Evaluation of a Disposable Hands-Free Heat and Moisture Exchanger (HME) Valve: The Blom-Singer SpeakFree HME Hands Free Valve
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 18
- 试验地点
- 2
- 主要终点
- Satisfaction as measured by VAS
研究概览
简要总结
The purpose of the study is to evaluate the new Blom-Singer SpeakFree disposable hands free valve heat and moisture exchanger (HME). The investigators will compare the SpeakFree to other modalities of stomal occlusion (digital occlusion and digital depression of an HME) for patients who communicate with a voice prosthesis as determined by patient preference and satisfaction. In addition, the investigators will compare the SpeakFree to other modalities of stomal occlusion as determined by objective measures of speech and voice parameters (maximum phonation time, syllables per breath, minimum/maximum phonation pressures, and a clinician rating of voice quality using a visual analog scale).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participants who have undergone a total laryngectomy who have and use a voice prosthesis as their primary form of communication for at least 3 months prior to study enrollment.
- •Participants must have had at least 2 voice prosthesis management visits from a speech pathologist at the University of Miami prior to study enrollment.
- •Participants must have fully healed suture lines.
- •Participants must demonstrate fluent tracheoesophageal speech (i.e., maximum phonation time of at least 5 seconds during 3 consecutive trials)
- •Current HME use for a minimum of 1 month
- •Participants willing to complete the survey and provide a signed Informed Consent Form
- •Males and non-pregnant females over the age of 18
排除标准
- •Participants who do not have a voice prosthesis.
- •Participants who have dysarthria.
- •Participants who are currently receiving treatment for head and neck cancer.
- •Participants who have an underlying neurologic condition potentially impacting speech.
结局指标
主要结局
Satisfaction as measured by VAS
时间窗: Up to 1 month
Patient preference and satisfaction will be measured using a visual Analog Scale (VAS) ranging in score from 1-10 with a higher score indicating greater satisfaction with the device.
Voice Quality: Patient Rating
时间窗: Up to 1 month
Voice Quality will be measured using a visual Analog Scale ranging in score from 1-10 with a higher score indicating that the patient feels their voice quality is better with the device.
次要结局
- Change in Maximum Phonation Time(Baseline, 1 month)
- Change in Syllables Per Breath(Baseline, 1 month)
- Change in Voice Quality: Clinician Rating(Baseline, 1 month)
- Pressure Needed to Phonate(Baseline)
研究者
Mario Alberto Landera, SLP.D
Associate Professor of Clinical
University of Miami