NCT05348031

Brief Summary

This study intends to collect clinical data such as strobary laryngoscope images and vowel audio data of patients with structural voice disorders and healthy individuals, and to establish a multimodal voice disorder diagnosis system model by using deep learning algorithms. Multi-classification of diseases that cause voice disorders can be applied to patients with voice disorders but undiagnosed in clinical practice, thereby assisting clinicians in diagnosing diseases and reducing misdiagnosis and missed diagnosis. In addition, some patients with voice disorders can be managed remotely through the audio diagnosis model, and better follow-up and treatment suggestions can be given to them. Remote voice therapy can alleviate the current situation of the shortage of speech therapists in remote areas of our country, and increase the number of patients who need voice therapy. opportunity. Remote voice therapy is more cost-effective, more flexible in time, and more cost-effective.

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1

participants targeted

Target at below P25 for all trials

Timeline
9mo left

Started May 2022

Longer than P75 for all trials

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress84%
May 2022Feb 2027

First Submitted

Initial submission to the registry

April 19, 2022

Completed
8 days until next milestone

First Posted

Study publicly available on registry

April 27, 2022

Completed
9 days until next milestone

Study Start

First participant enrolled

May 6, 2022

Completed
3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2025

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

February 20, 2027

Expected
Last Updated

April 27, 2022

Status Verified

March 1, 2022

Enrollment Period

3.7 years

First QC Date

April 19, 2022

Last Update Submit

April 22, 2022

Conditions

Keywords

deep learningmultimodalitystructural voice disordersstroboscopic laryngoscope videoSpeech

Outcome Measures

Primary Outcomes (3)

  • Machine deep learning classifies vocie disorders

    Accuracy

    May 6,2022-December 30,2023

  • Machine deep learning classifies vocie disorders witn multimodality

    precision

    January 1,2024-December 30,2024

  • Machine deep learning classifies pathological voice change in Laryngeal Cancer

    precision

    January 1,2024-December 30,2025

Secondary Outcomes (1)

  • Machine deep learning classifies vocie disorders witn multimodality

    January 1,2024-December 30,2025

Eligibility Criteria

Age20 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

In this study, 490 patients with voice disorders (including laryngeal cancer, laryngeal precancerous lesions, and benign laryngeal lesions) and 50 healthy people were collected from stroboscopic laryngoscopy videos and vowel audio recordings. Gender, course of disease, VHI and other clinical data.

You may qualify if:

  • Laryngeal cancer, laryngeal precancerous lesions, benign laryngeal lesions with voice disorders, healthy people without throat diseases

You may not qualify if:

  • A history of laryngeal surgery
  • Patients with voice disorders caused by various causes except laryngeal cancer, laryngeal precancerous lesions, and benign laryngeal lesions
  • The audio quality is not clear, the stroboscopic laryngoscope does not clearly display the anatomical area related to the glottis, and it is underexposed and blocked;

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (12)

  • Martínez, David, Lleida Eduardo, Ortega Alfonso,Miguel Antonio, Villalba Jesús. Voice pathology detection on the Saarbrücken voice database with calibration and fusion of scores using multifocal toolkit. Advances in Speech and Language Technologies for Iberian Languages. Springer, Berlin, Heidelberg, 2012. 99-109

    BACKGROUND
  • Hegde S, Shetty S, Rai S, Dodderi T. A Survey on Machine Learning Approaches for Automatic Detection of Voice Disorders. J Voice. 2019 Nov;33(6):947.e11-947.e33. doi: 10.1016/j.jvoice.2018.07.014. Epub 2018 Oct 11.

    PMID: 30316551BACKGROUND
  • Al-Nasheri A, Muhammad G, Alsulaiman M, Ali Z. Investigation of Voice Pathology Detection and Classification on Different Frequency Regions Using Correlation Functions. J Voice. 2017 Jan;31(1):3-15. doi: 10.1016/j.jvoice.2016.01.014. Epub 2016 Mar 15.

    PMID: 26992554BACKGROUND
  • .Chuang, ZY,YuXT,Chen JY, Hsu YT,Xu ZZ,Wang CT,Lin FC,Fang SH. DNN-based approach to detect and classify pathological voice. In Proceedings of the 2018 IEEE International Conference on Big Data (Big Data), Seattle, WA, USA, 10-13 December 2018

    BACKGROUND
  • Fang SH, Tsao Y, Hsiao MJ, Chen JY, Lai YH, Lin FC, Wang CT. Detection of Pathological Voice Using Cepstrum Vectors: A Deep Learning Approach. J Voice. 2019 Sep;33(5):634-641. doi: 10.1016/j.jvoice.2018.02.003. Epub 2018 Mar 19.

    PMID: 29567049BACKGROUND
  • Bethani Gty As H , Suwandi, Anggraini C D . Classification System Vocal Cords Disease Using Digital Image Processing.The 2019 IEEE International Conference on industry 4.0,Artifical Intelligence,and Communications Technology.2019.129-132

    BACKGROUND
  • Unger J, Lohscheller J, Reiter M, Eder K, Betz CS, Schuster M. A noninvasive procedure for early-stage discrimination of malignant and precancerous vocal fold lesions based on laryngeal dynamics analysis. Cancer Res. 2015 Jan 1;75(1):31-9. doi: 10.1158/0008-5472.CAN-14-1458. Epub 2014 Nov 4.

    PMID: 25371410BACKGROUND
  • Xiong H, Lin P, Yu JG, Ye J, Xiao L, Tao Y, Jiang Z, Lin W, Liu M, Xu J, Hu W, Lu Y, Liu H, Li Y, Zheng Y, Yang H. Computer-aided diagnosis of laryngeal cancer via deep learning based on laryngoscopic images. EBioMedicine. 2019 Oct;48:92-99. doi: 10.1016/j.ebiom.2019.08.075. Epub 2019 Oct 5.

    PMID: 31594753BACKGROUND
  • Kim H, Jeon J, Han YJ, Joo Y, Lee J, Lee S, Im S. Convolutional Neural Network Classifies Pathological Voice Change in Laryngeal Cancer with High Accuracy. J Clin Med. 2020 Oct 25;9(11):3415. doi: 10.3390/jcm9113415.

    PMID: 33113785BACKGROUND
  • Godino-Llorente JI, Gomez-Vilda P. Automatic detection of voice impairments by means of short-term cepstral parameters and neural network based detectors. IEEE Trans Biomed Eng. 2004 Feb;51(2):380-4. doi: 10.1109/TBME.2003.820386.

    PMID: 14765711BACKGROUND
  • Ren J, Jing X, Wang J, Ren X, Xu Y, Yang Q, Ma L, Sun Y, Xu W, Yang N, Zou J, Zheng Y, Chen M, Gan W, Xiang T, An J, Liu R, Lv C, Lin K, Zheng X, Lou F, Rao Y, Yang H, Liu K, Liu G, Lu T, Zheng X, Zhao Y. Automatic Recognition of Laryngoscopic Images Using a Deep-Learning Technique. Laryngoscope. 2020 Nov;130(11):E686-E693. doi: 10.1002/lary.28539. Epub 2020 Feb 18.

    PMID: 32068890BACKGROUND
  • Bainbridge KE, Roy N, Losonczy KG, Hoffman HJ, Cohen SM. Voice disorders and associated risk markers among young adults in the United States. Laryngoscope. 2017 Sep;127(9):2093-2099. doi: 10.1002/lary.26465. Epub 2016 Dec 23.

MeSH Terms

Conditions

Voice DisordersSpeech

Condition Hierarchy (Ancestors)

Laryngeal DiseasesRespiratory Tract DiseasesOtorhinolaryngologic DiseasesNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsVerbal BehaviorCommunicationBehavior

Study Officials

  • YueXin Cai

    Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

    STUDY CHAIR

Central Study Contacts

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 19, 2022

First Posted

April 27, 2022

Study Start

May 6, 2022

Primary Completion

December 30, 2025

Study Completion (Estimated)

February 20, 2027

Last Updated

April 27, 2022

Record last verified: 2022-03