Phonatory Movement of the Pharyngoesophageal Mucosa in Laryngectomy Patients

March 11, 2026 updated by: Osijek University Hospital

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

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The first aim of this study is to describe phonatory movement of pharyngoesophageal segment (PES) in laryngectomy patients with HSV and then with biomechanical model. Analyse these recordings and examine the impact of loss of voice in terms of psychological and socioeconomic problems in laryngectomy patients using Croatian version of the Self-Evaluation of Communication Experiences after Laryngectomy (SECEL:HR) questionnaire.

This is a non-interventional, prospective study of laryngectomised participants ( 55 participants) who completed oncological treatment and underwent voice rehabilitation. A consent form will be signed.

Exclusion criteria included individuals with acute upper or lower respiratory tract infections, a second primary cancer in the upper aerodigestive tract or lungs, and individuals with neurological or psychiatric disorders.

Each participant underwent a complete otolaryngological examination. The video recordings of the PES were made with a 90° rigid HSV system Wolf 5562 Hres ENDOCAM (frame rate: 4000 fps, resolution: 256×256 pixels). All subjects phonated the vowel "a" at a comfortable pitch and volume. Visual assessment of the HSV recordings was performed including the assessments of the overall quality of the recordings and the assessments of anatomical and morphological features of the PES: amount of saliva, visibility and shape of the PES, location of visible vibration, presence of a mucosal wave and regularity of the vibration.

Each respondent completed the Croatian version of the Self-Evaluation of Communication Experiences after Laryngectomy (SECEL:HR) questionnaire, specifically designed to address the communication needs of patients who have undergone a laryngectomy. The first part of SECEL:HR examines patient-relevant data, while the second part consists of 35 items designed as questions or statements to explore communication experiences. Patients rate the frequency of these communication difficulties on a Likert scale (0-never, 1-sometimes, 2-often, 3-always). The 35 items are divided into 3 subscales: General (0-15 points), Environment (0-42 points) and Attitude (0-45 points). Item number 35 is a separate question: "Do you talk the same amount now as you did before your laryngectomy?" and is scored with the rating categories "yes"," "more" and "less". The total numerical score ranges from 0 to 102, with a higher score indicating greater difficulty and poorer postoperative adaptation of speech communication.

The acoustic analysis of the tracheoesophageal (TE) voice with a voice prosthesis was performed in a quiet room (ambient noise < 50 dB) with a microphone placed 30 cm from the mouth to create optimal conditions for recording and analysis. Three consecutive measurements were taken. The voice recordings were analysed using the acoustic programme lingWAVES (Voice and speech analyser version 2.x software). The following parameters were recorded from the central part of the best recording: fundamental frequency (F0) (Hz), jitter (%), shimmer (%) and the intensity of substitute voice (dB). The value of the maximal phonation time (MPT; ms) was taken as the value of the longest possible relaxed phonation of the vowel "a".

A multi-mass coupled biomechanical model was developed as a multidimensional time sequence of PES mucosal contractions in the form of the opening width observed for each frame of the video time sequence at different angles.

The biomechanical model of the PES analyses non-stationary pharyngoesophageal vibrations and draws conclusions about the temporal characteristics of tissue stiffness, oscillatory mass, pressure and geometric distributions within the PES. The biomechanical model identifies mathematical dependencies and analyses extracted time signals of the PES opening and contours (i.e. the opening and closing of the vibrating mucosa of the PES). Using the PES waveform, we were able to calculate cycle duration, open and closed phase duration (%), fundamental frequency (Hz), mean shimmer (dB), relative shimmer (%), mean jitter (s) and relative jitter (%).

Study Type

Observational

Enrollment (Actual)

55

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Croatia
      • Osijek, Croatia, 31000
        • University Hospital Osijek

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

adult male laryngectomised patients who completed oncological treatment and underwent voice rehabilitation

Description

Inclusion Criteria:

  • laryngectomised patients who completed minimal their 6-month period without disease after surgery and post-operative treatments such as radiotherapy or chemotherapy
  • patients with preserved reading skills
  • regular presence at follow-up visits

Exclusion Criteria:

  • age less than 18 years
  • acute respiratory infection of the upper or lower respiratory tract
  • other primary cancer in the upper aerodigestive tract or lung
  • presence of neurologic or pulmonary diseases

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Adult laryngectomised patients
Patients who have undergone total laryngectomy and completed minimal their 6-month period without disease after surgery and post-operative treatments such as radiotherapy or chemotherapy
Device: Acoustic voice analysis
acoustic program (lingWAVES - Voice and speech analyser) - measuring the values of acoustic parameters in voice recordings
Behavioral: Quality of life questionnaire
Filling out questionnaires
Device: High-speed video endoscopy (HSV)
Describe anatomical and morphological characteristics o phonatory movement of pharyngoesophageal segment (PES) in laryngectomy patients

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
High Speed Video Endoscopy Recordings
Time Frame: 15 minutes for each participants
Visual recording of the mucosa of the pharyngoesophageal segment (PES) performed with High speed video endoscopy (HSV) during the phonation of the vowel "a".The video recordings of the PES were made with a 90° rigid HSV system Wolf 5562 Hres ENDOCAM (frame rate: 4000 fps, resolution: 256×256 pixels). All subjects phonated the vowel "a" at a comfortable pitch and volume. Visual assessment of the HSV recordings was performed using the protocol including the assessments of the overall quality of the recordings (assessability, brightness and focus) and the assessments of anatomical and morphological features of the PES: amount of saliva, visibility and shape of the PES, location of visible vibration, presence of a mucosal wave and regularity of the vibration.
15 minutes for each participants
The Measures of Central Tendency and Dispersion in Acoustic Signal - Fundamental Frequency
Time Frame: 15 minutes
The acoustic analysis of the tracheoesophageal (TE) voice with a voice prosthesis was performed in a quiet room (ambient noise < 50 dB) with a microphone placed 30 cm from the mouth to create optimal conditions for recording and analysis. Three consecutive measurements were taken. The voice recordings were analysed using the acoustic programme lingWAVES (Voice and speech analyser version 2.x software). The fundamental frequency (Hz) parameter was recorded from the central part of the best recording
15 minutes
The Measures of Central Tendency and Dispersion in Acoustic Signal - Intensity of Substitute Voice
Time Frame: 15 minutes
The acoustic analysis of the tracheoesophageal (TE) voice with a voice prosthesis was performed in a quiet room (ambient noise < 50 dB) with a microphone placed 30 cm from the mouth to create optimal conditions for recording and analysis. Three consecutive measurements were taken. The voice recordings were analysed using the acoustic programme lingWAVES (Voice and speech analyser version 2.x software). Intensity of substitute voice was recorded from the central part of the best recording
15 minutes
The Measures of Central Tendency and Dispersion in Acoustic Signal - Relative Jitter and Shimmer
Time Frame: 15 minutes
The acoustic analysis of the tracheoesophageal (TE) voice with a voice prosthesis was performed in a quiet room (ambient noise < 50 dB) with a microphone placed 30 cm from the mouth to create optimal conditions for recording and analysis. Three consecutive measurements were taken. The voice recordings were analysed using the acoustic programme lingWAVES (Voice and speech analyser version 2.x software). The following parameters were recorded from the central part of the best recording: jitter (%), shimmer (%)
15 minutes
The Measures of Central Tendency and Dispersion of Maximum Phonation Time (MPT)
Time Frame: 2 minutes

Measurement of the longest possible relaxed phonation of the voice "a" by a speech therapist

The maximum phonation time (measured in seconds) for which a person can sustain a vowel sound when produced on 1 deep breath at a comfortable pitch and loudness and is a common clinical measure of glottal efficiency.
2 minutes
Croatian Version of the SECEL (SECEL:HR) Questionnaire.
Time Frame: 15 minutes
Completing the Croatian version of the Self-Evaluation of Communication Experiences after Laryngectomy (SECEL) questionnaire. Questionnaire consists of two parts. The first part examines the relevant general data on the person filling out the questionnaire, while the second part consists of 35 items questionably or statement-designed to examine communication experiences. Patients estimates the incidence of these communication difficulties on the Likert scale (0-never, 1-sometimes, 2-often, 3-always). The 35 items are divided into 3 subscales: General (0-15 points), Environment (0-42 points) and Attitude (0-45 points). Item number 35 is a separate question: "Do you talk the same amount now as you did before your laryngectomy?" and is scored with the rating categories "yes"," "more" and "less". The total numerical score ranges from 0 to 102, with a higher score indicating greater difficulty and poorer postoperative adaptation of speech communication.
15 minutes
The Results of Pharyngoesophageal Segment (PES) Vibration Analysed With the Biomechanical Model Obtained by High - Speed Video Endoscopy - Central Tendency and Dispersion - Mean Shimmer
Time Frame: 3 months
The development of the biomechanical model of the PES in order to quantify non-stationary pharyngoesophageal vibrations and drawing conclusions on the temporal characteristics of tissue stiffness, oscillating mass, pressure, and geometric distributions within the PES. The biomechanical model identify mathematical dependencies and analyse extracted time signals of the PES opening and contours (i.e. the opening and closing of the vibrating mucosa of the PES). The PES waveform allowed us to calculate mean shimmer (dB).
3 months
The Results of Pharyngoesophageal Segment (PES) Vibration Analysed With the Biomechanical Model Obtained by High - Speed Video Endoscopy - Central Tendency and Dispersion of Mean Jitter
Time Frame: 3 months
The development of the biomechanical model of the PES in order to quantify non-stationary pharyngoesophageal vibrations and drawing conclusions on the temporal characteristics of tissue stiffness, oscillating mass, pressure, and geometric distributions within the PES. The biomechanical model identify mathematical dependencies and analyse extracted time signals of the PES opening and contours (i.e. the opening and closing of the vibrating mucosa of the PES). The PES waveform allowed us to calculate mean jitter (s).
3 months
The Results of Pharyngoesophageal Segment (PES) Vibration Analysed With the Biomechanical Model Obtained by High - Speed Video Endoscopy - Central Tendency and Dispersion - Fundamental Frequency
Time Frame: 3 months
The development of the biomechanical model of the PES in order to quantify non-stationary pharyngoesophageal vibrations and drawing conclusions on the temporal characteristics of tissue stiffness, oscillating mass, pressure, and geometric distributions within the PES. The biomechanical model identify mathematical dependencies and analyse extracted time signals of the PES opening and contours (i.e. the opening and closing of the vibrating mucosa of the PES). The PES waveform allowed us to calculate the fundamental frequency (Hz).
3 months
The Results of Pharyngoesophageal Segment (PES) Vibration Analysed With the Biomechanical Model Obtained by High - Speed Video Endoscopy - Central Tendency and Dispersion - Open and Closed Phase Duration (%), Relative Shimmer and Relative Jitter
Time Frame: 3 months
The development of the biomechanical model of the PES aims to quantify non-stationary pharyngoesophageal vibrations and draw conclusions about the temporal characteristics of tissue stiffness, oscillating mass, pressure, and geometric distributions within the PES. The biomechanical model identifies mathematical dependencies and analyses extracted time signals of the PES opening and contours (i.e. the opening and closing of the vibrating mucosa of the PES). The PES waveform allows calculation of relative shimmer (%), relative jitter (%), and the duration of the open and closed phases (%), or the percentage of open or closed time of the PES, which is calculated from the PES waveform using the formulas listed in reference 5.
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Osijek University Hospital

Collaborators

Josip Juraj Strossmayer University of Osijek

Investigators

  • Study Chair: Ana Đanić Hadžibegović, Assoc. Prof, Clinical Hospital Centre Zagreb
  • Study Chair: Andrijana Včeva, Full Prof, University Hospital Osijek

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 1, 2022

Primary Completion (Actual)

April 1, 2025

Study Completion (Actual)

April 1, 2025

Study Registration Dates

First Submitted

September 15, 2022

First Submitted That Met QC Criteria

September 27, 2022

First Posted (Actual)

September 30, 2022

Study Record Updates

Last Update Posted (Actual)

March 31, 2026

Last Update Submitted That Met QC Criteria

March 11, 2026

Last Verified

June 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • OsijekUH-HS camera

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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