Determining the Benefits of Improving Communication in BPAP/CPAP Users
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 36
- 试验地点
- 6
- 主要终点
- Accuracy of Single Word Selection (Proportion of Right Words From Total)
研究概览
简要总结
The purpose of this study is to determine the effectiveness of a non-invasive communication aid for BPAP/CPAP masks. This study also looks to determine the potential impact of the device on patients with obstructive sleep apnea (OSA) and the individuals that interact with the device.
详细描述
Noninvasive positive pressure ventilation (NIPPV) is a crucial tool used to treat respiratory distress and failure, especially when patients have acute worsening (also called exacerbations) of emphysema or chronic obstructive pulmonary disease (COPD). This study will randomize patients who use Noninvasive positive pressure ventilation (NIPPV) to a control (non-functioning) and intervention (functioning) device to determine how well speech can be understood while wearing the device.
The purpose of this study is to determine the effectiveness of a non-invasive communication aid for BPAP/CPAP masks. This study also looks to determine the potential impact of the device on patients with obstructive sleep apnea (OSA) and the individuals that interact with the device.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
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
- •Patients must be receiving BPAP/CPAP therapy in the outpatient setting (e.g. clinics, sleep centers).
排除标准
- •Intubated or have a tracheostomy.
- •Vulnerable populations (children, pregnant women, decisionally impaired adults, and prisoners).
- •Speech disabilities, reading disabilities, dyslexia.
结局指标
主要结局
Accuracy of Single Word Selection (Proportion of Right Words From Total)
时间窗: Mask on-communicator on-20 minutes
Data will be collected using audio recording - accuracy of single word selection (spoken by patient -\> selected by partner). The communicator will be attached to the BPAP/CPAP mask. A list of single words will be provided to the patient. Each single word may be read aloud by patient up to two times. The partner must then select the read word out of a list of twelve possible words.
Accuracy of Sentence Selection (Proportion of Right Sentences From Total)
时间窗: Mask on-communicator on-20 minutes
Data will be collected using audio recording - accuracy of sentence selection (spoken by patient -\> transcribed by partner). The communicator will be attached to the BPAP/CPAP mask. A list of 5-word through 15-word sentences will be provided to the patient. Each sentence may be read aloud by patient up to two times. The partner must transcribe each sentence on a standardized form.
次要结局
- Speech Transmission Index (STI)(Mask on with communicator on (20 min))
- Number of Subjects That Found That the Device Significantly Improved Noninvasive Ventilation (NIV) Comfort(Mask on-communicator on-20 minutes)
研究者
Nancy Abbey Collop, MD
Professor
Emory University