Actively Recruiting

Age: 18Years +
All Genders
Healthy Volunteers
ID05489965

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

Age: 18Years +
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Male and female subjects who have completed total laryngectomy
  • Subjects currently using a tracheoesophageal prosthesis (TEP)
Not Eligible

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

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Long-term Monitoring

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

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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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