Breathing-Related Sleep DisorderSTOP-BBACKNCT02446769
A Pilot Study to Assess the Effects of a Novel Application of Averaged Volume Assured Pressure Support Ventilation (AVAPS-AE) Therapy on Re-hospitalization in Patients With Sleep-Disordered Breathing With Co-morbid COPD
A study testing AVAPS-AE Non-invasive ventilation therapy in people with Breathing-Related Sleep Disorder, run by Philips Respironics at 1 site in United States.
Trial summary
This is a multicenter, randomized, parallel-group, open label study of the efficacy of AVAPS-AE to prevent re-hospitalization in hospitalized patients with comorbid Chronic Obstructive Pulmonary Disease (COPD). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Breathing-Related Sleep Disorder
- What is being tested?
- AVAPS-AE Non-invasive ventilation therapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Oct 2017to 21 May 2018
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Hospitalized patients who are at high risk for readmission who are at least 18 years of age.
- Specifically patients with (a) admission diagnosis of COPD AND (b) either a prior non-elective hospitalization (One in the past 12 months) OR active smoker who are ready for discharge AND (c) are also found to have sleep-disordered breathing (AHI ≥ 10 per hour; >3% oxygen desaturation for hypopneas) by overnight portable respiratory study prior to hospital discharge.
- Bedside spirometry revealing evidence for obstructive lung disease (post-bronchodilator; GOLD stage II or greater (FEV1 <70% predicted post BD).
- No previous home Positive Airway Pressure (PAP) or Non- Invasive Ventilation (NIV) use within the past year
Who cannot join
- Central sleep apnea (Central apnea index >5 per hour; and/or >50% are central apneas \& hypopneas)
- Clinically unstable, i.e., Acute Respiratory Failure, hypotensive shock, uncontrolled cardiac ischemia or arrhythmias, requiring life support ventilation or as otherwise determined by the investigator
- Participants with Stage III \& IV Chronic Heart Failure as defined by the New York Heart Association (NYHA) Classification
- Known or expected contraindications for the use of non-invasive ventilation per the assessment of the investigator.
- Lack of medical insurance
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Pilot, Multi-Center, Randomized, Open-Label, Parallel Group Study to Assess the Effects of a Novel Application of Averaged Volume Assured Pressure Support Ventilation (AVAPS-AE) Therapy on Re-hospitalization in Patients With Sleep-Disordered Breathing With Co-morbid COPD
This is a multicenter, randomized, parallel-group, open label study of the efficacy of AVAPS-AE to prevent re-hospitalization in hospitalized patients with comorbid Chronic Obstructive Pulmonary Disease (COPD).
Read the detailed description
This is a multicenter, randomized, parallel-group, open label study of the efficacy of AVAPS-AE to prevent re-hospitalization in hospitalized patients with comorbid COPD. Hospitalized patients with comorbid COPD who are at high risk for readmission will be recruited. Specifically patients with comorbid COPD who are to be discharged with (a) admission diagnosis of COPD (GOLD stage II or greater); AND (b) either a prior non-elective hospitalization (one in the past 12 months) OR active smoker. Such participants will undergo questionnaire-based screening for sleep-disordered breathing (STOP-BANG questionnaire) and if they have a high risk for Sleep Disordered Breathing (SDB) (> 3 points) will undergo an overnight portable sleep study for screening prior to hospital discharge (AHI > 10 per hour; >3% oxygen desaturation for hypopneas).
After randomization and prior to discharge, participants will either be initiated on AVAPS-AE therapy (intervention arm) for 60 days or will be referred to the sleep center for further diagnostic testing and therapy initiation (standard of care arm). Participants will complete quality of life questionnaires Functional outcomes of sleep questionnaire (FOSQ) at baseline (in-person), and in 30 and 60 days (by mail) post discharge. Information regarding hospital admission, diagnostic tests, medication changes, and procedures will be collected from all participants. Discharge summaries of re-hospitalizations and office or ER visits, as well as diagnostics tests and therapies received will be collected for measuring healthcare costs.
Participants will have an option to enroll in a registry for a 3 year follow-up and will also be queried on a yearly basis regarding hospitalizations, cardiovascular events, and assessment of vital statistics in the National Death Index registry. The study will conclude when all randomized participants have been followed for a minimum of 60 days.
- Conditions
- Breathing-Related Sleep Disorder
- Being tested
- AVAPS-AE Non-invasive ventilation therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AVAPS-AE Non-invasive ventilation therapyDevice
Participants will use the device greater than or equal to 4hrs per night for the 60 days after discharge.
| Study group | Role | What they receive |
|---|---|---|
| AVAPS-AE Non-invasive ventilation therapy | Experimental | Participants will be initiated on AVAPS-AE therapy (intervention arm) for 60 days. AVAPS-AE is a mode of therapy (Philips Respironics Inc, Monroeville, Pa) with potential advantages over the currently established modes of non-invasive positive pressure ventilation (CPAP and bilevel therapy). This mode of therapy incorporates AVAPS (automated adjustable Inspiratory Positive Airway Pressure (IPAP) setting to maintain target ventilation with a settable rate of change), Auto Expiratory Positive Airway Pressure (EPAP) and Auto Back up Rate. Receives: Device: AVAPS-AE Non-invasive ventilation therapy |
| Standard of Care Group | No intervention | Evaluation and treatment of the participant's sleep disordered breathing will be per their participant's health care provider's usual care pathway. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants Enrolled Requiring Emergent Healthcare (Such as Re-hospitalization, Unscheduled Physician Office Visits, Urgent Care Visits or Emergency Room Visits).
Evaluate the effects of novel application of Averaged Volume Assured Pressure Support (AVAPS-AE) therapy on the number of participants with emergent and non-emergent healthcare utilization with sleep-disordered breathing who are hospitalized with co-morbid Chronic Obstructive Pulmonary Disease (COPD), number of participants enrolled.
Measured: 60 days post-discharge
Composite End-point of Time (# of Days) to Occurrence of Emergent Healthcare Utilization (Such as Re-hospitalization, Unscheduled Physician Office Visits, Urgent Care Visits or Emergency Room Visits).
Evaluate the effects of novel application of Averaged Volume Assured Pressure Support (AVAPS-AE) therapy on time to (# of days) emergent and non-emergent healthcare utilization in patients with sleep-disordered breathing who are hospitalized with co-morbid Chronic Obstructive Pulmonary Disease (COPD).
Measured: 60 days post-discharge
Secondary outcomes (6)
Healthcare Costs
Evaluate the effects of novel application of Averaged Volume Assured Pressure Support (AVAPS-AE) therapy on the number of emergent and non-emergent healthcare utilization over 6 months; costs related to re-hospitalization; number of visits to physician offices or emergency rooms, and health-related quality of life (disease-specific and general HR-QOL measures).
Measured: 60 days post-discharge
Change in Quality of Life (SF-36) at 30 and 60 Days
Evaluate the effects of novel application of Averaged Volume Assured Pressure Support (AVAPS-AE) therapy on health-related quality of life. The Short Form 36 (SF-36) is a set of quality of life measures. Participants were asked at 30 days and 60 days in general what their overall health was. On a scale of 1 to 5 -1 being excellent, 5 being poor.
Measured: 30 and 60 days post-discharge
Change in Quality of Life (FOSQ) at 30 and 60 Days
FOSQ is a quality of life questionnaire for sleep disorders. It's a 30 question survey with 5 subgroups: general productivity (8 questions), social outcome (2 questions),activity level (9 questions), vigilance (7 questions) and intimate relationships \& sexual activity (4 questions).
Scores are provided on a 0 to 4 scale:
0- I don't do this activity for other reasons or missing response
1- Yes, extreme difficulty 4- no difficulty The average score was calculated based upon average sub-scores. The total score was, calculated using the mean of the subscale scores and multiplying the mean by the number of subscales. The range of scores for the total score is 5-20. The measures are designed to assess the impact of disorders of excessive sleepiness on activities of everyday living and the extent to which these abilities are improved by effective treatment. The lower the score the more difficulty a person has carrying out certain activities because they are too sleepy or tired.
Measured: 30 and 60 days post-discharge
Composite End-point of Time to Occurrence of Non-emergent Healthcare Utilization (Such as Scheduled Hospitalization, Scheduled Physician Office, Urgent Care Visits or Emergency Room Visits).
Evaluate the effects of novel application of Averaged Volume Assured Pressure Support (AVAPS-AE) therapy on the number of emergent and non-emergent healthcare utilization over 6 months; costs related to re-hospitalization; number of visits to physician offices or emergency rooms, and health-related quality of life (disease-specific and general HR-QOL measures).
Measured: 6 months
Time to Re-hospitalization Alone
Evaluate the effects of novel application of Averaged Volume Assured Pressure Support (AVAPS-AE) therapy on time to re-hospitalization alone.
Measured: 60 days post-discharge
Number of Hospitalizations Over 3 Years (Optional if Enrolled in Registry)
Evaluate the effects of novel application of Averaged Volume Assured Pressure Support (AVAPS-AE) therapy on the number of emergent and non-emergent healthcare utilization over 6 months; costs related to re-hospitalization; number of visits to physician offices or emergency rooms, and health-related quality of life (disease-specific and general HR-QOL measures).
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2015 (estimated)
- Study start6 Oct 2017
- Primary completion3 May 2018
- Study completion21 May 2018
Why it stopped: Difficulty recruiting patient population.
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 (4)Papers the sponsor has linked to this study.
- Other trials for Breathing-Related Sleep DisorderStudies 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
- None (open label)
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Philips Respironics
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- University of Arizona
- Responsible party
- Sponsor
- Investigators
- Sairam Parthasarathy, MD, Principal investigator, University of Arizona
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02446769
- Sponsor's protocol ID
- HRC-1426-BBACK-MS
- Acronym
- STOP-BBACK
- Status last verified
- Jul 2020
- First submitted
- 9 Apr 2015
- Last updated
- 5 Aug 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Publications
Briones Claudett KH, Briones Claudett M, Chung Sang Wong M, Nuques Martinez A, Soto Espinoza R, Montalvo M, Esquinas Rodriguez A, Gonzalez Diaz G, Grunauer Andrade M. Noninvasive mechanical ventilation with average volume assured pressure support (AVAPS) in patients with chronic obstructive pulmonary disease and hypercapnic encephalopathy. BMC Pulm Med. 2013 Mar 12;13:12. doi: 10.1186/1471-2466-13-12.
PubMed 23497021Marin JM, Soriano JB, Carrizo SJ, Boldova A, Celli BR. Outcomes in patients with chronic obstructive pulmonary disease and obstructive sleep apnea: the overlap syndrome. Am J Respir Crit Care Med. 2010 Aug 1;182(3):325-31. doi: 10.1164/rccm.200912-1869OC. Epub 2010 Apr 8.
PubMed 20378728Jencks SF, Williams MV, Coleman EA. Rehospitalizations among patients in the Medicare fee-for-service program. N Engl J Med. 2009 Apr 2;360(14):1418-28. doi: 10.1056/NEJMsa0803563.
PubMed 19339721Westert GP, Lagoe RJ, Keskimaki I, Leyland A, Murphy M. An international study of hospital readmissions and related utilization in Europe and the USA. Health Policy. 2002 Sep;61(3):269-78. doi: 10.1016/s0168-8510(01)00236-6.
PubMed 12098520
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot, Multi-Center, Randomized, Open-Label, Parallel Group Study to Assess the Effects of a Novel Application of Averaged Volume Assured Pressure Support Ventilation (AVAPS-AE) Therapy on Re-hospitalization in Patients With Sleep-Disordered Breathing With Co-morbid COPD
- ClinicalTrials.gov ID
- NCT02446769
- Acronym / sponsor ID
- STOP-BBACK / HRC-1426-BBACK-MS
- Conditions
- Breathing-Related Sleep Disorder
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Difficulty recruiting patient population.
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Philips RespironicsIndustry (pharma, biotech, devices)
- Collaborators
- University of Arizona
- Study start
- 6 Oct 2017 (actual)
- Primary completion
- 3 May 2018 (actual)
- Study completion
- 21 May 2018 (actual)
- First posted
- 18 May 2015 (estimated)
- Results
- Posted 10 Jul 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a multicenter, randomized, parallel-group, open label study of the efficacy of AVAPS-AE to prevent re-hospitalization in hospitalized patients with comorbid Chronic Obstructive Pulmonary Disease (COPD).
Detailed description
This is a multicenter, randomized, parallel-group, open label study of the efficacy of AVAPS-AE to prevent re-hospitalization in hospitalized patients with comorbid COPD. Hospitalized patients with comorbid COPD who are at high risk for readmission will be recruited. Specifically patients with comorbid COPD who are to be discharged with (a) admission diagnosis of COPD (GOLD stage II or greater); AND (b) either a prior non-elective hospitalization (one in the past 12 months) OR active smoker. Such participants will undergo questionnaire-based screening for sleep-disordered breathing (STOP-BANG questionnaire) and if they have a high risk for Sleep Disordered Breathing (SDB) (> 3 points) will undergo an overnight portable sleep study for screening prior to hospital discharge (AHI > 10 per hour; >3% oxygen desaturation for hypopneas).
After randomization and prior to discharge, participants will either be initiated on AVAPS-AE therapy (intervention arm) for 60 days or will be referred to the sleep center for further diagnostic testing and therapy initiation (standard of care arm). Participants will complete quality of life questionnaires Functional outcomes of sleep questionnaire (FOSQ) at baseline (in-person), and in 30 and 60 days (by mail) post discharge. Information regarding hospital admission, diagnostic tests, medication changes, and procedures will be collected from all participants. Discharge summaries of re-hospitalizations and office or ER visits, as well as diagnostics tests and therapies received will be collected for measuring healthcare costs.
Participants will have an option to enroll in a registry for a 3 year follow-up and will also be queried on a yearly basis regarding hospitalizations, cardiovascular events, and assessment of vital statistics in the National Death Index registry. The study will conclude when all randomized participants have been followed for a minimum of 60 days.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| AVAPS-AE Non-invasive ventilation therapy | Experimental | Device: AVAPS-AE Non-invasive ventilation therapyParticipants will be initiated on AVAPS-AE therapy (intervention arm) for 60 days. AVAPS-AE is a mode of therapy (Philips Respironics Inc, Monroeville, Pa) with potential advantages over the currently established modes of non-invasive positive pressure ventilation (CPAP and bilevel therapy). This mode of therapy incorporates AVAPS (automated adjustable Inspiratory Positive Airway Pressure (IPAP) setting to maintain target ventilation with a settable rate of change), Auto Expiratory Positive Airway Pressure (EPAP) and Auto Back up Rate. |
| Standard of Care Group | No intervention | –Evaluation and treatment of the participant's sleep disordered breathing will be per their participant's health care provider's usual care pathway. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Hospitalized patients who are at high risk for readmission who are at least 18 years of age.
- Specifically patients with (a) admission diagnosis of COPD AND (b) either a prior non-elective hospitalization (One in the past 12 months) OR active smoker who are ready for discharge AND (c) are also found to have sleep-disordered breathing (AHI ≥ 10 per hour; >3% oxygen desaturation for hypopneas) by overnight portable respiratory study prior to hospital discharge.
- Bedside spirometry revealing evidence for obstructive lung disease (post-bronchodilator; GOLD stage II or greater (FEV1 <70% predicted post BD).
- No previous home Positive Airway Pressure (PAP) or Non- Invasive Ventilation (NIV) use within the past year
Key exclusion criteria (5 listed)
- Central sleep apnea (Central apnea index >5 per hour; and/or >50% are central apneas \& hypopneas)
- Clinically unstable, i.e., Acute Respiratory Failure, hypotensive shock, uncontrolled cardiac ischemia or arrhythmias, requiring life support ventilation or as otherwise determined by the investigator
- Participants with Stage III \& IV Chronic Heart Failure as defined by the New York Heart Association (NYHA) Classification
- Known or expected contraindications for the use of non-invasive ventilation per the assessment of the investigator.
- Lack of medical insurance
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 Non-invasive ventilation therapyParticipants will use the device greater than or equal to 4hrs per night for the 60 days after discharge. | Device | AVAPS-AE Non-invasive ventilation therapy |
Primary outcome
Number of Participants Enrolled Requiring Emergent Healthcare (Such as Re-hospitalization, Unscheduled Physician Office Visits, Urgent Care Visits or Emergency Room Visits).
Time frame: 60 days post-discharge
Evaluate the effects of novel application of Averaged Volume Assured Pressure Support (AVAPS-AE) therapy on the number of participants with emergent and non-emergent healthcare utilization with sleep-disordered breathing who are hospitalized with co-morbid Chronic Obstructive Pulmonary Disease (COPD), number of participants enrolled.
Composite End-point of Time (# of Days) to Occurrence of Emergent Healthcare Utilization (Such as Re-hospitalization, Unscheduled Physician Office Visits, Urgent Care Visits or Emergency Room Visits).
Time frame: 60 days post-discharge
Evaluate the effects of novel application of Averaged Volume Assured Pressure Support (AVAPS-AE) therapy on time to (# of days) emergent and non-emergent healthcare utilization in patients with sleep-disordered breathing who are hospitalized with co-morbid Chronic Obstructive Pulmonary Disease (COPD).
6 secondary outcomes
Healthcare Costs
Time frame: 60 days post-discharge
Change in Quality of Life (SF-36) at 30 and 60 Days
Time frame: 30 and 60 days post-discharge
Change in Quality of Life (FOSQ) at 30 and 60 Days
Time frame: 30 and 60 days post-discharge
Composite End-point of Time to Occurrence of Non-emergent Healthcare Utilization (Such as Scheduled Hospitalization, Scheduled Physician Office, Urgent Care Visits or Emergency Room Visits).
Time frame: 6 months
Time to Re-hospitalization Alone
Time frame: 60 days post-discharge
Number of Hospitalizations Over 3 Years (Optional if Enrolled in Registry)
Time frame: 3 years
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Aug 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 23497021Briones Claudett KH, Briones Claudett M, Chung Sang Wong M, Nuques Martinez A, Soto Espinoza R, Montalvo M, Esquinas Rodriguez A, Gonzalez Diaz G, Grunauer Andrade M. Noninvasive mechanical ventilation with average volume assured pressure support (AVAPS) in patients with chronic obstructive pulmonary disease and hypercapnic encephalopathy. BMC Pulm Med. 2013 Mar 12;13:12. doi: 10.1186/1471-2466-13-12.
- Background: PubMed 20378728Marin JM, Soriano JB, Carrizo SJ, Boldova A, Celli BR. Outcomes in patients with chronic obstructive pulmonary disease and obstructive sleep apnea: the overlap syndrome. Am J Respir Crit Care Med. 2010 Aug 1;182(3):325-31. doi: 10.1164/rccm.200912-1869OC. Epub 2010 Apr 8.
- Background: PubMed 19339721Jencks SF, Williams MV, Coleman EA. Rehospitalizations among patients in the Medicare fee-for-service program. N Engl J Med. 2009 Apr 2;360(14):1418-28. doi: 10.1056/NEJMsa0803563.
- Background: PubMed 12098520Westert GP, Lagoe RJ, Keskimaki I, Leyland A, Murphy M. An international study of hospital readmissions and related utilization in Europe and the USA. Health Policy. 2002 Sep;61(3):269-78. doi: 10.1016/s0168-8510(01)00236-6.
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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
University of Arizona
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing AVAPS-AE Non-invasive ventilation therapy in people with Breathing-Related Sleep Disorder, run by Philips Respironics at 1 site 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 4 inclusion and 5 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: stopped early, as of the sponsor's last update on 5 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 10 Jul 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?
Number of Participants Enrolled Requiring Emergent Healthcare (Such as Re-hospitalization, Unscheduled Physician Office Visits, Urgent Care Visits or Emergency Room Visits). (time frame: 60 days post-discharge). The study lists 2 primary outcomes in all. 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 NCT02446769, which also lists 4 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 5 Aug 2020.