NCT04708600

Brief Summary

One of the greatest hurdles in the transition of transgender persons is that voice, speech and communication are not congruent with the desired gender. Since hormone treatment does not affect the voice in male-to-female transgender persons (trans women), speech therapy is the treatment of choice to develop a more feminine communication. Speech therapy must focus on aspects of communication that play an important role in listener perceptions of the speakers gender. Results of a systematic review and meta-analysis showed that those aspects are primarily fundamental frequency of the voice and resonance. However, effectiveness studies of speech interventions in transwomen are extremely limited and show methodological limitations. The purpose of this project is to investigate the short-term and longterm impact of speech exercises for pitch and resonance on (a) acoustic voice characteristics, (b) listener perceptions of femininity using a visual analogue scale and binary gender identification (male versus female voice), and (c) self-perception and psychosocial functioning in trans women using a randomized sham-controlled trial and cross-over design.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
78

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2019

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2019

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

September 14, 2020

Completed
4 months until next milestone

First Posted

Study publicly available on registry

January 14, 2021

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 30, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 30, 2023

Completed
Last Updated

December 13, 2023

Status Verified

December 1, 2023

Enrollment Period

3.6 years

First QC Date

September 14, 2020

Last Update Submit

December 12, 2023

Conditions

Outcome Measures

Primary Outcomes (4)

  • Acoustics: change in speaking fundamental frequency

    Median Speaking fo, fo upper limit (pc95), fo lower limit (pc25)

    pre, post 1 (immediately after sham), post 2 (immediately after intervention 1), post 3 (immediately after intervention 2), follow-up 1 (after 3 months), follow-up 2 (after 1 year)

  • Acoustics: change in formant frequencies

    Median Formant Frequencies F1-F5 of the vowels /a/, /i/, /u/

    pre, post 1 (immediately after sham), post 2 (immediately after intervention 1), post 3 (immediately after intervention 2), follow-up 1 (after 3 months), follow-up 2 (after 1 year)

  • Change in listeners perceptions

    masculinity/femininity ratings (using a VAS) and gender identification

    pre, post 1 (immediately after sham), post 2 (immediately after intervention 1), post 3 (immediately after intervention 2), follow-up 1 (after 3 months), follow-up 2 (after 1 year)

  • Change in self-assessment

    Trans women voice questionnaire

    pre, post 1 (immediately after sham), post 2 (immediately after intervention 1), post 3 (immediately after intervention 2), follow-up 1 (after 3 months), follow-up 2 (after 1 year)

Secondary Outcomes (3)

  • Change in Dysphonia Severity Index

    pre, post 1 (immediately after sham), post 2 (immediately after intervention 1), post 3 (immediately after intervention 2), follow-up 1 (after 3 months), follow-up 2 (after 1 year)

  • Change in Acoustic Voice Quality Index

    pre, post 1 (immediately after sham), post 2 (immediately after intervention 1), post 3 (immediately after intervention 2), follow-up 1 (after 3 months), follow-up 2 (after 1 year)

  • Change in Voice Range Profile

    pre, post 1 (immediately after sham), post 2 (immediately after intervention 1), post 3 (immediately after intervention 2), follow-up 1 (after 3 months), follow-up 2 (after 1 year)

Study Arms (2)

Group 1

EXPERIMENTAL

Sham therapy Intervention 1: PET Intervention 2: ART

Behavioral: Pitch Elevation TherapyBehavioral: Articulation Resonance TherapyBehavioral: Sham therapy

Group 2

EXPERIMENTAL

Sham therapy Intervention 1: ART Intervention 2: PET

Behavioral: Pitch Elevation TherapyBehavioral: Articulation Resonance TherapyBehavioral: Sham therapy

Interventions

Goal: mean fundamental frequency of 180Hz (range 140 and 300Hz); Doses and duration: 5 one hour sessions (5h), 5 weeks Content: * auditory discrimination of lower and higher tones * pitch glides * pitch glides using straw phonation and resonance tube phonation * practice of higher pitch voice (target: 180Hz) in isolated vowels - syllables - mono and bisyllabic words -phrases - sentences and texts - conversation (generalization to spontaneous speech)

Also known as: PET
Group 1Group 2

Goal: increase in lipspreading, forward tongue carriage, larynx elevation, forward resonance, precise articulation; 5 sessions Doses and duration: 5 one hour sessions (5h), 5 weeks Content: * auditory and visual discrimination of forward vs backed tongue carriage and lip spreading vs lip rounding) * practice of technique on isolated vowels -syllables -mono and bisyllabic words - phrases - sentences and texts - conversation (generalization to spontaneous speech) * practising larynx elevation through the twang technique, isolated vowels -syllables -mono and bisyllabic words - phrases - sentences and texts - conversation (generalization to spontaneous speech) * forward resonance, focusing on oral forward resonance rather than chest resonance, isolated vowels -syllables -mono and bisyllabic words - phrases - sentences and texts - conversation (generalization to spontaneous speech) * clear, precise articulation and cork exercise

Also known as: ART
Group 1Group 2
Sham therapyBEHAVIORAL

Goal: active sham treatment, 4 sessions Doses and duration: 4 one hour and 15 minutes sessions (5h), 4 weeks Content: * providing information about vocal function, vocal surgery, vocal hygiene, transgender health care * discussing communication aspects and patterns, possible exercise contexts, communication partners, expectations of voice modification, conversational subjects * active intervention on nonverbal communication (Kinesics, gestures and sign language, facial expression, haptics, proxemics, occulsics, and physical appearance) * practising costo abdominal breathing patterns

Group 1Group 2

Eligibility Criteria

Age18 Years - 70 Years
Sexmale(Gender-based eligibility)
Gender Eligibility DetailsStudy population are trans women or AMAB (assigned male at birth). Inclusion criteria are established diagnose and gender identity confirmed by the gender team, under hormonal treatment (confirmed by blood analysis), female gender role, perceived as male speaker at the beginning of the therapy by the investigators and speaking fo within the male or ambiguous zone (\<180Hz).
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • established diagnose and gender identity confirmed by the gender team,
  • aged between 18 and 70 years,
  • self-reported normal hearing,
  • native Dutch speaker,
  • under hormonal treatment (confirmed by blood analysis),
  • female gender role, perceived as male speaker at the beginning of the therapy by the investigators
  • speaking fo within the male or ambiguous zone (\<180Hz).

You may not qualify if:

  • history of neurological disorders, previous phonosurgery or speech therapy
  • pathology of the vocal folds (observed by videolaryngostroboscopic examination of the vocal cords),
  • smokers.
  • to form a homogeneous study population gender non-binary persons will not be included in this study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Evelien D'haeseleer

Ghent, 9000, Belgium

Location

Related Publications (6)

  • Gelfer MP, Tice RM. Perceptual and acoustic outcomes of voice therapy for male-to-female transgender individuals immediately after therapy and 15 months later. J Voice. 2013 May;27(3):335-47. doi: 10.1016/j.jvoice.2012.07.009. Epub 2012 Oct 22.

    PMID: 23084812BACKGROUND
  • Dacakis G. Long-term maintenance of fundamental frequency increases in male-to-female transsexuals. J Voice. 2000 Dec;14(4):549-56. doi: 10.1016/s0892-1997(00)80010-7.

    PMID: 11130111BACKGROUND
  • Leung Y, Oates J, Chan SP. Voice, Articulation, and Prosody Contribute to Listener Perceptions of Speaker Gender: A Systematic Review and Meta-Analysis. J Speech Lang Hear Res. 2018 Feb 15;61(2):266-297. doi: 10.1044/2017_JSLHR-S-17-0067.

    PMID: 29392290BACKGROUND
  • Gelfer MP, Mikos VA. The relative contributions of speaking fundamental frequency and formant frequencies to gender identification based on isolated vowels. J Voice. 2005 Dec;19(4):544-54. doi: 10.1016/j.jvoice.2004.10.006.

    PMID: 16301101BACKGROUND
  • Carew L, Dacakis G, Oates J. The effectiveness of oral resonance therapy on the perception of femininity of voice in male-to-female transsexuals. J Voice. 2007 Sep;21(5):591-603. doi: 10.1016/j.jvoice.2006.05.005. Epub 2006 Jul 5.

    PMID: 16822646BACKGROUND
  • Soderpalm E, Larsson A, Almquist SA. Evaluation of a consecutive group of transsexual individuals referred for vocal intervention in the west of Sweden. Logoped Phoniatr Vocol. 2004;29(1):18-30. doi: 10.1080/14015430310021618.

    PMID: 15089001BACKGROUND

MeSH Terms

Conditions

TranssexualismGender DysphoriaCommunication Disorders

Condition Hierarchy (Ancestors)

SexualitySexual BehaviorBehaviorSexual Dysfunctions, PsychologicalMental DisordersNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsNeurodevelopmental Disorders

Study Officials

  • Evelien D'haeseleer, PhD

    University Ghent

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 14, 2020

First Posted

January 14, 2021

Study Start

September 1, 2019

Primary Completion

March 30, 2023

Study Completion

March 30, 2023

Last Updated

December 13, 2023

Record last verified: 2023-12

Data Sharing

IPD Sharing
Will not share

Locations