N/A
Completed N=44
Evaluation of Software Enhancements to the Respironics BiPAP Auto Servo Ventilation (AutoSV) Device
sleep-disordered breathing · Sleep Apnea, Central
Source: ClinicalTrials.gov NCT00720213 ↗
Enrolled (actual)
44
Serious AEs
0.0%
Results posted
Jan 2019
Primary outcomePrimary: Apnea Hypopnea Index — 10.44; 6.06 events/hour — p=0.0054
Summary
This study is being undertaken to collect data from Respironics Inc's BiPAP Auto Servo Ventilation 3 (autoSV3) and compare with data from Respironics, Inc's BiPAP autoSV2, to confirm that the algorithms in the BiPAP autoSV3 device can safely and effectively treat participants experiencing Complex Sleep Apneas (Comp SAS) no worse than its predecessor, the BiPAP auto Servo ventilation 2 (autoSV2) device. This will be determined using a comparative, randomized design with the participants blinded to the therapy. Additionally, attempts will be made to blind the central scorer(s) with respect to which device is in use.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Apnea Hypopnea Index |
10.44; 6.06 | 0.0054 sig |
| SECONDARY Apnea Hypopnea Index- REM and NREM |
3.27; 2.09; 6.84; 11.74 | — |
| SECONDARY Central Apnea Index |
2.82; 0.56 | — |
| SECONDARY Obstructive Apnea Index |
2.04; 1.14 | — |
| SECONDARY Mixed Apnea Index |
0.44; 0.20 | — |
| SECONDARY Hypopnea Index |
5.11; 4.16 | — |
| SECONDARY Sleep Onset Latency |
18.91; 20.91 | — |
| SECONDARY Rapid Eye Movement (REM) Onset Latency |
— | — |
| SECONDARY Wake After Sleep Onset |
88.67; 93.47 | — |
| SECONDARY Total Sleep Time |
361.23; 370.59 | — |
| SECONDARY Sleep Efficiency |
76.84; 76.46 | — |
| SECONDARY Stages N1,N2,N3 (NREM), and REM (R) Sleep (in Minutes)REM, NREM and Total Sleep Time. |
16.72; 16.02; 54.54; 55.06; 13.25; 11.75 | — |
| SECONDARY Wake (W), Stages N1,N2,N3 (NREM), and REM (R) Sleep (% TST) |
16.72; 16.02; 54.54; 55.06; 13.25; 11.75 | — |
| SECONDARY Arousal Index [Total, Apnea Hypopnea (AH)-Related, Periodic Limb Movement (PLM)-Related, 'Spontaneous'] |
26.04; 23.58 | — |
| SECONDARY Nocturnal Oxygenation (Measured by Continuous Pulse Oximetry During Sleep Study) |
95.78; 95.7; 86.54; 87.84 | — |
| SECONDARY Apnea Hypopnea Index (REM, NREM and TST) Using Modified Hypopnea Rule. |
— | — |
| SECONDARY Apnea Hypopnea Index(REM, NREM and TST) During Epochs for Which Leak is Determined to Exist Within Acceptable Limits. |
— | — |
Eligibility Criteria
Inclusion Criteria
Pre-Study Inclusion Criteria:
- Age 21-80
- Ability to provide consent
- Documentation of medical stability by investigator
Enrollment Inclusion Criteria:
- Participants who, during the ambulatory polysomnography (PSG) study (Stardust), or in lab Diagnostic PSG demonstrated an Apnea Hypopnea Index (AHI) ≥10 or Central Apnea Index (CAI) ≥5
or
- Participants who previously demonstrated Central sleep Apnea (CSA), with a CAI≥5 on Continuous Positive Airway Pressure (CPAP) titration.
Exclusion Criteria
- • Participants who are acutely ill, medically complicated or who are medically unstable.
- Pregnancy (will confirm absence of pregnancy with a urine or serum pregnancy test in women of child bearing potential).
- Participants in whom PAP therapy is otherwise medically contraindicated.
- Participants who are unwilling to wear CPAP
- Participants who are currently prescribed nocturnal oxygen use and are unable to forego oxygen during study nights.
- Participants with previously diagnosed respiratory failure or respiratory insufficiency and who are known to have chronically elevated arterial carbon dioxide levels while awake (PaCO2 ≥ 45mmHg).
- Participants who have had surgery of the upper airway, nose, sinus, or middle ear within the previous 90 days.
- Participants with untreated, non- Obstructive Sleep Apnea (OSA)/CSA sleep disorders, including but not limited to; insomnia, periodic limb movement syndrome, or restless legs syndrome (PLM Arousal Index > 15).
- Participants who are unwilling to participate in the study.
Data sourced from ClinicalTrials.gov (NCT00720213). 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.