AVAPS-AE Efficacy Study

NCT01368614 | Completed Results

• 1 other identifier: HRC-1006-AVAPS-AE-MS
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Obesity Hypoventilation Syndrome

Keywords

OHS

Outcome Measures

Primary Outcomes (1)

• Daytime Partial Pressure of Carbon Dioxide in Arterial Blood (PaCO2)

  Daytime PaCO2 measurements will be assessed for all randomized patients to each mode of ventilation therapy (AVAPS-AE, bilevel PSV, CPAP) after 6 weeks.

  Screening & 6 weeks

Secondary Outcomes (15)

• Daytime Partial Pressure of Oxygen in Arterial Blood(Pa02)

  Screening & 6 weeks

• Apnea Hypopnea Index (AHI)

  Screening & 6 weeks

• Epworth Sleepiness Scale

  Screening & 6 weeks

• Severe Respiratory Insufficiency Questionnaire (SRIQ)

  Screening & 6 weeks

• Ventilator Adherence - Average Hours

  6 weeks

Study Arms (3)

AVAPS-AE

EXPERIMENTAL

AVAPS-AE Mode of ventilation

Device: AVAPS-AE Mode of Therapy

Respironics OmniLab Advanced BiPAP S mode

ACTIVE COMPARATOR

OmniLab Advanced BiPAP S Mode of ventilation

Device: Respironics OnmiLab BiPAP S mode

Respironics OmniLab Advanced CPAP mode

ACTIVE COMPARATOR

OmniLab Advanced CPAP Mode of ventilation

Device: Respironics OmniLab Advanced CPAP mode

Interventions

AVAPS-AE Mode of Therapy DEVICE

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

AVAPS-AE

Respironics OnmiLab BiPAP S mode DEVICE

Currently cleared Non-Invasive Ventilation (NIV) therapy modality

Respironics OmniLab Advanced BiPAP S mode

Respironics OmniLab Advanced CPAP mode DEVICE

Currently cleared NIV therapy modality

Respironics OmniLab Advanced CPAP mode

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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%

You may not qualify if:

• 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.

Sponsors & Collaborators

• Philips Respironics: lead

Study Sites (2)

University of Arizona School of Medicine

Tucson, Arizona, 85723, United States

Location

University of Chicago

Chicago, Illinois, 60637, United States

Location

Related Publications (2)

• Lastra AC, Masa JF, Mokhlesi B. CPAP titration failure is not equivalent to long-term CPAP treatment failure in patients with obesity hypoventilation syndrome: a case series. J Clin Sleep Med. 2020 Nov 15;16(11):1975-1981. doi: 10.5664/jcsm.8712.

  PMID: 32713421 DERIVED

• Bhattacharjee R, Khalyfa A, Khalyfa AA, Mokhlesi B, Kheirandish-Gozal L, Almendros I, Peris E, Malhotra A, Gozal D. Exosomal Cargo Properties, Endothelial Function and Treatment of Obesity Hypoventilation Syndrome: A Proof of Concept Study. J Clin Sleep Med. 2018 May 15;14(5):797-807. doi: 10.5664/jcsm.7110.

  PMID: 29734990 DERIVED

MeSH Terms

Conditions

Obesity Hypoventilation Syndrome

Condition Hierarchy (Ancestors)

Sleep Apnea, Obstructive; Sleep Apnea Syndromes; Apnea; Respiration Disorders; Respiratory Tract Diseases; Hypoventilation; Respiratory Insufficiency; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Obesity; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases

Results Point of Contact

• Title: Jeff Jasko
• Organization: Philips

jeff.jasko@philips.com

412-542-3651

Study Officials

• Sairam Parthasarathy, MD

  Southern Arizona VA Healthcare

  PRINCIPAL INVESTIGATOR

• Babak Mokhlesi, MD

  University of Chicago

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 23, 2011
• First Posted: June 8, 2011
• Study Start: September 12, 2011
• Primary Completion: May 30, 2013
• Study Completion: May 30, 2013
• Last Updated: April 26, 2019
• Results First Posted: April 26, 2019

Record last verified: 2019-04

Locations

US (2)