Skip to main content
OpenTrials
Completed

NCT Number: NCT05561920

Phonatory Movement of the Pharyngoesophageal Mucosa in Laryngectomy Patients

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Larynx Cancer Behavior Communication Head and Neck Neoplasms Laryngeal Diseases Laryngeal Neoplasms Laryngectomy; Status Neoplasms Neoplasms by Site Otorhinolaryngologic Diseases Otorhinolaryngologic Neoplasms Respiratory Tract Diseases Respiratory Tract Neoplasms Speech Verbal Behavior

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Observational

Primary location

University Hospital Osijek

Osijek, 31000, Croatia

About this study

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 (%).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

High-speed video endoscopy (HSV)

Device

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

Acoustic voice analysis

Device

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

Quality of Life Questionnaire

Behavioral

Filling out questionnaires

Primary outcomes

  1. 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.

  2. 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

  3. 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

  4. 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 (%)

  5. 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.

  6. 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.

  7. 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.

  8. 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).

  9. 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).

  10. 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).

Sponsors and collaborators

Lead sponsor

Osijek University Hospital

Other

Collaborators

  • Josip Juraj Strossmayer University of Osijek

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2025
Study completion
2025
First posted
Sep 30, 2022
Registry last updated
Mar 31, 2026

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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.