Alice PDx User/Validation Extended Trial
| Status: | Completed |
|---|---|
| Conditions: | Insomnia Sleep Studies, Insomnia Sleep Studies |
| Therapuetic Areas: | Psychiatry / Psychology |
| Healthy: | No |
| Age Range: | 21 - Any |
| Updated: | 11/21/2018 |
| Start Date: | September 2008 |
| End Date: | September 2009 |
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.
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.
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.
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.
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
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