Speech Disorders Clinical Trial
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.
Status | Recruiting |
Enrollment | 12 |
Est. completion date | June 1, 2025 |
Est. primary completion date | December 1, 2024 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United States | University of California San Diego | La Jolla | California |
Lead Sponsor | Collaborator |
---|---|
University of California, Davis | University of California, San Diego |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | FACT-H&N (Functional Assessment of Cancer Therapy - Head & Neck) | Patient reported survey. | Through study completion; 3 years (anticipate completion by June 2025) | |
Primary | AVHI (Alaryngeal Voice Handicap Index) | Patient reported survey. | Through study completion; 3 years (anticipate completion by June 2025) | |
Secondary | 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 | Through study completion; 3 years (anticipate completion by June 2025) | |
Secondary | Sustained phonation time | A measurement in seconds of how long a patient can sustain phonation. | Through study completion; 3 years (anticipate completion by June 2025) | |
Secondary | Fundamental frequency | A measurement of frequency of voice during alaryngeal speech/sustained phonation | Through study completion; 3 years (anticipate completion by June 2025) |
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