Voice Outcome of Glottoplasty, Cricothyroid Approximation, Thyroplasty, and Chondrolaryngoplasty
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-70
SponsorUniversity Ghent
About this trial
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 criteria
This trial accepts healthy volunteersQualifiers
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
Dutch-speaking
Disqualifiers
None
Trial design
Design model
Parallel
Treatments tested in this trial
Phonosurgery
Procedure/SurgeryGender-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
Procedure/SurgeryControl group of PFAB and PMAB persons undergoing a mastectomy or breast augmentation surgery.
Treatment groups
290 Participants
are divided into 2 treatment groupsGroup A: Experimental group: phonosurgeryExperimental treatment 1 intervention
Group B: Control group: other surgeryActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Speaking fo
Speaking fundamental frequency
Time frame
pre, post 1 (1 week), post 2 (1 month), post 3 (6 months), post 4 (1 year)2
FF 1-5
Formant frequencies 1-5
Time frame
pre, post 1 (1 week), post 2 (1 month), post 3 (6 months), post 4 (1 year)3
Perceptual femininity/masculinity score
Self-perception and listener perceptions of femininity and masculinity. Visual analogue scale (0 = very masculine, 100 = very feminine).
Time frame
pre, post 1 (1 week), post 2 (1 month), post 3 (6 months), post 4 (1 year)Secondary outcomes
1
Vocal capacity
Dysphonia Severity Index, cut-off score 1.6 (above 1.6 is normophonic)
Time frame
pre, post 1 (1 week), post 2 (1 month), post 3 (6 months), post 4 (1 year)2
Vocal range
Voice Range Profile (min-max of fo and intensity (SPL))
Time frame
pre, post 1 (1 week), post 2 (1 month), post 3 (6 months), post 4 (1 year)3
Vocal quality
Acoustic Voice Quality Index, cut-off score 2.95 (below 2.95 is normophonic)
Time frame
pre, post 1 (1 week), post 2 (1 month), post 3 (6 months), post 4 (1 year)4
Laryngeal function
Flexible videolaryngostroboscopy
Time frame
pre, post 1 (1 week), post 2 (1 month), post 3 (6 months), post 4 (1 year)Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov