Actively Recruiting
Gender Disparities in Voice Outcomes After Tracheoesophageal Puncture in Total Laryngectomy
Led by University of California, Davis · Updated on 2026-02-11
12
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
U
University of California, Davis
Lead Sponsor
U
University of California, San Diego
Collaborating Sponsor
AI-Summary
What this Trial Is About
This research aims to assess differences in speech outcomes between male and female patients who use a tracheoesophageal prosthesis (TEP) after total laryngectomy, a surgery removing the voice box due to advanced laryngeal cancer. It focuses on both subjective and objective measures of voice, speech, and quality of life, as prior studies indicate female patients may experience poorer outcomes compared to males. The study is conducted across multiple sites to better understand these gender disparities in voice rehabilitation after laryngectomy. Participants have undergone total laryngectomy and currently use TEP to produce speech. The study evaluates voice outcomes using multiple scales, including acoustic analysis, perceptual evaluation, and patient-reported measures. The primary outcomes include quality of life and voice handicap indexes, while secondary measures assess voice quality aspects like breathiness, sustained phonation, and fundamental frequency. Data collection is planned over approximately three years. During the study, participants will complete assessments such as the Functional Assessment of Cancer Therapy - Head & Neck (FACT-H&N) and the Alaryngeal Voice Handicap Index (AVHI). Voice quality will also be evaluated using GRBAS scales and phonation measurements. These evaluations will continue through the study period to monitor voice and speech function changes. The study is observational and may include healthy volunteers who meet the criteria, with participation lasting up to three years.
CONDITIONS
Brief Title
Gender Disparities in Voice Outcomes After Tracheoesophageal Puncture in Total Laryngectomy Patients (UC Davis)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male and female subjects who have completed total laryngectomy
- Subjects currently using a tracheoesophageal prosthesis (TEP)
You will not qualify if you...
- Subjects who have not completed total laryngectomy
- Subjects who are not using a tracheoesophageal prosthesis (TEP)
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 3 years
Participants who have completed total laryngectomy and use a tracheoesophageal prosthesis are observed to assess voice outcomes and quality of life using various scales and acoustic measurements.
Visits scheduled through study completion for assessments
Trial Site Locations
Total: 1 location
1
University of California San Diego
La Jolla, California, United States, 92093
Actively Recruiting
Research Team
J
Jasmine Cate
D
Debanjali Ghosh
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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