Obesity Hypoventilation SyndromeNCT01368614
AVAPS-AE Efficacy Study
A study testing AVAPS-AE Mode of Therapy, Respironics OnmiLab BiPAP S mode and Respironics OmniLab Advanced CPAP mode in people with Obesity Hypoventilation Syndrome, run by Philips Respironics at 2 sites in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Obesity Hypoventilation Syndrome
- What is being tested?
- AVAPS-AE Mode of Therapy, Respironics OnmiLab BiPAP S mode and Respironics OmniLab Advanced CPAP mode
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 2 sitesUnited States
- Study dates
- 12 Sep 2011to 30 May 2013
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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%
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
University of Chicago
Chicago, Illinois, 60637
University of Arizona School of Medicine
Tucson, Arizona, 85723
About this study
Official title: 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.
- Conditions
- Obesity Hypoventilation Syndrome
- Being tested
- AVAPS-AE Mode of Therapy, Respironics OnmiLab BiPAP S mode, Respironics OmniLab Advanced CPAP mode
- Keywords
- OHS
- Medical subject headings
- Obesity Hypoventilation Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AVAPS-AE Mode of TherapyDevice
AVAPS-AE mode is the experimental mode of therapy in this study that includes a combination of already cleared therapy attributes.
Respironics OnmiLab BiPAP S modeDevice
Currently cleared Non-Invasive Ventilation (NIV) therapy modality
Respironics OmniLab Advanced CPAP modeDevice
Currently cleared NIV therapy modality
| Study group | Role | What they receive |
|---|---|---|
| AVAPS-AE | Experimental | AVAPS-AE Mode of ventilation Receives: Device: AVAPS-AE Mode of Therapy |
| Respironics OmniLab Advanced BiPAP S mode | Active comparator | OmniLab Advanced BiPAP S Mode of ventilation Receives: Device: Respironics OnmiLab BiPAP S mode |
| Respironics OmniLab Advanced CPAP mode | Active comparator | OmniLab Advanced CPAP Mode of ventilation Receives: Device: Respironics OmniLab Advanced CPAP mode |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Screening & 6 weeks
Secondary outcomes (15)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Screening & 6 weeks
Ventilator Adherence - Average Hours
The average number of hours ventilator was used per each day used.
Measured: 6 weeks
Ventilator Adherence - Days Used
Average number of days used per week
Measured: 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.
Measured: Screening & 6 weeks
Room Air Sp02 Assessment Via Pulse Oximetry
Oxygen saturation measurements as determined by pulse oximetry
Measured: Screening & 6 weeks
Nocturnal Transcutaneous Capnography (TcC02)
Nocturnal Transcutaneous Capnography is a non-invasive monitoring tool to measure ventilation over the night.
.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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)
Measured: 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.
Measured: 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.
Measured: Screening & 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2011 (estimated)
- Study start12 Sep 2011
- Primary completion30 May 2013
- Study completion30 May 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Obesity Hypoventilation SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Philips Respironics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Sairam Parthasarathy, MD, Principal investigator, Southern Arizona VA HealthcareBabak Mokhlesi, MD, Principal investigator, University of Chicago
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01368614
- Sponsor's protocol ID
- HRC-1006-AVAPS-AE-MS
- Status last verified
- Apr 2019
- First submitted
- 23 May 2011
- Last updated
- 26 Apr 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
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.
PubMed 32713421Bhattacharjee 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.
PubMed 29734990
Study at a glance
From the registry record, last updated by the sponsor on 26 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Trial Evaluating the Feasibility of AVAPS-AE vs. CPAP vs.Bilevel Pressure Support Ventilation in Obesity Hypoventilation Syndrome
- ClinicalTrials.gov ID
- NCT01368614
- Acronym / sponsor ID
- HRC-1006-AVAPS-AE-MS
- Conditions
- Obesity Hypoventilation Syndrome
- Keywords
- OHS
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Philips RespironicsIndustry (pharma, biotech, devices)
- Study start
- 12 Sep 2011 (actual)
- Primary completion
- 30 May 2013 (actual)
- Study completion
- 30 May 2013 (actual)
- First posted
- 8 Jun 2011 (estimated)
- Results
- Posted 26 Apr 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| AVAPS-AE | Experimental | Device: AVAPS-AE Mode of TherapyAVAPS-AE Mode of ventilation |
| Respironics OmniLab Advanced BiPAP S mode | Active comparator | Device: Respironics OnmiLab BiPAP S modeOmniLab Advanced BiPAP S Mode of ventilation |
| Respironics OmniLab Advanced CPAP mode | Active comparator | Device: Respironics OmniLab Advanced CPAP modeOmniLab Advanced CPAP Mode of ventilation |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
- Daytime pH > 7.35
- Forced Expiratory Volume at 1 second / forced vital capacity (FEV1/FVC) > 70%
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AVAPS-AE Mode of TherapyAVAPS-AE mode is the experimental mode of therapy in this study that includes a combination of already cleared therapy attributes. | Device | AVAPS-AE |
| Respironics OnmiLab BiPAP S modeCurrently cleared Non-Invasive Ventilation (NIV) therapy modality | Device | Respironics OmniLab Advanced BiPAP S mode |
| Respironics OmniLab Advanced CPAP modeCurrently cleared NIV therapy modality | Device | Respironics OmniLab Advanced CPAP mode |
Primary outcome
Daytime Partial Pressure of Carbon Dioxide in Arterial Blood (PaCO2)
Time frame: Screening & 6 weeks
Daytime PaCO2 measurements will be assessed for all randomized patients to each mode of ventilation therapy (AVAPS-AE, bilevel PSV, CPAP) after 6 weeks.
15 secondary outcomes
Daytime Partial Pressure of Oxygen in Arterial Blood(Pa02)
Time frame: Screening & 6 weeks
Apnea Hypopnea Index (AHI)
Time frame: Screening & 6 weeks
Epworth Sleepiness Scale
Time frame: Screening & 6 weeks
Severe Respiratory Insufficiency Questionnaire (SRIQ)
Time frame: Screening & 6 weeks
Ventilator Adherence - Average Hours
Time frame: 6 weeks
Ventilator Adherence - Days Used
Time frame: 6 weeks
Actigraphy
Time frame: Screening & 6 weeks
Room Air Sp02 Assessment Via Pulse Oximetry
Time frame: Screening & 6 weeks
Nocturnal Transcutaneous Capnography (TcC02)
Time frame: Screening & 6 weeks
Duration, Efficiency and Quality of Sleep and Sleepiness (Derived From Sleep Study) - Duration
Time frame: Screening & 6 weeks
Duration and Quality of Sleep and Sleepiness (Derived From Sleep Study) - Sleep Efficiency
Time frame: Screening & 6 weeks
Duration, Efficiency and Quality of Sleep and Sleepiness (Derived From Sleep Study)- Arousal and Awakening Indices
Time frame: Screening & 6 weeks
Duration, Efficiency and Quality of Sleep and Sleepiness (Derived From Sleep Study)- Nocturnal O2 Saturation
Time frame: Screening & 6 weeks
Reaction Time (Psychomotor Vigilance Test-PVT)
Time frame: Screening & 6 weeks
Number of Participants With Need for Continued Oxygen Supplementation
Time frame: Screening & 6 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Apr 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 32713421Lastra 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.
- Derived from this study: PubMed 29734990Bhattacharjee 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sairam Parthasarathy, MD principal investigator
Southern Arizona VA Healthcare
Babak Mokhlesi, MD principal investigator
University of Chicago
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing AVAPS-AE Mode of Therapy, Respironics OnmiLab BiPAP S mode and Respironics OmniLab Advanced CPAP mode in people with Obesity Hypoventilation Syndrome, run by Philips Respironics at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 26 Apr 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Daytime Partial Pressure of Carbon Dioxide in Arterial Blood (PaCO2) (time frame: Screening & 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01368614, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Apr 2019.