Alice PDx User/Validation Extended Trial

NCT00841906 | Completed Results

• 1 other identifier: MR-0818-APDxE-MS
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 2

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.

Conditions

Sleep Apnea; Sleep-Disordered Breathing

Outcome Measures

Primary Outcomes (3)

• 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.

  The Apnea-Hypopnea Index (AHI) is an index used to indicate the severity of sleep apnea. It is represented by the number of apnea and hypopnea events per hour of sleep. The AHI detected events of Alice 5 system was compared to the AHI events of the Alice PDx.

  Lab Night

• 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.

  The central apnea index, hypopnea index, mixed apnea index and obstructive apnea indexes are all values that are calculated by determining the type of apneic event (apnea, hypopnea, mixed or obstructive). Each type of event is added up over the night and divided by the number of hours. For this analysis each index was compared between both devices.

  Lab Night

• 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.

  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.

  Lab Night

Secondary Outcomes (1)

• 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.

  Lab Night

Study Arms (2)

Alice PDx with only written instructions

OTHER

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

Alice PDx with written and verbal instructions

OTHER

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

Interventions

Alice PDx with only written instructions DEVICE

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.

Also known as: PDx

Alice PDx with only written instructions

Alice PDx with written and verbal instructions DEVICE

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.

Also known as: PDx

Alice PDx with written and verbal instructions

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Philips Respironics: lead

Study Sites (2)

Indiana Regional Medical Center Sleep Disorders Center

Indiana, Pennsylvania, 15701, United States

Location

Sleep Center of Greater Pittsburgh

Monroeville, Pennsylvania, 15146, United States

Location

MeSH Terms

Conditions

Sleep Apnea Syndromes

Condition Hierarchy (Ancestors)

Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Results Point of Contact

• Title: Sukhdev Grover MD
• Organization: Sleep Center of Greater Pittsburgh

Info@SleepCenterOfGreaterPittsburgh.com

412-681-7771

Study Officials

• Sukhdev Grover, MD

  Sleep Center of Greater Pittsburgh

  PRINCIPAL INVESTIGATOR

• Imran Bajwa, MD

  Indiana Regional Medical Center Sleep Disorders Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 11, 2009
• First Posted: February 12, 2009
• Study Start: September 1, 2008
• Primary Completion: June 1, 2009
• Study Completion: September 1, 2009
• Last Updated: November 19, 2018
• Results First Posted: November 29, 2016

Record last verified: 2018-10

Locations

US (2)