome measures will be obtained and compared before and one month/6 months after surgery in the experimental group.
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 290 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Ghent
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Clara Leyns, PhD, Study director, University GhentEvelien D'haeseleer, PhD, Principal investigator, University GhentPeter Tomassen, PhD, MD, Principal investigator, University Hospital, Ghent
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06439290
- Sponsor's protocol ID
- ONZ-2024-0049/ONZ-2024-0081
- Status last verified
- May 2024
- First submitted
- 14 May 2024
- Last updated
- 3 Jun 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Voice Outcome of Glottoplasty, Cricothyroid Approximation, Thyroplasty, and Chondrolaryngoplasty
- ClinicalTrials.gov ID
- NCT06439290
- Acronym / sponsor ID
- ONZ-2024-0049/ONZ-2024-0081
- Conditions
- Surgery, Larynx, Transgenderism, Gender Dysphoria
- Keywords
- Transgender, Phonosurgery, Determinants, MRI
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 290 participants (estimated)
- Lead sponsor
- University GhentUniversity, hospital or other
- Study start
- 10 Apr 2024 (actual)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 3 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (care provider)
- Number of arms
- 2
- Model description
- Purpose 1: prospective non-randomized controlled trial. Experimental group: persons undergoing phonosurgery Control group: age-matched PFAB/PMAB undergoing mastectomy/breast augmentation Purpose 2: Predictors of the outcome of abovementioned surgery in the experimental group will be determined using correlational research (regression analysis). Purpose 3: After optimization of MRI sequences and testing in healthy participants (n=5), a segmentation and measurement workflow will be completed. Objective measurement of pre- and postoperative laryngeal anatomy: Anatomical outcome measures will be obtained and compared before and one month/6 months after surgery in the experimental group.
| Arm | Type | Receives |
|---|---|---|
| Experimental group: phonosurgery | Experimental | Procedure: PhonosurgeryGroup undergoing phonosurgery (glottoplasty, cricothyroid approximation, thyroplasty or chondrolaryngoplasty) |
| Control group: other surgery | Active comparator | Procedure: Mastectomy/breast augmentationControl group: age matched TGD PFAB/PMAB undergoing mastectomy or breast augmentation surgery with the same in- and exclusion criteria. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- 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
- Cisgender men or women
- Dutch-speaking
Key exclusion criteria (5 listed)
- One or more contraindications for an MRI examination. These contraindications are checked using a questionnaire (safety checklist).
- Random selection of +- 10 participants of purpose 1.
- One or more contraindications for an MRI examination. These contraindications are checked using a questionnaire (safety checklist).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PhonosurgeryAlso: glottoplasty, thyroplasty, cricothyroid approximation, chondrolaryngoplastyGender-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. | Procedure or surgery | Experimental group: phonosurgery |
| Mastectomy/breast augmentationControl group of PFAB and PMAB persons undergoing a mastectomy or breast augmentation surgery. | Procedure or surgery | Control group: other surgery |
Primary outcome
Speaking fo
Time frame: pre, post 1 (1 week), post 2 (1 month), post 3 (6 months), post 4 (1 year)
Speaking fundamental frequency
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
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).
7 secondary outcomes
Vocal capacity
Time frame: pre, post 1 (1 week), post 2 (1 month), post 3 (6 months), post 4 (1 year)
Vocal range
Time frame: pre, post 1 (1 week), post 2 (1 month), post 3 (6 months), post 4 (1 year)
Vocal quality
Time frame: pre, post 1 (1 week), post 2 (1 month), post 3 (6 months), post 4 (1 year)
Laryngeal function
Time frame: pre, post 1 (1 week), post 2 (1 month), post 3 (6 months), post 4 (1 year)
PROMs: Voice Handicap Index
Time frame: pre, post 1 (1 week), post 2 (1 month), post 3 (6 months), post 4 (1 year)
PROMs: Trans Woman Voice Questionnaire
Time frame: pre, post 1 (1 week), post 2 (1 month), post 3 (6 months), post 4 (1 year)
Other PROMs
Time frame: pre, post 1 (1 week), post 2 (1 month), post 3 (6 months), post 4 (1 year)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jun 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Clara Leyns, PhD study director
University Ghent
Evelien D'haeseleer, PhD principal investigator
University Ghent
Peter Tomassen, PhD, MD principal investigator
University Hospital, Ghent
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Phonosurgery and Mastectomy/breast augmentation in people with Surgery and Larynx, run by University Ghent at 2 sites in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 3 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Evelien D'haeseleer, PhD (+32 9 332 24 67, evelien.dhaeseleer@ugent.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Speaking fo (time frame: pre, post 1 (1 week), post 2 (1 month), post 3 (6 months), post 4 (1 year)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jun 2024.