Skip to main content
OpenTrials
Recruiting

NCT Number: NCT05489965

Gender Disparities in Voice Outcomes After Tracheoesophageal Puncture in Total Laryngectomy Patients (UC Davis)

To perform a multi-site prospective study assessing, both subjectively and objectively, the gender disparities in speech outcomes of patients using TEP after total laryngectomy.

The investigators hypothesize that speech outcomes, both subjective and objective measures, will be significantly poorer for female patients compared to male patients. The outcome of the study is to prospectively assess both subjective and objective gender disparities in voice and speech outcomes of patients using TEP after total laryngectomy across a multiple institutions. The investigators hypothesize that both subjective and objective measurements of voice, speech and quality of life will be poorer for female patients in comparison to male patients.

Recruiting

Interested in participating?

Request Info

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University of California San Diego

La Jolla, California, 92093, United States

Location status: Recruiting

Location contact

Kayleigh N Hernandez, BS

CONTACT

[email protected]

(858) 246-0357

Kristen Linnemeyer, CCC-SLP, BCS-S

CONTACT

[email protected]

About this study

Total laryngectomy (TL) is typically performed in patients with advanced laryngeal cancer as a means of removing the entire larynx and surrounding structures that have been affected by the malignancy. Following total laryngectomy, patients lose ability to produce voice. Thus, they require the use of alternative methods of to produce voice along with extensive speech rehabilitation. Currently, there are three main speech alternative options, esophageal speech, tracheoesophageal speech, and electrolarynx speech. The focus of this study will be on patients rehabilitating their speech using tracheosophgeal speech through a tracheoesophageal prosthesis (TEP). It has been shown that generally for TL patients, better voice quality and satisfaction with voice is associated with improved quality of life. Currently, speech rehabilitation outcomes are measured with a multidimensional approach, using various scales ranging from acoustic analysis, perceptual evaluation, and patient-reported outcomes. The majority of studies analyzing outcomes in total laryngectomy patients, however, is predominated by assessment of the male laryngectomee population. Historically, this has been due to the greater incidence of laryngeal cancers in males than females. Due to this, there has been minimal research investigating potential gender differences in the laryngectomy population. Of the limited data available regarding the female laryngectomee population, it has been shown that gender frequency differences seen in normal subjects are lost following total laryngectomy and the resulting tracheoesophageal voice is more similar to the normal male voice, thus females face a greater voice handicap compared to their male counterparts (Kazi, 2006; Deore, 2011). While some studies have assessed the resulting quality of life differences between the genders in the laryngectomy population (Lee, 2010), few have investigated voice outcomes using both subjective and objective scales as used in this study. The outcomes of this study will be key to understanding what metrics are potentially contributing to the voice and lifestyle dissatisfaction that prior studies have demonstrated in the female laryngectomee population. This quantifiable data will provide a way of modifying future voice rehabilitation in the female population to enable better satisfaction and minimize gender differences in voice outcomes.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Male and female subjects who have completed total laryngectomy and are using TEP

Exclusion criteria

  • Subjects who have not completed total laryngectomy and are not using TEP

Treatment and study plan

Primary outcomes

  1. FACT-H&N (Functional Assessment of Cancer Therapy - Head & Neck)

    Time frame: Through study completion; 3 years (anticipate completion by June 2025)

    Patient reported survey.

  2. AVHI (Alaryngeal Voice Handicap Index)

    Time frame: Through study completion; 3 years (anticipate completion by June 2025)

    Patient reported survey.

Secondary outcomes

  1. GRBAS - Grade, Roughness, Breathiness, Asthenia, and Strain

    Time frame: Through study completion; 3 years (anticipate completion by June 2025)

    Examiner-based interpretation of roughness/breathiness of patient's voice. Scale of 0-3, 3 indicating severe, 0 indicating normal

  2. Sustained phonation time

    Time frame: Through study completion; 3 years (anticipate completion by June 2025)

    A measurement in seconds of how long a patient can sustain phonation.

  3. Fundamental frequency

    Time frame: Through study completion; 3 years (anticipate completion by June 2025)

    A measurement of frequency of voice during alaryngeal speech/sustained phonation

Study contacts

Contact information is provided by the study sponsor or research team.

Debanjali Ghosh

CONTACT

[email protected]

858.246.0357

Jasmine Cate

CONTACT

[email protected]

8582463035

Sponsors and collaborators

Lead sponsor

University of California, Davis

Other

Collaborators

  • University of California, San Diego

Registry information

Official study title

Gender Disparities in Voice Outcomes After Tracheoesophageal Puncture in Total Laryngectomy

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Aug 5, 2022
Registry last updated
Jul 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.