Phonatory Movement of the Pharyngoesophageal Mucosa in Laryngectomy Patients
NCT ID: NCT05561920
Last Updated: 2024-09-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
52 participants
OBSERVATIONAL
2022-08-01
2025-05-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Adult laryngectomised patients
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
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
Quality of life questionnaire
Filling out questionnaires
Interventions
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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
Quality of life questionnaire
Filling out questionnaires
Eligibility Criteria
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Inclusion Criteria
* patients with preserved reading skills
* regular presence at follow-up visits
Exclusion Criteria
* 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
18 Years
90 Years
ALL
No
Sponsors
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Josip Juraj Strossmayer University of Osijek
OTHER
Osijek University Hospital
OTHER
Responsible Party
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Principal Investigators
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Ana Đanić Hadžibegović, Assoc. Prof
Role: STUDY_CHAIR
Clinical Hospital Centre Zagreb
Andrijana Včeva, Full Prof
Role: STUDY_CHAIR
University Hospital Osijek
Locations
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University Hospital Osijek
Osijek, Osijek, Croatia
Countries
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Central Contacts
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Facility Contacts
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References
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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.
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.
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.
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.
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.
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.
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.
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.
Other Identifiers
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OsijekUH-HS camera
Identifier Type: -
Identifier Source: org_study_id
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