Alice PDx User/Validation Extended Trial

Summary

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.

Conditions

• Sleep Apnea
• Sleep-Disordered Breathing

Interventions

DEVICE

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. After the Alice PDx home study has proven successful, participants will return to the sleep center to undergo a second sleep study, the Lab Night, in which simultaneous monitoring with the Alice PDx and Alice 5 will be performed.

DEVICE

Alice PDx with written and verbal instructions

Participants will be provided instruction by a trained sleep professional on the set up of the Alice PDx device. They will then be asked to follow the instructions for the Alice PDx device, if necessary, and undergo a sleep study in their home. After the Alice PDx home study has proven successful, participants will return to the sleep center to undergo a second sleep study, the Lab Night, in which simultaneous monitoring with the Alice PDx and Alice 5 will be performed.

Sponsors & Collaborators

• Philips Respironics

  lead INDUSTRY

Principal Investigators

• Sukhdev Grover, MD · Sleep Center of Greater Pittsburgh

• Imran Bajwa, MD · Indiana Regional Medical Center Sleep Disorders Center

Study Design

Allocation

RANDOMIZED

Purpose

DIAGNOSTIC

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

21 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2008-09-30

Primary Completion

2009-06-30

Completion

2009-09-30

Countries

• United States

Study Locations