NCT05561920 · REGISTRY CONDITION SEARCH

Phonatory Movement of the Pharyngoesophageal Mucosa in Laryngectomy Patients

Found through the registry condition index, not selected as a treatment recommendation. This discovery collection was restricted to studies with posted results.

Phase: Not reported
Status at capture: COMPLETED
Registry last update: 2026-03-31

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.

Open the original ClinicalTrials.gov record → · Download preserved record

What did the study report?

Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.

flow

Participant flow

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baseline

Baseline characteristics

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outcome · POSTED

High Speed Video Endoscopy Recordings

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outcome · POSTED

The Measures of Central Tendency and Dispersion in Acoustic Signal - Fundamental Frequency

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outcome · POSTED

The Measures of Central Tendency and Dispersion in Acoustic Signal - Intensity of Substitute Voice

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outcome · POSTED

The Measures of Central Tendency and Dispersion in Acoustic Signal - Relative Jitter and Shimmer

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outcome · POSTED

The Measures of Central Tendency and Dispersion of Maximum Phonation Time (MPT)

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outcome · POSTED

Croatian Version of the SECEL (SECEL:HR) Questionnaire.

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outcome · POSTED

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

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outcome · POSTED

The Results of Pharyngoesophageal Segment (PES) Vibration Analysed With the Biomechanical Model Obtained by High - Speed Video Endoscopy - Central Tendency and Dispersion - Mean Shimmer

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outcome · POSTED

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

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outcome · POSTED

The Results of Pharyngoesophageal Segment (PES) Vibration Analysed With the Biomechanical Model Obtained by High - Speed Video Endoscopy - Central Tendency and Dispersion - Fundamental Frequency

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adverse events

Adverse events

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more info

Limitations, agreements, and source contact

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Who could take part

eligibility Criteria: 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
healthy Volunteers: false
maximum Age: 90 Years
minimum Age: 18 Years
sampling Method: PROBABILITY_SAMPLE
sex: ALL
std Ages: ADULT
OLDER_ADULT
study Population: adult male laryngectomised patients who completed oncological treatment and underwent voice rehabilitation

Treatment arms and interventions

arm Groups

description
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
intervention Names
Device: High-speed video endoscopy (HSV)
Device: Acoustic voice analysis
Behavioral: Quality of life questionnaire
label
Adult laryngectomised patients

interventions

arm Group Labels
Adult laryngectomised patients
description
Describe anatomical and morphological characteristics o phonatory movement of pharyngoesophageal segment (PES) in laryngectomy patients
name
High-speed video endoscopy (HSV)
type
DEVICE
arm Group Labels
Adult laryngectomised patients
description
acoustic program (lingWAVES - Voice and speech analyser) - measuring the values of acoustic parameters in voice recordings
name
Acoustic voice analysis
type
DEVICE
arm Group Labels
Adult laryngectomised patients
description
Filling out questionnaires
name
Quality of life questionnaire
type
BEHAVIORAL

Study design

observational Model: COHORT
time Perspective: PROSPECTIVE

Enrollment

count: 55
type: ACTUAL

Registered outcome plans (not posted results)

primary Outcomes

description
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.
measure
High Speed Video Endoscopy Recordings
time Frame
15 minutes for each participants
description
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
measure
The Measures of Central Tendency and Dispersion in Acoustic Signal - Fundamental Frequency
time Frame
15 minutes
description
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
measure
The Measures of Central Tendency and Dispersion in Acoustic Signal - Intensity of Substitute Voice
time Frame
15 minutes
description
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 (%)
measure
The Measures of Central Tendency and Dispersion in Acoustic Signal - Relative Jitter and Shimmer
time Frame
15 minutes
description
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.
measure
The Measures of Central Tendency and Dispersion of Maximum Phonation Time (MPT)
time Frame
2 minutes
description
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.
measure
Croatian Version of the SECEL (SECEL:HR) Questionnaire.
time Frame
15 minutes
description
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.
measure
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
description
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).
measure
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
description
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).
measure
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
description
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).
measure
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

Full study description

brief 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 (%).

Source references

references

citation
Zenga J, Goldsmith T, Bunting G, Deschler DG. State of the art: Rehabilitation of speech and swallowing after total laryngectomy. Oral Oncol. 2018 Nov;86:38-47. doi: 10.1016/j.oraloncology.2018.08.023. Epub 2018 Sep 12.
pmid
30409318
type
BACKGROUND
citation
van As CJ, Tigges M, Wittenberg T, Op de Coul BM, Eysholdt U, Hilgers FJ. High-speed digital imaging of neoglottic vibration after total laryngectomy. Arch Otolaryngol Head Neck Surg. 1999 Aug;125(8):891-7. doi: 10.1001/archotol.125.8.891.
pmid
10448737
type
BACKGROUND
citation
Schwarz R, Huttner B, Dollinger M, Luegmair G, Eysholdt U, Schuster M, Lohscheller J, Gurlek E. Substitute voice production: quantification of PE segment vibrations using a biomechanical model. IEEE Trans Biomed Eng. 2011 Oct;58(10):2767-76. doi: 10.1109/TBME.2011.2151860. Epub 2011 May 10.
pmid
21558056
type
BACKGROUND
citation
Huttner B, Luegmair G, Patel RR, Ziethe A, Eysholdt U, Bohr C, Sebova I, Semmler M, Dollinger M. Development of a time-dependent numerical model for the assessment of non-stationary pharyngoesophageal tissue vibrations after total laryngectomy. Biomech Model Mechanobiol. 2015 Jan;14(1):169-84. doi: 10.1007/s10237-014-0597-1. Epub 2014 May 27.
pmid
24861998
type
BACKGROUND
citation
Schlegel P, Stingl M, Kunduk M, Kniesburges S, Bohr C, Dollinger M. Dependencies and Ill-designed Parameters Within High-speed Videoendoscopy and Acoustic Signal Analysis. J Voice. 2019 Sep;33(5):811.e1-811.e12. doi: 10.1016/j.jvoice.2018.04.011. Epub 2018 May 31.
pmid
29861291
type
BACKGROUND
citation
Schindler A, Mozzanica F, Brignoli F, Maruzzi P, Evitts P, Ottaviani F. Reliability and validity of the Italian self-evaluation of communication experiences after laryngeal cancer questionnaire. Head Neck. 2013 Nov;35(11):1606-15. doi: 10.1002/hed.23198. Epub 2012 Nov 20.
pmid
23169480
type
BACKGROUND
citation
Debruyne F, Delaere P, Wouters J, Uwents P. Acoustic analysis of tracheo-oesophageal versus oesophageal speech. J Laryngol Otol. 1994 Apr;108(4):325-8. doi: 10.1017/s0022215100126660.
pmid
8182320
type
BACKGROUND
citation
Dooks P, McQuestion M, Goldstein D, Molassiotis A. Experiences of patients with laryngectomies as they reintegrate into their community. Support Care Cancer. 2012 Mar;20(3):489-98. doi: 10.1007/s00520-011-1101-4. Epub 2011 Feb 6.
pmid
21298450
type
BACKGROUND

Source notices and limitations

Discovery and provenance

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Preserved source evidence · Not medical advice