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

NCT05489965 | Recruiting

• 1 other identifier: 1509981
• Study Type: observational
• Target: 12
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (2)

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

  Patient reported survey.

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

• AVHI (Alaryngeal Voice Handicap Index)

  Patient reported survey.

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

Secondary Outcomes (3)

• GRBAS - Grade, Roughness, Breathiness, Asthenia, and Strain

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

• Sustained phonation time

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

• Fundamental frequency

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

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: this trial is studying the disparities amongst genders (male vs. female)
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

patients with advanced laryngeal cancer who have completed total laryngectomy requiring use of alternative methods to produce voice along with extensive speech rehabilitation.

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University of California, San Diego: collaborator
• University of California, Davis: lead

Study Sites (1)

University of California San Diego

La Jolla, California, 92093, United States

RECRUITING

MeSH Terms

Conditions

Speech Disorders

Condition Hierarchy (Ancestors)

Language Disorders; Communication Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Jasmine Cate

CONTACT

8582463035; jcate@health.ucsd.edu

Debanjali Ghosh

CONTACT

858.246.0357; d1ghosh@health.ucsd.edu

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 28, 2022
• First Posted: August 5, 2022
• Study Start: May 31, 2023
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 1, 2026
• Last Updated: February 11, 2026

Record last verified: 2026-02

Locations

US (1)