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

Gender Disparities in Voice Outcomes After Tracheoesophageal Puncture in Total Laryngectomy

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05489965
Enrollment
12
Registered
2022-08-05
Start date
2023-05-31
Completion date
2026-09-01
Last updated
2026-07-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Laryngectomy; Status, Speech Disorders, Speech Dysfunction, Total Laryngectomy, Tracheoesophageal Prosthesis

Brief summary

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.

Detailed description

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.

Interventions

None listed

Sponsors

University of California, Davis
Lead SponsorOTHER
University of California, San Diego
CollaboratorOTHER

Study design

Observational model
OTHER
Time perspective
OTHER

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
FACT-H&N (Functional Assessment of Cancer Therapy - Head & Neck)Through study completion; 3 years (anticipate completion by June 2025)Patient reported survey.
AVHI (Alaryngeal Voice Handicap Index)Through study completion; 3 years (anticipate completion by June 2025)Patient reported survey.

Secondary

MeasureTime frameDescription
GRBAS - Grade, Roughness, Breathiness, Asthenia, and StrainThrough 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
Sustained phonation timeThrough study completion; 3 years (anticipate completion by June 2025)A measurement in seconds of how long a patient can sustain phonation.
Fundamental frequencyThrough study completion; 3 years (anticipate completion by June 2025)A measurement of frequency of voice during alaryngeal speech/sustained phonation

Countries

United States

Contacts

CONTACTJasmine Cate
jcate@health.ucsd.edu8582463035
CONTACTDebanjali Ghosh
d1ghosh@health.ucsd.edu858.246.0357

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jul 7, 2026