Investigation of the Perceptual and Acoustic Voice in Trans Man

Gender Dysphoria Clinical Trial

Official title:

Investigation of the Perceptual and Acoustic Characteristic of Voice in Trans Man

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05166083
• Other study ID #: HUSLPTRANSMANVOICE
• Status: Recruiting
• Start date: March 11, 2022
• Est. completion date: May 2025

Study information

• Verified date: March 2024
• Source: Hacettepe University
• Contact: Fatma Esen AYDINLI, Assoc. Prof.
• Phone: +903123051093
• Email: fesen04[@]hacettepe.edu.tr
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

The aim of the study is to follow acoustic and perceptual voice changes in trans men during hormone therapy and to examine the relationship between psychosocial and vocal characteristics and testosterone measured in routine follow-up in accordance with international follow-up guidelines.

Description:

Trans men who have completed the evaluation and follow-up procedure and decided to use sex hormones will be included in the study. Participants will be followed for 8 doses of sex hormone use. Acoustic and perceptual changes in voice will be monitored at baseline (before hormone use), 4th dose, and 8th dose. The relationship between testosterone and psychosocial and vocal characteristics will be examined. At the baseline of the study, participants will be evaluated with Videolaryngostroboscopy (VLS). As a result of VLS, perceptual and acoustic voice evaluation will be made to the participants who are determined to have healthy vocal folds. During routine psychiatric visits, participants will be asked to fill in self-report scales. Endocrinological routine evaluations will be applied to the participants and the data of these routine evaluations will be used in the study. All of these evaluations (perceptual and acoustic voice evaluation, endocrinological and psychiatric evaluations) will be repeated at the 4. and 8. doses of the hormone therapy, except for the VLS evaluation.

IBM SPSS Statistics 26.0 and Microsoft Excel 365 programs will be used for statistical analysis. The number of participants to be included in the study was calculated using the G Power 3.1 program. In the analysis, the number of participants was determined as 28 (G power=0.80, α =0.05). The normal distribution of the data will be examined by visual and analytical methods (Shapiro-Wilk test, Kolmogorov-Smirnov test).The analysis of each variable measured at three time points will be evaluated using ANOVA if the assumptions of parametric tests are met, and using the Friedman test if the assumptions of parametric tests are not met. When the parametric conditions are met Paired t test will be used to compare the measurement values, and when the parametric conditions are not met, the Wilcoxon signed-rank test will be used. Multiple Regression Analysis will be used to determine the factors affecting the person's own perception of voince. Finally, statistical significance level was accepted as p<0.05.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 28
• Est. completion date: May 2025
• Est. primary completion date: January 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 60 Years

Eligibility

Inclusion Criteria:

• Being diagnosed with "Gender Dysphoria" according to DSM 5

• Having decided to start hormone therapy

Exclusion Criteria:

• Diagnosis of vocal fold lesion in videolaryngostroboscopy evaluation

• Having previously received voice therapy or undergone voice surgery

• Having a systematic/or neurological disorder that may affect voice quality

• Having had hormone therapy or still on hormone therapy

Related Conditions & MeSH terms

• Gender Dysphoria
• Hormone Replacement Therapy
• Transgender Persons
• Voice Disorder Due to Transsexualism
• Voice Disorders

Intervention

Other:
• Testosterone Hormon Therapy
Testosterone isocaproate, ... ml, 8 doses, once per 21 days

Locations

Country	Name	City	State
Turkey	Hacettepe University, Speech and Language Therapy	Ankara

Sponsors (1)

Lead Sponsor	Collaborator
Hacettepe University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Self-perception of voice	Transsexual Voice Questionnaire (TVQ-Female to male) Score Self-perception of voice masculinity (SPVM) Score	change from baseline to the 4th dose of hormone treatment
Primary	Change in Self-perception of voice	Transsexual Voice Questionnaire (TVQ-Female to male) Score Self-perception of voice masculinity (SPVM) Score	change from baseline to the 8th dose of hormone treatment
Primary	Change in Self-perception of voice	Transsexual Voice Questionnaire (TVQ-Female to male) Score Self-perception of voice masculinity (SPVM) Score	change from 4th to the 8th dose of hormone treatment
Secondary	Change in Acoustic Voice Characteristics	Digital recordings will be made using the Computerized Speech Lab (KayPENTAX) while performing the following tasks: sustained vowel /a:/, sponteous speech and "Pinokyo passage" reading. Voice recordings will be analyzed using the Real-Time Pitch Program and the Multidimensional Voice Program for measure F0, Mean F0, Jitter percent, Shimmer Percent, and noise-to-harmonic ratio (NHR).	change from baseline to the 4th dose of hormone treatment
Secondary	Change in Acoustic Voice Characteristics	Digital recordings will be made using the Computerized Speech Lab (KayPENTAX) while performing the following tasks: sustained vowel /a:/, sponteous speech and "Pinokyo passage" reading. Voice recordings will be analyzed using the Real-Time Pitch Program and the Multidimensional Voice Program for measure F0, Mean F0, Jitter percent, Shimmer Percent, and noise-to-harmonic ratio (NHR).	change from baseline to the 8th dose of hormone treatment
Secondary	Change in Acoustic Voice Characteristics	Digital recordings will be made using the Computerized Speech Lab (KayPENTAX) while performing the following tasks: sustained vowel /a:/, sponteous speech and "Pinokyo passage" reading. Voice recordings will be analyzed using the Real-Time Pitch Program and the Multidimensional Voice Program for measure F0, Mean F0, Jitter percent, Shimmer Percent, and noise-to-harmonic ratio (NHR).	change from 4th to the 8th dose of hormone treatment
Secondary	Changes in the person's severity of depression	- Beck depression inventory (BDI)	change from baseline to the 4th dose of hormone treatment
Secondary	Changes in the person's severity of depression	- Beck depression inventory (BDI)	change from baseline to the 8th dose of hormone treatment
Secondary	Changes in the person's severity of depression	- Beck depression inventory (BDI)	change from 4th to the 8th dose of hormone treatment
Secondary	Changes in the person's perception of support	- Multidimensional Scale of Perceived Social Support.	change from baseline to the 4th dose of hormone treatment
Secondary	Changes in the person's perception of support	- Multidimensional Scale of Perceived Social Support.	change from baseline to the 8th dose of hormone treatment
Secondary	Changes in the person's perception of support	- Multidimensional Scale of Perceived Social Support.	change from 4th to the 8th dose of hormone treatment
Secondary	Changes in the person's anxiety level	- State-trait anxiety Inventory	change from baseline to the 4th dose of hormone treatment
Secondary	Changes in the person's anxiety level	- State-trait anxiety Inventory	change from baseline to the 8th dose of hormone treatment
Secondary	Changes in the person's anxiety level	- State-trait anxiety Inventory	change from 4th to the 8th dose of hormone treatment
Secondary	Changes in the person's gender perception and gender transition process	- Transition questionnaire: The Transition Questionnaire is a self-report instrument that collects information on an individual's self-perception of status about the social and medical steps in the process of gender transition.	change from baseline to the 4th dose of hormone treatment
Secondary	Changes in the person's gender perception and gender transition process	- Transition questionnaire: The Transition Questionnaire is a self-report instrument that collects information on an individual's self-perception of status about the social and medical steps in the process of gender transition.	change from baseline to the 8th dose of hormone treatment
Secondary	Changes in the person's gender perception and gender transition process	- Transition questionnaire: The Transition Questionnaire is a self-report instrument that collects information on an individual's self-perception of status about the social and medical steps in the process of gender transition.	change from 4th to the 8th dose of hormone treatment
Secondary	Changes in the person's body image perception	-Body cathexis scale	change from baseline to the 4th dose of hormone treatment
Secondary	Changes in the person's body image perception	-Body cathexis scale	change from baseline to the 8th dose of hormone treatment
Secondary	Changes in the person's body image perception	-Body cathexis scale	change from 4th to the 8th dose of hormone treatment
Secondary	Change in testosterone level	Testosterone level measurement	change from baseline to the 4th dose of hormone treatment
Secondary	Change in testosterone level	Testosterone level measurement	change from baseline to the 8th dose of hormone treatment
Secondary	Change in testosterone level	Testosterone level measurement	change from 4th to the 8th dose of hormone treatment