An observational study in Speech Disorders, Speech Dysfunction and Laryngectomy; Status, sponsored by University of California, Davis. Recruiting at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-07-06.
Sponsored by University of California, Davis · Observational
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.
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.
77 studies on the registry are indexed under Speech Disorders; 20 are open to participants now.
This study's planned enrollment of 12 is below the median of 50 across 23 observational studies indexed under Speech Disorders.
Browse Speech Disorders studies →University of California, Davis is the lead sponsor of 809 studies on the registry; 142 are open to participants now.
Of its 67 completed or terminated interventional studies of FDA-regulated products, 43 (64%) have results posted.
Counted across the registry records on this site, refreshed daily.
patients with advanced laryngeal cancer who have completed total laryngectomy requiring use of alternative methods to produce voice along with extensive speech rehabilitation.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
FACT-H&N (Functional Assessment of Cancer Therapy - Head & Neck)
Patient reported survey.
Time frame: Through study completion; 3 years (anticipate completion by June 2025)
AVHI (Alaryngeal Voice Handicap Index)
Patient reported survey.
Time frame: Through study completion; 3 years (anticipate completion by June 2025)
GRBAS - Grade, Roughness, Breathiness, Asthenia, and Strain
Examiner-based interpretation of roughness/breathiness of patient's voice. Scale of 0-3, 3 indicating severe, 0 indicating normal
Time frame: Through study completion; 3 years (anticipate completion by June 2025)
Sustained phonation time
A measurement in seconds of how long a patient can sustain phonation.
Time frame: Through study completion; 3 years (anticipate completion by June 2025)
Fundamental frequency
A measurement of frequency of voice during alaryngeal speech/sustained phonation
Time frame: Through study completion; 3 years (anticipate completion by June 2025)
Started May 2023 (actual). Primary completion is estimated for Sep 2026, 39 months after the start.
How these figures are worked out, and which studies are left out of them.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
University of California, Davis →