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Alice PDx User/Validation Extended Trial

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ClinicalTrials.gov Identifier: NCT00841906
Recruitment Status : Completed
First Posted : February 12, 2009
Results First Posted : November 29, 2016
Last Update Posted : November 19, 2018
Sponsor:
Information provided by (Responsible Party):
Philips Respironics

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Diagnostic
Conditions Sleep Apnea
Sleep-Disordered Breathing
Interventions Device: Alice PDx with only written instructions
Device: Alice PDx with written and verbal instructions
Enrollment 32
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Alice PDx With Only Written Instructions Alice PDx With Written and Verbal Instructions
Hide Arm/Group Description

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.

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.

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.

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.

Period Title: Overall Study
Started 18 14
Completed 16 14
Not Completed 2 0
Reason Not Completed
Withdrawal by Subject             2             0
Arm/Group Title Alice PDx With Only Written Instructions Alice PDx With Written and Verbal Instructions Total
Hide Arm/Group Description

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.

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.

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.

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.

Total of all reporting groups
Overall Number of Baseline Participants 18 14 32
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 18 participants 14 participants 32 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
16
  88.9%
14
 100.0%
30
  93.8%
>=65 years
2
  11.1%
0
   0.0%
2
   6.3%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 18 participants 14 participants 32 participants
Female
7
  38.9%
9
  64.3%
16
  50.0%
Male
11
  61.1%
5
  35.7%
16
  50.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 18 participants 14 participants 32 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
0
   0.0%
0
   0.0%
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
3
  16.7%
0
   0.0%
3
   9.4%
White
15
  83.3%
14
 100.0%
29
  90.6%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 18 participants 14 participants 32 participants
18 14 32
Body Mass Index  
Mean (Standard Deviation)
Unit of measure:  Kg/m^2
Number Analyzed 18 participants 14 participants 32 participants
35.4  (8.8) 32.6  (6.6) 34.2  (7.9)
Smoking Status  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 18 participants 14 participants 32 participants
Smokers 2 5 7
Non-Smokers 16 9 23
1.Primary Outcome
Title 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.
Hide Description 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.
Time Frame Lab Night
Hide Outcome Measure Data
Hide Analysis Population Description
All participants that completed the overnight portion of the study were analyzed, they each had an Alice 5 System night and an Alice PDx night.
Arm/Group Title Alice 5 System Alice PDx
Hide Arm/Group Description:
All participants in the lab night portion of the study will wear an Alice 5 System and an Alice PDx for comparison of the two devices.
All participants in the lab night portion of the study will wear an Alice 5 System and an Alice PDx for comparison of the two devices.
Overall Number of Participants Analyzed 30 30
Mean (Standard Deviation)
Unit of Measure: events
13.16  (24.69) 20.24  (24.88)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Alice 5 System, Alice PDx
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.001
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
2.Primary Outcome
Title 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.
Hide Description

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.

Time Frame Lab Night
Hide Outcome Measure Data
Hide Analysis Population Description
All participants that completed the overnight portion of the study were analyzed.
Arm/Group Title Alice 5 System Alice PDx
Hide Arm/Group Description:
All participants in the lab night portion of the study will wear an Alice 5 System and an Alice PDx for comparison of the two devices.
All participants in the lab night portion of the study will wear an Alice 5 System and an Alice PDx for comparison of the two devices.
Overall Number of Participants Analyzed 30 30
Mean (Standard Deviation)
Unit of Measure: events/hour
Central Apnea Index .18  (.42) .92  (2.64)
Hypopnea index 6.91  (8.33) 7.15  (4.8)
Mixed Apnea Index .12  (.38) .21  (.52)
Obstructive Apnea Index 5.95  (17.54) 11.97  (21.39)
3.Primary Outcome
Title 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.
Hide Description 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.
Time Frame Lab Night
Hide Outcome Measure Data
Hide Analysis Population Description
All participants that completed the overnight portion of the study were analyzed.
Arm/Group Title Alice 5 System Alice PDx
Hide Arm/Group Description:
All participants in the lab night portion of the study will wear an Alice 5 System and an Alice PDx for comparison of the two devices.
All participants in the lab night portion of the study will wear an Alice 5 System and an Alice PDx for comparison of the two devices.
Overall Number of Participants Analyzed 30 30
Mean (Standard Deviation)
Unit of Measure: minutes
Time In Bed 308.61  (385.32) 178.49  (209.16)
Time spent in Stage N1 5.82  (4.25) 5.43  (2.73)
Time spent in Stage N2 52.50  (13.51) 51.05  (9.59)
Time spent in Stage N3 13.03  (8.61) 13.54  (9.29)
Time spent in Rapid Eye Movement (REM) 12.14  (6.88) 11.74  (5.63)
Sleep Onset Latency 16.98  (15.39) 16.83  (14.35)
Total Sleep Time 319.88  (54.55) 314.93  (58.56)
Wake Time in Bed 16.49  (12.24) 18.23  (12.04)
Wake After Sleep Onset 50.57  (46.5) 55.70  (46.09)
4.Secondary Outcome
Title 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.
Hide Description 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.
Time Frame Lab Night
Hide Outcome Measure Data
Hide Analysis Population Description
3 participants were not able to provide usable GSI data.
Arm/Group Title Alice PDx at Home Alice PDx in the Lab
Hide Arm/Group Description:
All participants set up the Alice PDx at home and in the lab. This is evaluating the Good Study Indicator (GSI) at home.
All participants set up the Alice PDx at home and in the lab. This is evaluating the Good Study Indicator (GSI) in the lab.
Overall Number of Participants Analyzed 27 27
Mean (Standard Deviation)
Unit of Measure: percentage of average GSI
88.9  (17.4) 70.3  (31.1)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Alice PDx With Only Written Instructions Alice PDx With Written and Verbal Instructions
Hide Arm/Group Description

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.

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.

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.

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.

All-Cause Mortality
Alice PDx With Only Written Instructions Alice PDx With Written and Verbal Instructions
Affected / at Risk (%) Affected / at Risk (%)
Total   0/18 (0.00%)      0/14 (0.00%)    
Show Serious Adverse Events Hide Serious Adverse Events
Alice PDx With Only Written Instructions Alice PDx With Written and Verbal Instructions
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/18 (0.00%)      0/14 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Alice PDx With Only Written Instructions Alice PDx With Written and Verbal Instructions
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/18 (5.56%)      0/14 (0.00%)    
Nervous system disorders     
Headache  1  1/18 (5.56%)  1 0/14 (0.00%)  0
1
Term from vocabulary, Headache
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Sukhdev Grover MD
Organization: Sleep Center of Greater Pittsburgh
Phone: 412-681-7771
Responsible Party: Philips Respironics
ClinicalTrials.gov Identifier: NCT00841906     History of Changes
Other Study ID Numbers: MR-0818-APDxE-MS
First Submitted: February 11, 2009
First Posted: February 12, 2009
Results First Submitted: July 13, 2016
Results First Posted: November 29, 2016
Last Update Posted: November 19, 2018