AVAPS-AE Efficacy Study

Randomized Controlled Trial Evaluating the Feasibility of AVAPS-AE vs. CPAP vs.Bilevel Pressure Support Ventilation in Obesity Hypoventilation Syndrome

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.

Study Overview

• Status: Completed
• Conditions: Obesity Hypoventilation Syndrome
• Intervention / Treatment: Device: AVAPS-AE Mode of Therapy; Device: Respironics OnmiLab BiPAP S mode; Device: Respironics OmniLab Advanced CPAP mode

• Study Type: Interventional
• Enrollment (Actual): 90
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Tucson, Arizona, United States, 85723
      • University of Arizona School of Medicine
  • Illinois
    • Chicago, Illinois, United States, 60637
      • University of Chicago

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: AVAPS-AE; AVAPS-AE Mode of ventilation	Device: 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.
Active Comparator: Respironics OmniLab Advanced BiPAP S mode; OmniLab Advanced BiPAP S Mode of ventilation	Device: Respironics OnmiLab BiPAP S mode; Currently cleared Non-Invasive Ventilation (NIV) therapy modality
Active Comparator: Respironics OmniLab Advanced CPAP mode; OmniLab Advanced CPAP Mode of ventilation	Device: Respironics OmniLab Advanced CPAP mode; Currently cleared NIV therapy modality

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Daytime Partial Pressure of Oxygen in Arterial Blood(Pa02)	Daytime Pa02 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
Apnea Hypopnea Index (AHI)	The AHI is the number of apneas and hypopneas per hour of sleep. It will be evaluated during the screening sleep study and the 6 week follow up sleep study. AHI less than 5 is considered normal. For an Apnea-Hypopnea Index (or AHI) from 5 to 15 denotes mild sleep apnea. Fifteen to 30 is moderate, while a greater than 30 AHI is considered severe.	Screening & 6 weeks
Epworth Sleepiness Scale	Epworth Sleepiness scale is a measure of daytime sleepiness. It is a series of 8 questions answered on a scale of 0 to 3, 0 being no chance of dozing and 3 being a high chance of dozing. The range of the scale is 0 to 24. The higher the total score, the higher the chance of falling asleep.	Screening & 6 weeks
Severe Respiratory Insufficiency Questionnaire (SRIQ)	The SRIQ is a 49 question survey. This survey asks questions about the past week. It is answered on a scale of -2 to 2 and converted to 1 to 5, 1 is completely untrue and 5 is always true. The questionnaire is broken down into 7 sections when scoring: respiratory complaints, physical functioning, attendant systems and sleep, social relationships, anxiety, psychological well-being and social functioning. Once each scale score is calculated. The average score can be calculated by taking the mean of the subscales. This process of transformation produces a score between 0 and 100 with higher values indicating a better health-related quality of life according to content of the scale.	Screening & 6 weeks
Ventilator Adherence - Average Hours	The average number of hours ventilator was used per each day used.	6 weeks
Ventilator Adherence - Days Used	Average number of days used per week	6 weeks
Actigraphy	Actigraphy is a method of measuring activity and sleep which is achieved by wearing a small watch-like device for an extended period of time. The data is intended to provide an objective measure of physical activity and sleep / week patterns during pre / post sleep studies and throughout the 6 weeks of home use.	Screening & 6 weeks
Room Air Sp02 Assessment Via Pulse Oximetry	Oxygen saturation measurements as determined by pulse oximetry	Screening & 6 weeks
Nocturnal Transcutaneous Capnography (TcC02)	Nocturnal Transcutaneous Capnography is a non-invasive monitoring tool to measure ventilation over the night. .	Screening & 6 weeks
Duration, Efficiency and Quality of Sleep and Sleepiness (Derived From Sleep Study) - Duration	Duration, efficiency and quality of sleepiness are measured by a number of different parameters. Total sleep time in each stage provides the average amount of time a participant was in that stage of sleep. This includes Stage 1, Stage 2, Stage 3/4, and Rapid Eye Movement (REM) sleep.	Screening & 6 weeks
Duration and Quality of Sleep and Sleepiness (Derived From Sleep Study) - Sleep Efficiency	Duration, efficiency and quality of sleepiness are measured by a number of different parameters. Sleep efficiency is measured by the total time a participant is spent asleep.	Screening & 6 weeks
Duration, Efficiency and Quality of Sleep and Sleepiness (Derived From Sleep Study)- Arousal and Awakening Indices	The arousal index is measured by the average number of arousals or awakenings a participant has over an hour of sleep.	Screening & 6 weeks
Duration, Efficiency and Quality of Sleep and Sleepiness (Derived From Sleep Study)- Nocturnal O2 Saturation	Measurement of overnight oxygen saturation as measured by percentage of oxygen saturation (SpO2)	Screening & 6 weeks
Reaction Time (Psychomotor Vigilance Test-PVT)	To measure trends of vigilance between the baseline screening assessment and the 6 week follow up visit comparing the three Arms/Groups. This measured how quickly participants reacted to visual stimulus. Reaction time is the latency at which the participant reacts to a visual stimulus > 100 ms.	Screening & 6 weeks
Number of Participants With Need for Continued Oxygen Supplementation	Some users enrolled into the study required supplemental oxygen at different times during the day: at rest, during exertion and at night. The need for supplemental oxygen was compared at baseline and at 6 weeks.	Screening & 6 weeks

Collaborators and Investigators

• Sponsor: Philips Respironics
• Investigators: Principal Investigator: Sairam Parthasarathy, MD, Southern Arizona VA Healthcare; Principal Investigator: Babak Mokhlesi, MD, University of Chicago

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): September 12, 2011
• Primary Completion (Actual): May 30, 2013
• Study Completion (Actual): May 30, 2013

Study Registration Dates

• First Submitted: May 23, 2011
• First Submitted That Met QC Criteria: June 7, 2011
• First Posted (Estimate): June 8, 2011

Study Record Updates

• Last Update Posted (Actual): April 26, 2019
• Last Update Submitted That Met QC Criteria: April 25, 2019
• Last Verified: April 1, 2019

More Information

Terms related to this study

• Keywords: OHS
• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Respiratory Tract Diseases; Apnea; Respiration Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Disease; Overnutrition; Nutrition Disorders; Overweight; Body Weight; Signs and Symptoms, Respiratory; Sleep Apnea Syndromes; Respiratory Insufficiency; Sleep Apnea, Obstructive; Syndrome; Obesity; Hypoventilation; Obesity Hypoventilation Syndrome
• Other Study ID Numbers: HRC-1006-AVAPS-AE-MS