Speech DisordersNCT05489965
Gender Disparities in Voice Outcomes After Tracheoesophageal Puncture in Total Laryngectomy Patients (UC Davis)
An observational study of Speech Disorders and Speech Dysfunction, run by University of California, Davis at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Speech Disorders, Speech Dysfunction, Laryngectomy; Status
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- 31 May 2023to 1 Sep 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- Male and female subjects who have completed total laryngectomy and are using TEP
Who cannot join
- Subjects who have not completed total laryngectomy and are not using TEP
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of California San Diego
La Jolla, California, 92093
Kristen Linnemeyer, CCC-SLP, BCS-S, klinnemeyer@health.ucsd.edu
Kayleigh N Hernandez, BS, (858) 246-0357, knhernandez@health.ucsd.edu
About this study
Official title: Gender Disparities in Voice Outcomes After Tracheoesophageal Puncture in Total Laryngectomy
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.
Read the 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.
- Conditions
- Speech Disorders, Speech Dysfunction, Laryngectomy; Status, Tracheoesophageal Prosthesis, Total Laryngectomy
- Medical subject headings
- Speech Disorders
What is being measured
The primary outcome is the main question the study is designed to answer.
FACT-H&N (Functional Assessment of Cancer Therapy - Head & Neck)
Patient reported survey.
Measured: Through study completion; 3 years (anticipate completion by June 2025)
AVHI (Alaryngeal Voice Handicap Index)
Patient reported survey.
Measured: Through study completion; 3 years (anticipate completion by June 2025)
Secondary outcomes (3)
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
Measured: 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.
Measured: Through study completion; 3 years (anticipate completion by June 2025)
Fundamental frequency
A measurement of frequency of voice during alaryngeal speech/sustained phonation
Measured: Through study completion; 3 years (anticipate completion by June 2025)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2022
- Study start31 May 2023
- Primary completion1 Sep 2026 (estimated)
- Study completion1 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Speech DisordersStudies of the same condition, open and under way.
- More trials run by University of California, DavisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Other
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of California, Davis
- Sponsor type
- University, hospital or other
- Collaborators
- University of California, San Diego
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05489965
- Sponsor's protocol ID
- 1509981
- Status last verified
- Jul 2026
- First submitted
- 28 Jul 2022
- Last updated
- 6 Jul 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Gender Disparities in Voice Outcomes After Tracheoesophageal Puncture in Total Laryngectomy
- ClinicalTrials.gov ID
- NCT05489965
- Acronym / sponsor ID
- 1509981
- Conditions
- Speech Disorders, Speech Dysfunction, Laryngectomy; Status, Tracheoesophageal Prosthesis, Total Laryngectomy
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- University of California, DavisUniversity, hospital or other
- Collaborators
- University of California, San Diego
- Study start
- 31 May 2023 (actual)
- Primary completion
- 1 Sep 2026 (estimated)
- Study completion
- 1 Sep 2026 (estimated)
- First posted
- 5 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Other
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- Male and female subjects who have completed total laryngectomy and are using TEP
Key exclusion criteria (1 listed)
- Subjects who have not completed total laryngectomy and are not using TEP
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
FACT-H&N (Functional Assessment of Cancer Therapy - Head & Neck)
Time frame: Through study completion; 3 years (anticipate completion by June 2025)
Patient reported survey.
AVHI (Alaryngeal Voice Handicap Index)
Time frame: Through study completion; 3 years (anticipate completion by June 2025)
Patient reported survey.
3 secondary outcomes
GRBAS - Grade, Roughness, Breathiness, Asthenia, and Strain
Time frame: Through study completion; 3 years (anticipate completion by June 2025)
Sustained phonation time
Time frame: Through study completion; 3 years (anticipate completion by June 2025)
Fundamental frequency
Time frame: Through study completion; 3 years (anticipate completion by June 2025)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jul 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Speech Disorders and Speech Dysfunction, run by University of California, Davis at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 6 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jasmine Cate (8582463035, jcate@health.ucsd.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jul 2026.