Alice PDx User/Validation Extended Trial

ClinicalTrials.gov ID: NCT00841906

Public ClinicalTrials.gov record NCT00841906. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

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Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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.

Study identification

NCT ID: NCT00841906
Recruitment status: Completed
Study type: Interventional
Phase: Not applicable
Lead sponsor: Philips Respironics; Industry
Enrollment: 32 participants

Conditions and interventions

Conditions

Interventions

Device

Eligibility (public fields only)

Age range: 21 Years and older
Sex: All
Healthy volunteers: Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date: Aug 31, 2008
Primary completion: May 31, 2009
Completion: Aug 31, 2009
Last update posted: Nov 18, 2018

2008 – 2009

United States locations

U.S. sites: 2
U.S. states: 1
U.S. cities: 2

Facility	City	State	ZIP	Site status
Indiana Regional Medical Center Sleep Disorders Center	Indiana	Pennsylvania	15701	—
Sleep Center of Greater Pittsburgh	Monroeville	Pennsylvania	15146	—

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows: Public field values for ClinicalTrials.gov record NCT00841906, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do: No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from: Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh: Last update posted Nov 18, 2018 · Synced Sep 2, 2026

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The complete protocol, eligibility criteria, and contact information for NCT00841906 live on ClinicalTrials.gov.

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