Alice PDx User/Validation Extended Trial

Completed · Not applicable

Conditions studied: Sleep Apnea, Sleep-Disordered Breathing

In brief

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.

Key facts

Study ID

NCT00841906

Run by

Philips Respironics

People needed

32

Starts

2008-09-01

Expected to finish

2009-09-01

Last updated by the study team

2018-11-19

Who can join

Age: 21 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Indiana Regional Medical Center Sleep Disorders Center — Indiana, Pennsylvania, United States
• Sleep Center of Greater Pittsburgh — Monroeville, Pennsylvania, United States

Full record on ClinicalTrials.gov

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