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AVAPS-AE Efficacy Study

Primary Purpose

Obesity Hypoventilation Syndrome

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
AVAPS-AE Mode of Therapy
Respironics OnmiLab BiPAP S mode
Respironics OmniLab Advanced CPAP mode
Sponsored by
Philips Respironics
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Obesity Hypoventilation Syndrome focused on measuring OHS

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • University of Arizona School of Medicine
  • University of Chicago

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Active Comparator

Arm Label

AVAPS-AE

Respironics OmniLab Advanced BiPAP S mode

Respironics OmniLab Advanced CPAP mode

Arm Description

AVAPS-AE Mode of ventilation

OmniLab Advanced BiPAP S Mode of ventilation

OmniLab Advanced CPAP Mode of ventilation

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
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.
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.
Ventilator Adherence - Average Hours
The average number of hours ventilator was used per each day used.
Ventilator Adherence - Days Used
Average number of days used per week
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.
Room Air Sp02 Assessment Via Pulse Oximetry
Oxygen saturation measurements as determined by pulse oximetry
Nocturnal Transcutaneous Capnography (TcC02)
Nocturnal Transcutaneous Capnography is a non-invasive monitoring tool to measure ventilation over the night. .
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.
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.
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.
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)
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.
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.

Full Information

First Posted
May 23, 2011
Last Updated
April 25, 2019
Sponsor
Philips Respironics
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1. Study Identification

Unique Protocol Identification Number
NCT01368614
Brief Title
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

2. Study Status

Record Verification Date
April 2019
Overall Recruitment Status
Completed
Study Start Date
September 12, 2011 (Actual)
Primary Completion Date
May 30, 2013 (Actual)
Study Completion Date
May 30, 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Philips Respironics

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity Hypoventilation Syndrome
Keywords
OHS

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
90 (Actual)

8. Arms, Groups, and Interventions

Arm Title
AVAPS-AE
Arm Type
Experimental
Arm Description
AVAPS-AE Mode of ventilation
Arm Title
Respironics OmniLab Advanced BiPAP S mode
Arm Type
Active Comparator
Arm Description
OmniLab Advanced BiPAP S Mode of ventilation
Arm Title
Respironics OmniLab Advanced CPAP mode
Arm Type
Active Comparator
Arm Description
OmniLab Advanced CPAP Mode of ventilation
Intervention Type
Device
Intervention Name(s)
AVAPS-AE Mode of Therapy
Intervention Description
AVAPS-AE mode is the experimental mode of therapy in this study that includes a combination of already cleared therapy attributes.
Intervention Type
Device
Intervention Name(s)
Respironics OnmiLab BiPAP S mode
Intervention Description
Currently cleared Non-Invasive Ventilation (NIV) therapy modality
Intervention Type
Device
Intervention Name(s)
Respironics OmniLab Advanced CPAP mode
Intervention Description
Currently cleared NIV therapy modality
Primary Outcome Measure Information:
Title
Daytime Partial Pressure of Carbon Dioxide in Arterial Blood (PaCO2)
Description
Daytime PaCO2 measurements will be assessed for all randomized patients to each mode of ventilation therapy (AVAPS-AE, bilevel PSV, CPAP) after 6 weeks.
Time Frame
Screening & 6 weeks
Secondary Outcome Measure Information:
Title
Daytime Partial Pressure of Oxygen in Arterial Blood(Pa02)
Description
Daytime Pa02 measurements will be assessed for all randomized patients to each mode of ventilation therapy (AVAPS-AE, bilevel PSV, CPAP) after 6 weeks.
Time Frame
Screening & 6 weeks
Title
Apnea Hypopnea Index (AHI)
Description
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.
Time Frame
Screening & 6 weeks
Title
Epworth Sleepiness Scale
Description
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.
Time Frame
Screening & 6 weeks
Title
Severe Respiratory Insufficiency Questionnaire (SRIQ)
Description
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.
Time Frame
Screening & 6 weeks
Title
Ventilator Adherence - Average Hours
Description
The average number of hours ventilator was used per each day used.
Time Frame
6 weeks
Title
Ventilator Adherence - Days Used
Description
Average number of days used per week
Time Frame
6 weeks
Title
Actigraphy
Description
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.
Time Frame
Screening & 6 weeks
Title
Room Air Sp02 Assessment Via Pulse Oximetry
Description
Oxygen saturation measurements as determined by pulse oximetry
Time Frame
Screening & 6 weeks
Title
Nocturnal Transcutaneous Capnography (TcC02)
Description
Nocturnal Transcutaneous Capnography is a non-invasive monitoring tool to measure ventilation over the night. .
Time Frame
Screening & 6 weeks
Title
Duration, Efficiency and Quality of Sleep and Sleepiness (Derived From Sleep Study) - Duration
Description
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.
Time Frame
Screening & 6 weeks
Title
Duration and Quality of Sleep and Sleepiness (Derived From Sleep Study) - Sleep Efficiency
Description
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.
Time Frame
Screening & 6 weeks
Title
Duration, Efficiency and Quality of Sleep and Sleepiness (Derived From Sleep Study)- Arousal and Awakening Indices
Description
The arousal index is measured by the average number of arousals or awakenings a participant has over an hour of sleep.
Time Frame
Screening & 6 weeks
Title
Duration, Efficiency and Quality of Sleep and Sleepiness (Derived From Sleep Study)- Nocturnal O2 Saturation
Description
Measurement of overnight oxygen saturation as measured by percentage of oxygen saturation (SpO2)
Time Frame
Screening & 6 weeks
Title
Reaction Time (Psychomotor Vigilance Test-PVT)
Description
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.
Time Frame
Screening & 6 weeks
Title
Number of Participants With Need for Continued Oxygen Supplementation
Description
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.
Time Frame
Screening & 6 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sairam Parthasarathy, MD
Organizational Affiliation
Southern Arizona VA Healthcare
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Babak Mokhlesi, MD
Organizational Affiliation
University of Chicago
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Arizona School of Medicine
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85723
Country
United States
Facility Name
University of Chicago
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
32713421
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.
Results Reference
derived
PubMed Identifier
29734990
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.
Results Reference
derived

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AVAPS-AE Efficacy Study

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