Recruiting

Observational Study

Sponsor:

UCLA

Code:

NCT05489965

Conditions

Speech Disorders

Speech Dysfunction

Laryngectomy; Status

Tracheoesophageal Prosthesis

Total Laryngectomy

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Study Details

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

Study ID

NCT05489965

Start date

May 31, 2023

Status verified date

Jul, 2026

Completion date

Sep 1, 2026

Anticipated

Primary completion date

Sep 1, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

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

Study Design

Enrollment

12 participants

Anticipated

Interventions and Outcome Measures

Primary outcome measure

  • FACT-H&N (Functional Assessment of Cancer Therapy - Head & Neck) [ Time Frame: Through study completion; 3 years (anticipate completion by June 2025) ]
  • AVHI (Alaryngeal Voice Handicap Index) [ Time Frame: Through study completion; 3 years (anticipate completion by June 2025) ]

Central Contacts and Locations

Locations

University of California San Diego

Recruiting

La Jolla, California, United States, 92093

Contacts

Kristen Linnemeyer, CCC-SLP, BCS-S

klinnemeyer@health.ucsd.edu

More Information

Sponsor

University of California, Davis

Last update posted

Jul 6, 2026

Last verified

Jul, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of California, Davis on 2026-07-06.