Phonatory Movement of the Pharyngoesophageal Mucosa in Laryngectomy Patients

Trial Title: Phonatory Movement of the Pharyngoesophageal Mucosa in Laryngectomy Patients

NCT ID: NCT05561920

Condition: Larynx Cancer
Laryngectomy; Status

Conditions: Official terms:
Laryngeal Neoplasms

Conditions: Keywords:
Laryngectomy
Endoscopy
Speech,acoustics
High speed imaging
Speech,alaryngeal
Pharyngoesophageal segment
Biomechanics model

Study type: Observational

Overall status: Recruiting

Study design:

Time perspective: Prospective

Intervention:

Intervention type: Device
Intervention name: High - speed video endoscopy (HSV)
Description: Describe anatomical and morphological characteristics o phonatory movement of PEM in laryngectomy patients
Arm group label: Adult laryngectomised patients

Intervention type: Device
Intervention name: Acoustic voice analysis
Description: acoustic program (lingWAVES - Voice and speech analyser) - measuring the values of acoustic parameters in voice recordings
Arm group label: Adult laryngectomised patients

Intervention type: Behavioral
Intervention name: Quality of life questionnaire
Description: Filling out questionnaires
Arm group label: Adult laryngectomised patients

Summary: 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

Detailed description: 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.

Criteria for eligibility:

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

Sampling method: Probability Sample
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

Gender: All

Minimum age: 18 Years

Maximum age: 90 Years

Healthy volunteers: No

Locations:

Facility:
Name: University Hospital Osijek

Address:
City: Osijek
Zip: 31000
Country: Croatia

Status: Recruiting

Contact:
Last name: Željka Laksar Klarić, M.D.

Phone: +38598666494
Email: zeljka.l.klaric@gmail.com

Start date: August 1, 2022

Completion date: May 2025

Lead sponsor:
Agency: Osijek University Hospital
Agency class: Other

Collaborator:
Agency: Josip Juraj Strossmayer University of Osijek
Agency class: Other

Source: Osijek University Hospital

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT05561920