CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 55 enrolled
Drug / intervention
High-speed video endoscopy (HSV) +2 moredevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT05561920
NCT05561920N/ACompleted

Dependencies of Acoustic Signal and Image Recordings of Phonatory Movement of the Pharyngoesophageal Mucosa in Laryngectomy Patients Using High-speed Video Endoscopy and a Biomechanical Model

Osijek University Hospital·observational·Posted Sep 30, 2022·Updated Mar 31, 2026

In Brief

An observational study evaluating High-speed video endoscopy (HSV), Acoustic voice analysis, and 1 other intervention for Larynx Cancer and Laryngectomy; Status. Completed, enrolled 55 participants across 1 site.

Detailed Summary

The treatment of advanced laryngeal cancer involves the removal of the entire larynx. After removal of the larynx, the pharyngoesophageal segment (PES) is created by reconstructing the soft tissue of the pharynx and oesophagus, and its vibration creates a substitute voice. High-speed video endoscopy (HSV) is the only method that visualises and measures the vibration of the PES after a laryngectomy. The acoustic characteristics of three forms of rehabilitated voice of laryngectomised individuals (oesophageal voice, tracheoesophageal (TE) voice using a voice prosthesis and electrolarynx) have been satisfactorily described, but the interdependence of acoustic and visual representations of the phonatory movement of the PES is still insufficiently studied. In recent years, biomechanical models have been developed to analyse the vibration of the PES, but consistent results have not yet been obtained that would explain whether the parameters from the analysis of the waveform of the PES can be compared with the parameters obtained from the acoustic analysis of the voice of a laryngectomised patient.Effective rehabilitation focuses on optimising speech and swallowing, which leads to a good integration of the laryngectomised person into society. One step towards achieving this goal is a thorough assessment of their voice and communication experiences, as well as analysing the phonatory movements of the PES using HSV technology.

Study Details

Study Typeobservational
Allocation--
Masking--
Primary Purpose--
CountriesCroatia

Timeline

N/ACompletedFinished
2023202420252026
First PostedSep 30, 2022
Enrollment StartAug 1, 2022
Primary CompletionApr 1, 2025
TodayJul 2, 2026
Enrollment to primary: 2.7 yearsPosted 3.8 years ago

Interventions

High-speed video endoscopy (HSV)device

Describe anatomical and morphological characteristics o phonatory movement of pharyngoesophageal segment (PES) in laryngectomy patients

Acoustic voice analysisdevice

acoustic program (lingWAVES - Voice and speech analyser) - measuring the values of acoustic parameters in voice recordings

Quality of life questionnairebehavioral

Filling out questionnaires