University of California San Diego
La Jolla, California, 92093, United States
Location status: Recruiting
Location contact
Kayleigh N Hernandez, BS
CONTACT
Kristen Linnemeyer, CCC-SLP, BCS-S
CONTACT
NCT Number: NCT05489965
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.
Interested in participating?
Request Info18 year and older
All sexes
Observational
La Jolla, California, 92093, United States
Location status: Recruiting
Kayleigh N Hernandez, BS
CONTACT
Kristen Linnemeyer, CCC-SLP, BCS-S
CONTACT
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Time frame: Through study completion; 3 years (anticipate completion by June 2025)
Patient reported survey.
Time frame: Through study completion; 3 years (anticipate completion by June 2025)
Patient reported survey.
Time frame: Through study completion; 3 years (anticipate completion by June 2025)
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)
A measurement in seconds of how long a patient can sustain phonation.
Time frame: Through study completion; 3 years (anticipate completion by June 2025)
A measurement of frequency of voice during alaryngeal speech/sustained phonation
Contact information is provided by the study sponsor or research team.
Debanjali Ghosh
CONTACT
Jasmine Cate
CONTACT
University of California, Davis
Other
Gender Disparities in Voice Outcomes After Tracheoesophageal Puncture in Total Laryngectomy
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT04690166
Behavior, Communication
Istanbul, Turkey (Türkiye)
View Trial DetailsNCT04117360
Communication Disorders, Congenital Abnormalities
Chapel Hill, North Carolina, United States
View Trial DetailsNCT05741853
Alzheimer Disease, Aphasia
Austin, Texas, United States
View Trial DetailsNCT05695131
Behavior, Communication
Edmonton, Alberta, Canada
View Trial Details