Clinical trial NCT00841906: Alice PDx User/Validation Extended Trial
Official title: Alice PDx User/Validation Extended Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sleep Apnea
Sleep-Disordered Breathing
Lead sponsor: Philips Respironics
Sponsor class: INDUSTRY
First posted: 2009-02-12
Enrollment: 32
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief 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.

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 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

Primary outcomes:
measure: 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.
timeFrame: Lab Night
measure: 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.
timeFrame: Lab Night
measure: 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.
timeFrame: Lab Night
Secondary outcomes:
measure: 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.
timeFrame: Lab Night
Other outcomes:
Locations:
city: Indiana
country: United States
facility: Indiana Regional Medical Center Sleep Disorders Center
state: Pennsylvania
city: Monroeville
country: United States
facility: Sleep Center of Greater Pittsburgh
state: Pennsylvania
Study officials:
affiliation: Sleep Center of Greater Pittsburgh
name: Sukhdev Grover, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Indiana Regional Medical Center Sleep Disorders Center
name: Imran Bajwa, MD
role: PRINCIPAL_INVESTIGATOR
References: