Alice 5 Sleep System User Manual
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.
Used Alice 5 Sleep System Price List
Condition or disease Intervention/treatment Phase Sleep Apnea Sleep-Disordered Breathing Device: Alice PDx with only written instructions Device: Alice PDx with written and verbal instructions Not Applicable. 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. Primary Outcome Measures:. 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. Time Frame: Lab Night. 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. Time Frame: Lab Night. 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.
Time Frame: Lab Night. The Alice PDx incorporates a unique Good Study Indicator (GSI).
Software User Manual
The GSI is a predicated on airflow and oximeter signal quality and displays the amount of 'good quality data' needed for a study to be complete and valid. The GSI visually displays the amount of good quality data in 25-percent increments on the Alice PDx screen. For purposes of this secondary objective this number was compared from participants who set-up and wore the device at home and those that wore the device in a sleep lab set up by a sleep technician.