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Development and clinical application of personalized AI voice cloning system for patients with laryngeal malignant tumors: a single blind parallel controlled trial

Development and clinical application of personalized AI voice cloning system for patients with laryngeal malignant tumors: a single blind parallel controlled trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500114416
Enrollment
Unknown
Registered
2025-12-11
Start date
2026-01-01
Completion date
Unknown
Last updated
2025-12-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Laryngocarcinoma

Interventions

Trial group: Software name - New Voice Protection Language:During the first week after hospitalization, the instructional nurse will guide participants in querying, downloading, accessing, and registe
if any details are missed or errors occur, the nurse will provide immediate assistance until the participant fully masters the procedures. For the XinSheng HuYu software group, usage began in the fir
Control group: General-purpose software (Software name: Text-to-Speech):During the first week after hospitalization, the instructional nurse will guide participants in searching for, downloading, acce
if any details are omitted or errors occur, the nurse will provide immediate support until the participant achieves full mastery. For the Text-to-Speech software group, usage began in the first week

Sponsors

Xinhua Hospital Affiliated to Shanghai Jiaotong University School of Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
50 Years to 60 Years

Inclusion criteria

Inclusion criteria: 1.Patients undergoing surgery for laryngeal malignant tumors; 2.Voluntary cooperation and participation; 3.Psychologically and mentally normal (1 point on the Symptom Checklist 90); 4.Postoperative establishment of artificial airway for patients; 5.Electronic devices: smartphones with Android and Apple operating systems; 6.Sign the informed consent form.

Exclusion criteria

Exclusion criteria: 1.Not willing to participate; 2.Not undergoing partial or total laryngectomy; 3.Individuals with mental illness or cognitive impairment; 4.Individuals with hearing impairments or other neurological disorders who are unable to complete follow-up; 5.Elderly mobile phones with only call function and no smart interface on patient electronic devices and unwilling to use hospital provided electronic devices.

Design outcomes

Primary

MeasureTime frame
Voice MOS Evaluation Form;Self-Assessment Questionnaire on Communication Experience After Laryngectomy;

Secondary

MeasureTime frame
Patient Depression Assessment Scale;Anxiety Screening Scale;Quality of Life Scale for Head and Neck Cancer Patients;Patient and Family Satisfaction AssessmentPatient and Family Satisfaction Assessment Form;Social Support Rating Scale;

Countries

China

Contacts

Public ContactBai Yajin

Xinhua Hospital Affiliated to Shanghai Jiaotong University School of Medicine

baiyajin@xinhuamed.com.cn+86 136 2165 3845

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026