Analyzing voice production in patients who have undergone laryngectomy
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
Osijek University Hospital · NCT05561920
This study is testing how well patients who have had their voice box removed can produce sound and how losing their voice affects their lives.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 52 (estimated) |
| Ages | 18 Years to 90 Years |
| Sex | All |
| Sponsor | Osijek University Hospital (other) |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Osijek) |
| Trial ID | NCT05561920 on ClinicalTrials.gov |
What this trial studies
This observational study aims to investigate the phonatory movement of the pharyngoesophageal mucosa in patients who have had their larynx removed due to cancer. Using high-speed video endoscopy, the study will analyze the vibrations of the reconstructed pharyngoesophageal segment and correlate these findings with acoustic voice analysis. Additionally, it will assess the psychological and socioeconomic impacts of voice loss on these patients through a validated questionnaire. The study will involve approximately 50 participants who have completed their oncological treatment and are undergoing voice rehabilitation.
Who should consider this trial
Good fit: Ideal candidates are laryngectomized patients who have completed at least six months without disease after surgery and post-operative treatments.
Not a fit: Patients under 18 years old or those with acute respiratory infections or other primary cancers in the upper aerodigestive tract may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance understanding of voice rehabilitation techniques for laryngectomized patients, leading to improved communication outcomes.
How similar studies have performed: While there have been studies on voice rehabilitation, this specific approach combining high-speed video endoscopy with acoustic analysis is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Osijek
- University Hospital Osijek — Osijek, Croatia (RECRUITING)
Study contacts
- Study coordinator: Željka Laksar Klarić, M.D.
- Email: zeljka.l.klaric@mail.com
- Phone: +38598666494
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Larynx Cancer, Laryngectomy, Status, Endoscopy, Speech,acoustics, High speed imaging, Speech,alaryngeal, Pharyngoesophageal segment