Phonatory Movement of the Pharyngoesophageal Mucosa in Laryngectomy Patients

Larynx Cancer Clinical Trial

Official 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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05561920
• Other study ID #: OsijekUH-HS camera
• Status: Recruiting
• Start date: August 1, 2022
• Est. completion date: October 2024

Study information

• Verified date: January 2024
• Source: Osijek University Hospital
• Contact: Željka Laksar Klaric, M.D.
• Phone: +38598666494
• Email: zeljka.l.klaric[@]mail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 52
• Est. completion date: October 2024
• Est. primary completion date: May 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Laryngeal Neoplasms
• Laryngectomy; Status
• Larynx Cancer

Intervention

Device:
• High - speed video endoscopy (HSV)
Describe anatomical and morphological characteristics o phonatory movement of PEM in laryngectomy patients
• 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

Locations

Country	Name	City	State
Croatia	University Hospital Osijek	Osijek

Sponsors (3)

Lead Sponsor	Collaborator
Osijek University Hospital	Clinical Hospital Centre Zagreb, Josip Juraj Strossmayer University of Osijek

Country where clinical trial is conducted

Croatia, 

References & Publications (9)

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. — View 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. — View 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. — View Citation

Matev B, Asenov A, Stoyanov GS, Nikiforova LT, Sapundzhiev NR. Losing One's Voice to Save One's Life: A Brief History of Laryngectomy. Cureus. 2020 Jun 24;12(6):e8804. doi: 10.7759/cureus.8804. — View 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. — View 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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	High speed video endoscopy recordings	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.	15 minutes for each participants
Primary	Acoustic analysis	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)	15 minutes
Primary	Maximum phonation time	Measurement of the longest possible relaxed phonation of the voice "a" by a speech therapist	2 minutes
Primary	Croatian version of the SECEL (SECEL:HR) questionnaire.	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)	15 minutes
Primary	Development of Biomechanical model for vibration analysis obtained by High - speed video endoscopy	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.	3 months