Clinical trial NCT01368614: AVAPS-AE Efficacy Study
Official title: Randomized Controlled Trial Evaluating the Feasibility of AVAPS-AE vs. CPAP vs.Bilevel Pressure Support Ventilation in Obesity Hypoventilation Syndrome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity Hypoventilation Syndrome
Keywords: OHS
Lead sponsor: Philips Respironics
Sponsor class: INDUSTRY
First posted: 2011-06-08
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Daytime Partial Pressure of Carbon Dioxide in Arterial Blood (PaCO2)
timeFrame: Screening & 6 weeks
Secondary outcomes:
measure: Daytime Partial Pressure of Oxygen in Arterial Blood(Pa02)
timeFrame: Screening & 6 weeks
measure: Apnea Hypopnea Index (AHI)
timeFrame: Screening & 6 weeks
measure: Epworth Sleepiness Scale
timeFrame: Screening & 6 weeks
measure: Severe Respiratory Insufficiency Questionnaire (SRIQ)
timeFrame: Screening & 6 weeks
measure: Ventilator Adherence - Average Hours
timeFrame: 6 weeks
measure: Ventilator Adherence - Days Used
timeFrame: 6 weeks
measure: Actigraphy
timeFrame: Screening & 6 weeks
measure: Room Air Sp02 Assessment Via Pulse Oximetry
timeFrame: Screening & 6 weeks
measure: Nocturnal Transcutaneous Capnography (TcC02)
timeFrame: Screening & 6 weeks
measure: Duration, Efficiency and Quality of Sleep and Sleepiness (Derived From Sleep Study) - Duration
timeFrame: Screening & 6 weeks
measure: Duration and Quality of Sleep and Sleepiness (Derived From Sleep Study) - Sleep Efficiency
timeFrame: Screening & 6 weeks
measure: Duration, Efficiency and Quality of Sleep and Sleepiness (Derived From Sleep Study)- Arousal and Awakening Indices
timeFrame: Screening & 6 weeks
measure: Duration, Efficiency and Quality of Sleep and Sleepiness (Derived From Sleep Study)- Nocturnal O2 Saturation
timeFrame: Screening & 6 weeks
measure: Reaction Time (Psychomotor Vigilance Test-PVT)
timeFrame: Screening & 6 weeks
measure: Number of Participants With Need for Continued Oxygen Supplementation
timeFrame: Screening & 6 weeks
Other outcomes:
Locations:
city: Tucson
country: United States
facility: University of Arizona School of Medicine
state: Arizona
city: Chicago
country: United States
facility: University of Chicago
state: Illinois
Study officials:
affiliation: Southern Arizona VA Healthcare
name: Sairam Parthasarathy, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Chicago
name: Babak Mokhlesi, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.