N/A
Completed N=44
Evaluation of the Philips Respironics BiPAP autoSV Devices in Subjects With Sleep Disorders
sleep-disordered breathing · Sleep Apnea, Central
Source: ClinicalTrials.gov NCT01626989 ↗
Enrolled (actual)
44
Serious AEs
1.0%
Results posted
Apr 2019
Primary outcomePrimary: Apnea-Hypopnea Index (AHI) — 38; 13; 12 events per hour — p=.001
Summary
Comparing two BiPAP autoSV devices in participants with complex sleep apnea and determining if the new device will treat those participants no worse than when compared to its predecessor device.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Apnea-Hypopnea Index (AHI) |
38; 13; 12 | .001 sig |
| SECONDARY Non Rapid Eye Movement (NREM) and Rapid Eye Movement (REM) Percentage Based on Total Sleep Time (TST) Indices |
22; 18; 17; 61; 65; 65 | — |
| SECONDARY Central Apnea Index(CAI) |
12; 1; 1 | — |
| SECONDARY Obstructive Apnea Index (OAI) |
14; 1; 2 | — |
| SECONDARY Mixed Apnea Index (MAI) |
4; 0.3; 0.6 | — |
| SECONDARY Sleep Onset Latency (SOL) |
16.6; 19.3; 24.3 | — |
| SECONDARY REM Onset Latency (ROL) |
— | — |
| SECONDARY Wake After Sleep Onset (WASO) |
59.1; 64.1; 54.2 | — |
| SECONDARY Total Sleep Time (TST) |
354.0; 352.4; 368.1 | — |
| SECONDARY Sleep Efficiency (SE %) |
82; 81; 82 | — |
| SECONDARY Wake (W), Stages N1,N2,N3 (NREM), and REM (R) Sleep |
— | — |
| SECONDARY Arousal Index |
22; 16; 16 | — |
| SECONDARY Nocturnal Oxygenation |
82; 86; 84 | — |
| SECONDARY Hypopnea Index (HI) |
9; 11; 8 | — |
Eligibility Criteria
Inclusion Criteria
- Age 21-80
- Ability to provide consent
- Documentation of medical stability by investigator
- Subjects who currently have been on Positive Airway Pressure (PAP) therapy for ≥ 4 weeks and who previously had a Continuous Positive Airway Pressure (CPAP) titration with CAI ≥ 5.
OR Subjects who currently have been on PAP therapy for ≥ 4 weeks and who had a diagnostic study done, with a CAI ≥ 5, and were prescribed PAP therapy without a CPAP titration.
- Agreement to undergo a full-night, in-lab research CPAP Titration
- Agreement to undergo two full-night, in-lab therapy research Polysomnography (PSG) on BiPAP autoSV devices
Exclusion Criteria
- Major medical or psychiatric condition that would interfere with the demands of the study, adherence to positive airway pressure, or the ability to complete the study. For example, unstable congestive heart failure, chronic lung disease, neuromuscular disease, daytime hypercapnia, cancer, or renal failure.
- Systolic blood pressure 15).
Data sourced from ClinicalTrials.gov (NCT01626989). 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.