AVAPS-AE Efficacy Study

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-09-12

Study Completion Date

2013-05-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Obesity Hypoventilation Syndrome

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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AVAPS-AE

AVAPS-AE Mode of ventilation

Group Type EXPERIMENTAL

AVAPS-AE Mode of Therapy

Intervention Type DEVICE

AVAPS-AE mode is the experimental mode of therapy in this study that includes a combination of already cleared therapy attributes.

Respironics OmniLab Advanced BiPAP S mode

OmniLab Advanced BiPAP S Mode of ventilation

Group Type ACTIVE_COMPARATOR

Respironics OnmiLab BiPAP S mode

Intervention Type DEVICE

Currently cleared Non-Invasive Ventilation (NIV) therapy modality

Respironics OmniLab Advanced CPAP mode

OmniLab Advanced CPAP Mode of ventilation

Group Type ACTIVE_COMPARATOR

Respironics OmniLab Advanced CPAP mode

Intervention Type DEVICE

Currently cleared NIV therapy modality

Interventions

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AVAPS-AE Mode of Therapy

AVAPS-AE mode is the experimental mode of therapy in this study that includes a combination of already cleared therapy attributes.

Intervention Type DEVICE

Respironics OnmiLab BiPAP S mode

Currently cleared Non-Invasive Ventilation (NIV) therapy modality

Intervention Type DEVICE

Respironics OmniLab Advanced CPAP mode

Currently cleared NIV therapy modality

Intervention Type DEVICE

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No