Respiratory Tract (Lung and Bronchial) Diseases

Ear, Nose, and Throat Diseases

All Conditions

Neoplasms

Laryngeal Diseases

Laryngeal Neoplasms

Otorhinolaryngologic Neoplasms

Head and Neck Neoplasms

Respiratory Tract Diseases

Respiratory Tract Neoplasms

Otorhinolaryngologic Diseases

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

Describe anatomical and morphological characteristics o phonatory movement of PEM in laryngectomy patients

High - speed video endoscopy (HSV)

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

Acoustic voice analysis

Quality of life questionnaire

Željka Laksar Klarić, M.D.

Ana Đanić Hadžibegović, Assoc. Prof

Andrijana Včeva, Full Prof

Therapy of advanced cancer of the larynx includes excision of the entire larynx. After the removal of the larynx, the pharyngoesophageal segment (PES) is created by reconstruction of the soft tissue of the pharynx and oesophagus, and its vibration creates a replacement voice. High-speed video endoscopy (HSV) is the only method that visualizes and measures vibration of pharyngoesophageal mucosa (PEM) after laryngectomy. Acoustic characteristics of three forms of the rehabilitated voice of laryngectomized persons (oesophageal voice, tracheoesophageal voice using a speech 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 investigated. In recent years, the development of biomechanical models is created to analyse the vibration of the PES, but still no uniform results have been achieved that would explain whether the parameters obtained 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 laryngectomized patients

The first aim of this study is to describe phonatory movement of PEM in laryngectomy patients with HSV and then with biomechanical model, analyse these recordings and examine relationship between the obtained parameters and the parameters obtained using the acoustic analysis of the voice of a laryngectomized person. Secondary aim is to assess 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 and to examine whether there is a connection between the parameters obtained from the analysis of acoustic recordings and HSV recordings with the results of the questionnaire i.e., with better or worse postoperative adaptation and satisfaction with the replacement voice.

This is a non-interventional, prospective study of laryngectomised participants who completed oncological treatment and underwent voice rehabilitation. The data will be collected at the Clinical Department for Otorhinolaryngology and Head and Neck Surgery - University Hospital Centre, Osijek, Clinical Department for Otorhinolaryngology and Head and Neck Surgery - University Hospital Centre, Zagreb.

In the first phase of the research, translation and cultural adaptation of a Croatian version of the SECEL questionnaire will be carried out ( ClinicalTrials.gov Identifier: NCT05346237).

Second phase will enrol approximately 50 laryngectomised participants independent from the first phase of research. Data on surgical and oncological treatment, voice rehabilitation method, comorbidities and drug therapy will be collected retrospectively from the patient's medical histories. Ear,nose and throat examination and endoscopic evaluation of swallowing will be performed in order to rule out the presence of non-eligibility criteria. All subjects will fill out a validated questionnaire in Croatian (SECEL:HR). Voice production time will be measured, and subjects will undergo acoustical voice assessment and HSV during voice production. The visualisation of the pharyngoesophageal segment itself will be analysed - phase closure, pharyngoesophageal segment shape (circular, triangular, split side to side, split anterior-posterior, irregular), then the presence and location of visible vibration, and the presence of a mucosal wave. For the processing of HSV videos a computer program will be developed. Based on the collected data, the parameters of the assumed multi-mass coupled biomechanical model will be identified and compared with the acoustic recording of each respondent.

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

Visual recording of the mucosa of the pharyngoesophageal segment will be performed with High speed video endoscopy (Wolf 5562 ENDOCAM) during the phonation of the letter "a". Recording is performed through the mouth with a rigid endoscope connected to an High speed camera.

acoustic program- measuring the quality of voice each laryngectomised patients during phonation of vowel "a". Voice recordings will be analysed in the acoustic program (lingWAVES - Voice and speech analyser)

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

Completing the Croatian version of the 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 development of the biomechanical model of the PES in order to quantify non-stationary PE-vibrations and drawing conclusions on the temporal characteristics of tissue stiffness, oscillating mass, pressure, and geometric distributions within the PE-segment. Biomechanical model will identify mathematical dependencies and analyse extracted time signals of the PES opening and contours which will compare video spectral analysis from high- speed video endoscopy imaging and the parameters obtained using the acoustic analysis of the voice of a laryngectomized person.

Clinical Hospital Centre Zagreb

Josip Juraj Strossmayer University of Osijek

Osijek University Hospital

Behaviors and Mental Disorders

Rare Diseases

Quality of Life

Oculocerebral Syndrome With Hypopigmentation

Patients who have undergone total laryngectomy and completed minimal their 12-month period without disease after surgery and post-operative treatments such as radiotherapy or chemotherapy

Filling out questionnaires, measuring maximum phonation and diadochokinesis

Andrijana Včeva, Prof., Ph.D.

Željka Laksar Klarić

Self-Evaluation of Communication Experiences after Laryngectomy (SECEL) questionnaire has been developed, with the aim of evaluating rehabilitation needs and the psychosocial care for patients with laryngeal cancer. This short but comprehensive self-report instrument measures the perceived adjustment to communication experiences and is intended to aid in determining counselling needs in patients with laryngeal cancer who are treated with a laryngectomy. The first aim of this study is to evaluate the translation, psychometric properties and cultural adaptation of a Croatian version of the SECEL questionnaire. Secondary aim is to examine relationship between the Croatian version of the SECEL and the Short Form Health Survey (SF-36) and the Voice Handicap Index (VHI) questionnaires and to examine relationship between objective voice measures and Self-Evaluation of Communication Experiences after Laryngectomy (SECEL:HR).

At the first visit all patients included in the study were asked to complete the Croatian version of the Voice Handicap Index (VHI), Short Form Health Survey (SF-36) and Self-Evaluation of Communication Experiences after Laryngectomy (SECEL:HR) questionnaire.

SECEL 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). 35 items are grouped according to 3 subscales named General (0-15 score range), Environment (0-42 score range) and Attitude (0-45 score range), and item number 35 is a separate question: "Do you talk the same amount now as before your laryngectomy?" and is rated with a "yes," "more," and "less" rating category. The overall numerical score varies from 0 to 102, and the higher score indicates greater difficulties and worse postoperative speech-communication adjustment.

The Voice Handicap Index (VHI) questionnaire consist of 30 items organized in three subscales functional, physical and emotional and also scored with Likert scale with overall score from 0 to 120. Higher scores indicate a greater handicap.

The Short Form Health Survey (SF-36) is a multi-purpose short-form health survey that consist of 36 questions divided in eight scales and clustered into two groups: physical and mental health. Each item was standardized (range 0-100), with a higher score representing better QoL.

The objective assessment includes the maximum phonation time measured in seconds as common clinical measure of glottal efficiency, diadochokinesis of the 3-syllable "pa-ta-ka" in 5 seconds (rated in syll/s) or how quickly subjects can produce a series of rapid sounds which is a measure of speech efficiency.

All patients will fulfil the SECEL:HR questionnaire twice, two weeks after the initial test and that will be considered as a re-test of the SECEL reliability analysis.

Validation and Cross-cultural Adaptation of Croatian SECEL Questionnaire

Validation and Cross-cultural Adaptation of Croatian Self-Evaluation of Communication Experiences After Laryngectomy Questionnaire

Completing the Croatian version of the Short Form Health Survey (SF-36) questionnaire. The Short Form Health Survey consist of 36 questions divided in eight scales and clustered into two groups: physical and mental health. Each item is standardized (range 0-100), with a higher score representing better QoL.

Completing the Croatian version of the Voice Handicap Index (VHI) questionnaire. The Voice Handicap Index (VHI) questionnaire consist of 30 items organized in three subscales functional, physical and emotional and scored with Likert scale (0-never, 1-almost never, 2-sometimes, 3-almost always, 4-always) with overall score from 0 to 120.

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.

The diadochokinesis measures how quickly an individual can accurately produce a series of rapid sounds of the 3-syllable "pa-ta-ka" in 5 seconds (rated in syll/s) and is a measure of speech efficiency.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Phonatory Movement of the Pharyngoesophageal Mucosa in Laryngectomy Patients	NCT05561920	Larynx Cancer Laryngectomy; S...	High - speed vi... Acoustic voice ... Quality of life...	18 Years - 90 Years	Osijek University Hospital
Validation and Cross-cultural Adaptation of Croatian SECEL Questionnaire	NCT05346237	Larynx Neoplasm Laryngectomy; S... Communication Quality of Life	Quality of life...	18 Years - 90 Years	Osijek University Hospital

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