Alice PDx User/Validation Extended Trial

NACompletedINTERVENTIONAL
Enrollment

32

Participants

Timeline

Start Date

September 30, 2008

Primary Completion Date

June 30, 2009

Study Completion Date

September 30, 2009

Conditions
Sleep ApneaSleep-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.

Trial Locations (2)

15146

Sleep Center of Greater Pittsburgh, Monroeville

15701

Indiana Regional Medical Center Sleep Disorders Center, Indiana

Sponsors
All Listed Sponsors
lead

Philips Respironics

INDUSTRY