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Alice PDx User/Validation Extended Trial

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Philips Respironics
ClinicalTrials.gov Identifier:
NCT00841906
First received: February 11, 2009
Last updated: October 5, 2016
Last verified: October 2016
  Purpose

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.


Condition Intervention
Sleep Apnea
Sleep-Disordered Breathing
Device: Alice PDx with only written instructions
Device: Alice PDx with written and verbal instructions

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Alice PDx User/Validation Extended Trial

Further study details as provided by Philips Respironics:

Primary Outcome Measures:
  • This Study Will Compare the Apnea Hypopnea Index Recorded by the Alice PDx to the Physiological Data Recorded by Its Predicate Device the Alice 5 System and Validate Its Equivalence. [ Time Frame: Lab Night ] [ Designated as safety issue: No ]
  • This Study Will Compare the Central Apnea Index, Hypopnea Index, Mixed Apnea Index and Obstructive Apnea Index Recorded by the Alice PDx to the Physiological Data Recorded by Its Predicate Device the Alice 5 System and Validate Its Equivalence. [ Time Frame: Lab Night ] [ Designated as safety issue: No ]
  • This Study Will Compare Different Measurements Recorded by the Alice PDx to the Measurement Data Recorded by Its Predicate Device the Alice 5 System and Validate Its Equivalence. [ Time Frame: Lab Night ] [ Designated as safety issue: No ]
    This study will compare different measurements recorded which include Time in Bed, Stage N1, Stage N2, Stage N3, REM, Sleep Onset Latency, Total Sleep Time, Wake Time in Bed and Wake After Sleep Onset by the Alice PDx to the measurement data recorded by its predicate device the Alice 5 System and validate its equivalence.


Secondary Outcome Measures:
  • The Secondary Objective of This Study is to Compare the Measurements of the Alice PDx When Patients Complete the Set-up of the Device at Home and When Patients Are Set up by a Sleep Technician in the Sleep Laboratory. [ Time Frame: overnight ] [ Designated as safety issue: No ]
    The Alice PDx incorporates a unique Good Study Indicator (GSI). The GSI is a predicated on airflow and oximeter signal quality and displays the amount of "good quality data" needed for a study to be complete and valid. The GSI visually displays the amount of good quality data in 25-percent increments on the Alice PDx screen. For purposes of this secondary objective this number was compared from participants who set-up and wore the device at home and those that wore the device in a sleep lab set up by a sleep technician.


Enrollment: 30
Study Start Date: September 2008
Study Completion Date: September 2009
Primary Completion Date: June 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
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.
Other Name: PDx
Alice PDx with written and verbal 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.
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.
Other Name: PDx

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   21 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00841906

Locations
United States, Pennsylvania
Indiana Regional Medical Center Sleep Disorders Center
Indiana, Pennsylvania, United States, 15701
Sleep Center of Greater Pittsburgh
Monroeville, Pennsylvania, United States, 15146
Sponsors and Collaborators
Philips Respironics
Investigators
Principal Investigator: Sukhdev Grover, MD Sleep Center of Greater Pittsburgh
Principal Investigator: Imran Bajwa, MD Indiana Regional Medical Center Sleep Disorders Center
  More Information

Responsible Party: Philips Respironics
ClinicalTrials.gov Identifier: NCT00841906     History of Changes
Other Study ID Numbers: MR-0818-APDxE-MS 
Study First Received: February 11, 2009
Results First Received: July 13, 2016
Last Updated: October 5, 2016
Health Authority: United States: Institutional Review Board

ClinicalTrials.gov processed this record on December 05, 2016