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Effectiveness of Speech Therapy in Trans Women.

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ClinicalTrials.gov Identifier: NCT04708600
Recruitment Status : Recruiting
First Posted : January 14, 2021
Last Update Posted : January 14, 2021
Sponsor:
Information provided by (Responsible Party):
University Ghent

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 of Leung et al. (2018) 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.

Condition or disease Intervention/treatment Phase
Transgenderism Gender Dysphoria Speech Therapy Voice Disorder Due to Transsexualism Behavioral: Pitch Elevation Therapy Behavioral: Articulation Resonance Therapy Behavioral: Sham therapy Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 78 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effectiveness of Speech Therapy in Trans Women.
Actual Study Start Date : September 1, 2019
Estimated Primary Completion Date : September 30, 2023
Estimated Study Completion Date : January 30, 2024

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Group 1
Sham therapy Intervention 1: PET Intervention 2: ART
Behavioral: Pitch Elevation Therapy

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)
Other Name: PET

Behavioral: Articulation Resonance Therapy

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
Other Name: ART

Behavioral: Sham therapy

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

Experimental: Group 2
Sham therapy Intervention 1: ART Intervention 2: PET
Behavioral: Pitch Elevation Therapy

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)
Other Name: PET

Behavioral: Articulation Resonance Therapy

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
Other Name: ART

Behavioral: Sham therapy

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




Primary Outcome Measures :
  1. Acoustics: change in speaking fundamental frequency [ Time Frame: 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) ]
    Median Speaking fo, fo upper limit (pc95), fo lower limit (pc25)

  2. Acoustics: change in formant frequencies [ Time Frame: 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) ]
    Median Formant Frequencies F1-F5 of the vowels /a/, /i/, /u/

  3. Change in listeners perceptions [ Time Frame: 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) ]
    masculinity/femininity ratings (using a VAS) and gender identification

  4. Change in self-assessment [ Time Frame: 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) ]
    Trans women voice questionnaire


Secondary Outcome Measures :
  1. Change in Dysphonia Severity Index [ Time Frame: 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) ]
    The DSI is a multiparametric approach designed to establish an objective and quantitative correlate of the perceived vocal quality [19]. It is based on a weighted combination of 4 voice parameters: maximum phonation time (MPT, s), highest frequency (F-high, Hz), lowest intensity (I-low, dB) and jitter (%). The DSI is constructed as 0.13 MPT + 0.0053 F-high - 0.26 I-low - 1.18 jitter +12.4. The index ranges from -5 to +5 for severely dysphonic to normal voices but values higher than +5 are possible in subjects with excellent vocal capacities.

  2. Change in Acoustic Voice Quality Index [ Time Frame: 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) ]
    The AVQI is a robust and valid method to quantify the severity of overall dysphonia based on both continuous and sustained vowel recordings [20]. This multiparameter index consists of a weighted combination of 6 voice parameters: smoothed cepstral peak prominence (CPPS), harmonics-to-noise ratio (HNR), shimmer local (SL), shimmer local dB (SLdB), general slope of the spectrum (slope) and tilt of the regression line through the spectrum (tilt). The formula is constructed as 9.072 - 0.245 × CPPs - 0.161 × HNR - 0.470 × SL + 6.158 × SLdB - 0.071 × Slope - 0.170 × Tilt and ranges from 0 to 10. The higher the score of the AVQI, the worse is the overall vocal quality.

  3. Change in Voice Range Profile [ Time Frame: 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) ]
    The frequency and intensity range of the voices will be measured with the Voice Range Profile software of the Computerized Speech lab of Kay following the procedure of Heylen et al.



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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Study 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).
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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).

Exclusion Criteria:

  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04708600


Contacts
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Contact: Clara Leyns, MSc +32 9 332 01 43 ext +32495724884 clara.leyns@ugent.be
Contact: Patrick Van Gelder +32 9 332 04 59 ext +32472616488 Patrick.vangelder@ugent.be

Locations
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Belgium
Evelien D'haeseleer Recruiting
Gent, Belgium, 9000
Contact: Evelien D'haeseleer, PhD    +32472616488    evelien.dhaeseleer@ugent.be   
Contact: Patrick         
Sponsors and Collaborators
University Ghent
Investigators
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Principal Investigator: Evelien D'haeseleer, PhD University Ghent
Publications:
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Responsible Party: University Ghent
ClinicalTrials.gov Identifier: NCT04708600    
Other Study ID Numbers: B670201941335
First Posted: January 14, 2021    Key Record Dates
Last Update Posted: January 14, 2021
Last Verified: September 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Voice Disorders
Communication Disorders
Gender Dysphoria
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Neurodevelopmental Disorders
Mental Disorders
Laryngeal Diseases
Respiratory Tract Diseases
Otorhinolaryngologic Diseases
Sexual Dysfunctions, Psychological