NCT05561920

Phonatory Movement of the Pharyngoesophageal Mucosa in Laryngectomy Patients

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 55 (actual)
• Sponsor: Osijek University Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 90 Years
• Healthy volunteers: Not accepted

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.

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 (%).

Conditions

• Larynx Cancer
• Laryngectomy; Status

Interventions

Type	Name	Description
DEVICE	High-speed video endoscopy (HSV)	Describe anatomical and morphological characteristics o phonatory movement of pharyngoesophageal segment (PES) in laryngectomy patients
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

Timeline

• Start date: 2022-08-01
• Primary completion: 2025-04-01
• Completion: 2025-04-01
• First posted: 2022-09-30
• Last updated: 2026-03-31
• Results posted: 2026-03-11

Locations

1 site across 1 country: Croatia