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Mobile App Voice Therapy for Transitioning Voice
N/A
Waitlist Available
Led By Anais Rameau, MD, MPhil
Research Sponsored by Weill Medical College of Cornell University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, week 4, week 11
Awards & highlights
No Placebo-Only Group
Summary
This trial will assess if an app can help transgender and gender diverse people improve their voice quality as much as traditional speech therapy.
Who is the study for?
This trial is for transgender and gender diverse individuals over 18 who own an iOS device and can read/write in English. It's not suitable for cisgender people or those with voice-related issues like hoarseness or pain.
What is being tested?
The study tests a mobile app called Attuned, designed to help with voice modification, against traditional in-person therapy. The effectiveness will be judged by participants' satisfaction with their voices and objective measures of voice quality.
What are the potential side effects?
Since this trial involves non-medical interventions (voice therapy via an app), side effects are minimal but may include temporary vocal strain or fatigue from practicing new speaking techniques.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline, week 4, week 11
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, week 4, week 11
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Change in Formants
Change in Fundamental Frequency
Change in Transgender Self Evaluation Questionnaire (TSEQ) Scores
+1 moreSecondary study objectives
Usability of Mobile Application as measured by the Mobile Application Rating Scale (MARS)
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Transgender and gender diverse (TGGD) individuals using the pilot appExperimental Treatment1 Intervention
The investigators will develop Attuned, an open access voice and communication modification training (VCMT) app based on standard of care. Participants will undergo VCMT via the mobile application, Attuned. Participants will include healthy transgender and gender diverse (TGGD) individuals seeking voice modification to better reflect their identity.
Group II: Transgender and gender diverse (TGGD) individuals receiving standard voice modificationActive Control1 Intervention
VCMT via speech pathology will be compared to the efficacy of an app-based VCMT program. Participants will undergo VCMT in-person. Participants will include healthy transgender and gender diverse (TGGD) individuals seeking voice modification to better reflect their identity.
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Who is running the clinical trial?
Weill Medical College of Cornell UniversityLead Sponsor
1,092 Previous Clinical Trials
1,154,736 Total Patients Enrolled
Ithaca CollegeOTHER
7 Previous Clinical Trials
1,015 Total Patients Enrolled
Anais Rameau, MD, MPhilPrincipal InvestigatorWeill Medical College of Cornell University
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I identify as the gender I was assigned at birth.I have been experiencing hoarseness.I identify as a transgender individual.I experience pain when I use my voice.I am 18 years old or older.
Research Study Groups:
This trial has the following groups:- Group 1: Transgender and gender diverse (TGGD) individuals using the pilot app
- Group 2: Transgender and gender diverse (TGGD) individuals receiving standard voice modification
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.