Ignite Creation Date:
2024-06-16 @ 11:49 AM
Last Modification Date:
2024-10-26 @ 3:31 PM
Study NCT ID:
NCT06439290
Status:
RECRUITING
Last Update Posted:
2024-06-03
First Post:
2024-05-14
Brief Title:
Voice Outcome of Glottoplasty Cricothyroid Approximation Thyroplasty and Chondrolaryngoplasty
Sponsor:
University Ghent
Organization:
University Ghent
Study Overview
Official Title:
Voice Outcome of Glottoplasty Cricothyroid Approximation Thyroplasty and Chondrolaryngoplasty
Status:
RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
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 Adams 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 andor thyroid chondroplasty on a acoustic voice characteristics such as the pitch and resonance of the voice b perception of femininitymasculinity c psychosocial well-being and satisfaction and d the function of the vocal folds
Persons undergoing a glottoplasty cricothyroid approximation thyroplasty andor 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 eg 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
A thyroid chondroplasty is a procedure in which the cartilage of the larynx is flattened to make the larynx Adams 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 andor thyroid chondroplasty on a acoustic voice characteristics such as the pitch and resonance of the voice b perception of femininitymasculinity c psychosocial well-being and satisfaction and d the function of the vocal folds
Persons undergoing a glottoplasty cricothyroid approximation thyroplasty andor 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 eg 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None