A Pilot Study for a Novel and Personalized Voice Restoration Device for Patients With Laryngectomy
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Subject experience with voice restoration devices: Qualitative
研究概览
简要总结
The investigators will conduct a pilot experiment for a novel and personalized method for voice restoration using machine learning applied to surface EMG (sEMG) signal from articulatory muscles of the face and the neck allowing recognition of silent speech. The investigators predict that the use novel personalized method for voice restoration will be feasible and successful for patients.
详细描述
This is a prospective pilot study evaluating the feasibility of a personalized voice restoration device and patients' experience with it. Study participation will include a one-time visit where subjects will read passages and phrases. Acoustic and signal data will be captured. Machine learning will be applied to the data to classify words. Subjects will also participate in a qualitative interview about their experience with voice restoration devices.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 110 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Group A: Healthy Volunteers
- •Adult subjects, 18 or older
- •Without any voice impairments
- •Group B: Subjects with Aphonia or Dysphonia
- •Adult subjects, 18 or older
- •Documentation of severe dysphonia and/or aphonia, or a GRBAS score > 0 (GRBAS is a scale that can be used to assess voice quality of subjects who do not have a recorded history of dysphonia or aphonia. The GRBAS scale evaluates for grade, roughness, breathiness, asthenia, and strain).
排除标准
- •- Group A: Healthy Volunteers
- •1. Voice impairment
- •Group B: Subjects with Aphonia or Dysphonia
- •1. Subjects whose face muscles are entirely paralyzed
研究组 & 干预措施
Patients with Aphonia or Dysphonia
Participants with Aphonia or Dysphonia will be asked to recite phrases with sEMG attached to articulatory muscles.
干预措施: Surface Electromyography (Device)
Healthy Volunteers
Healthy Volunteer will be asked to recite phrases with sEMG attached to articulatory muscles.
干预措施: Surface Electromyography (Device)
结局指标
主要结局
Subject experience with voice restoration devices: Qualitative
时间窗: 10 minutes after the time of intervention
Subject will be asked to complete a semi-structured interview about their experience with voice restoration devices. Categories of response include voice/communication history, experience with previous voice restoration devices, experience with our device, and suggestions for improvement.
Percentage of Words and Numbers Correctly Identified
时间窗: "During Procedure/use of Surface ElectroMyoGraphy"
Accuracy of sEMG signal will be determined by subjects reciting common phrases. Subjects will recite the "Rainbow Passage" 10 times. Subjects will be asked to count from 1-10 once. Subjects will recite the alphabet once.
次要结局
未报告次要终点