Alice PDx User/Validation Extended Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 32
- 试验地点
- 4
- 主要终点
- This Study Will Compare the Apnea Hypopnea Index Recorded by the Alice PDx to the Physiological Data Recorded by Its Predicate Device the Alice 5 System and Validate Its Equivalence.
研究概览
简要总结
The objective of this study is to test the usability of the Alice PDx device by both the end user (patient/participant) and the sleep technician. Data will be collected via questionnaires regarding the participant's ability to understand the participant user manual under home conditions and the technician's ability to set up the Alice PDx according to the health care provider manual. This study will also compare the physiological data recorded by the Alice PDx to the physiological data recorded by its predicate device the Alice 5 System and validate its equivalence. This will be evaluated by comparing the manual study scores for detected apnea and hypopnea events and on an event by event basis during a standard polysomnography (PSG)/ sleep study. The study will test the ability of the Alice PDx to record good quality data as determined by the Good Study Indicator (GSI) function of the Alice PDx firmware.
The primary hypothesis is that the participant will be able to successfully apply the Alice PDx basic leads following the participant user manual instructions and the sleep technician will be able to successfully apply the advanced leads in preparation for the sleep study. In addition, it will be demonstrated that the Alice PDx is equivalent to the Alice 5 System in its intent to record, display and print physiological data to the clinician/physician in order to aid in the screening/follow-up diagnosis of respiratory sleep disorders.
详细描述
Alice PDx is a portable, diagnostic recording device. It may be used for obstructive sleep screening as well as follow-up and diagnostic assessment. The device may be used in a sleep lab or clinical setting by trained professionals and it may be used at home by patients as directed by their health care provider. The Alice PDx device is not currently approved by the Food and Drug Administration (FDA).
The Alice PDx device is capable of recording various physiological inputs and storing the data locally on a removable storage card. The device may also be connected directly to a PC (personal computer) running the Alice Sleepware software application. Sleepware can display live or pre-recorded data in a resolution consistent with the computer hardware specifications.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients must call into a sleep lab or be referred to a sleep lab for a diagnostic polysomnogram
- •Able to follow directions
- •Able to provide informed consent
排除标准
- •Participants requiring supplemental oxygen therapy
- •History of having a previous sleep study/polysomnogram performed
- •Current positive airway pressure (PAP) users
- •Unable or unwilling to perform a polysomnogram
研究组 & 干预措施
Alice PDx with only written instructions
Participants will be asked to follow the Alice PDx user instructions to apply basic leads and sensors and undergo a sleep study in their home. Participants will receive little or no instruction concerning the set up of the Alice PDx device.
干预措施: Alice PDx with only written instructions (Device)
Alice PDx with written and verbal instructions
Participants will be asked to follow the Alice PDx user instructions to apply basic leads and sensors and undergo a sleep study in their home. Participants will receive little or no instruction concerning the set up of the Alice PDx device.
干预措施: Alice PDx with written and verbal instructions (Device)
结局指标
主要结局
This Study Will Compare the Apnea Hypopnea Index Recorded by the Alice PDx to the Physiological Data Recorded by Its Predicate Device the Alice 5 System and Validate Its Equivalence.
时间窗: Lab Night
The Apnea-Hypopnea Index (AHI) is an index used to indicate the severity of sleep apnea. It is represented by the number of apnea and hypopnea events per hour of sleep. The AHI detected events of Alice 5 system was compared to the AHI events of the Alice PDx.
This Study Will Compare the Central Apnea Index, Hypopnea Index, Mixed Apnea Index and Obstructive Apnea Index Recorded by the Alice PDx to the Physiological Data Recorded by Its Predicate Device the Alice 5 System and Validate Its Equivalence.
时间窗: Lab Night
The central apnea index, hypopnea index, mixed apnea index and obstructive apnea indexes are all values that are calculated by determining the type of apneic event (apnea, hypopnea, mixed or obstructive). Each type of event is added up over the night and divided by the number of hours. For this analysis each index was compared between both devices.
This Study Will Compare Different Measurements Recorded by the Alice PDx to the Measurement Data Recorded by Its Predicate Device the Alice 5 System and Validate Its Equivalence.
时间窗: Lab Night
This study will compare different measurements recorded which include Time in Bed, Stage N1, Stage N2, Stage N3, REM, Sleep Onset Latency, Total Sleep Time, Wake Time in Bed and Wake After Sleep Onset by the Alice PDx to the measurement data recorded by its predicate device the Alice 5 System and validate its equivalence.
次要结局
- The Secondary Objective of This Study is to Compare the Measurements of the Alice PDx When Patients Complete the Set-up of the Device at Home and When Patients Are Set up by a Sleep Technician in the Sleep Laboratory.(Lab Night)