N/A
Completed N=32
Alice PDx User/Validation Extended Trial
Source: ClinicalTrials.gov NCT00841906 ↗Enrolled (actual)
32
Serious AEs
0.0%
Results posted
Nov 2016
Primary outcomePrimary: 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. — 13.16; 20.24 events — p=< 0.001
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY 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. |
13.16; 20.24 | < 0.001 sig |
| PRIMARY 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. |
.18; .92; 6.91; 7.15; .12; .21 | — |
| PRIMARY 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. |
308.61; 178.49; 5.82; 5.43; 52.50; 51.05 | — |
| SECONDARY 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. |
88.9; 70.3 | — |
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
Data sourced from ClinicalTrials.gov (NCT00841906). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.