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

Part of paid clinical trials in La Jolla, California.

Sponsor
University of California, Davis
Study ID
NCT05489965
Status
Recruiting
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Conditions

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

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Accepted

Study Details

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.

Key Dates

Start date
May 31, 2023
Status verified
Feb 2026
Primary completion
Jun 1, 2026
Completion
Jun 1, 2026

Study Design

Enrollment
12 participants (estimated)

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) ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of California San DiegoLa JollaCalifornia92093
Kristen Linnemeyer, CCC-SLP, BCS-S
[email protected]
Kayleigh N Hernandez, BS
[email protected]
(858) 246-0357

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