Alice PDx User/Validation Extended Trial

Philips

Status: Completed

Conditions: Sleep Apnea; Sleep-Disordered Breathing

Treatments: Device: Alice PDx with written and verbal instructions; Device: Alice PDx with only written instructions

Study type: Interventional

Funder types: Industry

Identifiers

NCT00841906

MR-0818-APDxE-MS

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 32 patients

Sex: All

Ages: 21+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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32 participants in 2 patient groups

Alice PDx with only written instructions

Other group

Description:

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.

Treatment:

Device: Alice PDx with only written instructions

Alice PDx with written and verbal instructions

Other group

Description:

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.

Treatment:

Device: Alice PDx with written and verbal instructions