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NCT00841906 · ClinicalTrials.gov registry record · NA
Alice PDx User/Validation Extended Trial
A NA study, sponsored by Philips Respironics.
- Completed
- Registry status
- NA
- Development phase
- 32
- Enrollment target
NCT00841906 is a NA study that has completed, run by Philips Respironics. The registered enrollment target is 32 participants.
The verdict
NCT00841906, a NA study, has completed, sponsored by Philips Respironics.
- COMPLETED
- Registry status
- NA
- Development phase
- 32 participants
- Enrollment target
Study 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.
Interventions
- DEVICE Alice PDx with only written instructions
- DEVICE Alice PDx with written and verbal instructions
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 32 participants |
| Start Date | 2008-09 |
| Est. Completion | 2009-09 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00841906
The ClinicalTrials.gov registry entry for NCT00841906 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 32 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Philips Respironics, which has 35 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Alice PDx with only written instructions is the first listed.
NCT00841906 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00841906 about?
NCT00841906 is a clinical study titled "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 the participant's ability to understand the participant user manual under home conditions and the tech...
What is the current status of trial NCT00841906?
This trial is currently completed. It is a NA study. The enrollment target is 32 participants. The study started on 2008-09. Estimated completion is 2009-09.
What interventions are being tested in trial NCT00841906?
The interventions under investigation include: Alice PDx with only written instructions (DEVICE), Alice PDx with written and verbal instructions (DEVICE).
Who is sponsoring clinical trial NCT00841906?
This trial is sponsored by Philips Respironics, which has 35 total clinical trials registered on ClinicalTrials.gov.
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