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COMPLETEDNANCT00841906

Alice PDx User/Validation Extended Trial

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 th...

Lead sponsor: Philips Respironics•2 U.S. locations•View source on ClinicalTrials.gov

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Sponsors

Lead Sponsor

Philips Respironics

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.

Age

21 - No limit years

Sex

ALL

Healthy Volunteers

No

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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Data from ClinicalTrials.govLast updated on ClinicalTrials.gov: November 19, 2018Terms

Trial snapshot

StatusCOMPLETED

PhaseNA

Enrollment32

Start dateSep 2008

Last updatedNov 19, 2018

Condition

Sleep Apnea Sleep-Disordered Breathing

Locations shown

Indiana Regional Medical Center Sleep Disorders Center

Indiana, Pennsylvania

Sleep Center of Greater Pittsburgh

Monroeville, Pennsylvania

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: November 19, 2018Data synced to Clareo: May 17, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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