N/A
Completed N=20
Comparison of Auto-Adjusting Positive Airway Pressure Devices
Source: ClinicalTrials.gov NCT02357706 ↗Enrolled (actual)
20
Serious AEs
0.0%
Results posted
Apr 2020
Primary outcomePrimary: Mean Apnoea-Hypopnoea-Index (AHI) — 6.21; 7.45 events/hour — p=0.537
Summary
Little is understood about how different auto-adjusting PAP devices operate. The purpose of this evaluation is to compare two devices in a randomised two night PSG trial.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mean Apnoea-Hypopnoea-Index (AHI) |
6.21; 7.45 | 0.537 |
| PRIMARY Mean Oxygen Desaturation Index (ODI) |
7.94; 10.63 | 0.205 |
| SECONDARY Obstructive Apnoea Index (OAI) |
0.580; 0.885 | — |
| SECONDARY Central Apnoea Index (CAI) |
2.36; 2.51 | — |
| SECONDARY Mixed Apnoea Index (MAI) |
0.115; 0.220 | — |
| SECONDARY Hypopnoea-Index HI |
3.17; 5.49 | — |
| SECONDARY Respiratory Effort Related Arousals RERAs |
0.0; 2.81 | — |
| SECONDARY Flow Limitation (%) |
49.25; 43.16 | — |
| SECONDARY Mean O2 Saturation |
94.210; 93.680 | — |
Eligibility Criteria
Inclusion Criteria
- Males aged ≥ 18 years
- Recently diagnosed with OSA (AHI ≥15). Recently defined as less than 3 months before study entry
- Naive to CPAP therapy
- Participants willing and able to give written informed consent
Exclusion Criteria
- Participants requiring Bi-level PAP
- Participants requiring supplemental oxygen
- Participants who are pregnant
- Subjects who have a pre existing lung disease/ condition that would predispose them to pneumothorax (for example: COPD, lung cancer; fibrosis of the lungs; recent (< 2years) case of pneumonia or lung infection; lung injury)
Data sourced from ClinicalTrials.gov (NCT02357706). 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.