N/A
Completed N=90
AVAPS-AE Efficacy Study
Source: ClinicalTrials.gov NCT01368614 ↗Enrolled (actual)
90
Serious AEs
6.3%
Results posted
Apr 2019
Primary outcomePrimary: Daytime Partial Pressure of Carbon Dioxide in Arterial Blood (PaCO2) — 47.1; 51.8; 50.7; 40.7 mmHg
Summary
The purpose of this study is to evaluate the feasibility of using of the Average Volume Assured Pressure Support (AVAPS-AE) mode versus Continuous Positive Airway Pressure (CPAP) and bilevel pressure support ventilation (PSV) modes of ventilation in patients diagnosed with Obesity Hypoventilation syndrome (OHS).
The investigators believe the use of the AVAPS-AE mode of ventilation after 6 weeks will yield daytime gas exchange values which are equivalent or no worse when compared to using CPAP and bilevel PSV modes of ventilation in the OHS population.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Daytime Partial Pressure of Carbon Dioxide in Arterial Blood (PaCO2) |
47.1; 51.8; 50.7; 40.7; 47.4; 40.8 | — |
| SECONDARY Daytime Partial Pressure of Oxygen in Arterial Blood(Pa02) |
62.8; 56.9; 62.6; 65.0; 58.7; 66.2 | — |
| SECONDARY Apnea Hypopnea Index (AHI) |
84.5; 67.7; 85.4; 16.1; 22.4; 30.1 | — |
| SECONDARY Epworth Sleepiness Scale |
14.9; 12.0; 11.5; 9.8; 8.1; 5.9 | — |
| SECONDARY Severe Respiratory Insufficiency Questionnaire (SRIQ) |
52.0; 53.4; 60.0; 61.0; 64.8; 69.7 | — |
| SECONDARY Ventilator Adherence - Average Hours |
4.8; 5.2; 6.6 | — |
| SECONDARY Ventilator Adherence - Days Used |
5.3; 5.3; 6.9 | — |
| SECONDARY Actigraphy |
— | — |
| SECONDARY Room Air Sp02 Assessment Via Pulse Oximetry |
92.5; 90.6; 92.9; 94.6; 90.1; 94.1 | — |
| SECONDARY Nocturnal Transcutaneous Capnography (TcC02) |
— | — |
| SECONDARY Duration, Efficiency and Quality of Sleep and Sleepiness (Derived From Sleep Study) - Duration |
28.4; 24.6; 18.9; 10.0; 13.1; 10.1 | — |
| SECONDARY Duration and Quality of Sleep and Sleepiness (Derived From Sleep Study) - Sleep Efficiency |
74.4; 64.5; 74.6; 86.8; 71.4; 74.4 | — |
| SECONDARY Duration, Efficiency and Quality of Sleep and Sleepiness (Derived From Sleep Study)- Arousal and Awakening Indices |
68.2; 66.0; 71.4; 19.4; 23.0; 21.3 | — |
| SECONDARY Duration, Efficiency and Quality of Sleep and Sleepiness (Derived From Sleep Study)- Nocturnal O2 Saturation |
84.2; 81.6; 81.1; 92.7; 93.3; 94.5 | — |
| SECONDARY Reaction Time (Psychomotor Vigilance Test-PVT) |
3987.13; 4752.75; 4523.25; 2978.89; 5681.83; 6705.20 | — |
| SECONDARY Number of Participants With Need for Continued Oxygen Supplementation |
1; 4; 0; 0; 2; 1 | — |
Eligibility Criteria
Inclusion Criteria
- Age greater than or equal to 18 years of age; less than or equal to 70 years of age
- Diagnosis of Obesity Hypoventilation Syndrome via a diagnostic sleep study in the past 3 months but have not initiated therapy
- BMI greater than or equal to 30 kg/m2
- Daytime PaCO2 greater than or equal to 45 mmHg
- Apnea Hypopnea index (AHI) > 5
- Daytime pH > 7.35
- Forced Expiratory Volume at 1 second / forced vital capacity (FEV1/FVC) > 70%
Exclusion Criteria
- Acutely ill, medically complicated or who are medically stable, or as otherwise determined by the investigator
- Respiratory alkalosis (pH > 7.45), per investigator discretion
- Emergency admissions on chronic respiratory failure
- Hospitalization for respiratory exacerbation < 6 weeks prior to screening visit
- Participants in whom PAP therapy is otherwise medically contraindicated
- Impaired upper airway function. For example, obstruction due to infections(laryngitis, epiglottis), craniofacial malformations, tumors, uvulopalatopharyngoplasty, presence of tracheostomy, or bilateral vocal cord palsy that does not allow tolerance of Non-invasive positive pressure ventilation (NPPV)
- Facial trauma, burns, surgery or anatomical abnormalities interfering with mask fit.
Data sourced from ClinicalTrials.gov (NCT01368614). 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.