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 (STOP-BBACK)

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).

Study Overview

• Status: Terminated
• Conditions: Breathing-Related Sleep Disorder
• Intervention / Treatment: Device: AVAPS-AE Non-invasive ventilation therapy

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 Type: Interventional
• Enrollment (Actual): 18
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Tucson, Arizona, United States, 85724
      • University of Arizona

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Hospitalized patients who are at high risk for readmission who are at least 18 years of age.
2. 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.
3. Bedside spirometry revealing evidence for obstructive lung disease (post-bronchodilator; GOLD stage II or greater (FEV1 <70% predicted post BD).
4. No previous home Positive Airway Pressure (PAP) or Non- Invasive Ventilation (NIV) use within the past year

Exclusion Criteria:

1. Central sleep apnea (Central apnea index >5 per hour; and/or >50% are central apneas & hypopneas)
2. 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
3. Participants with Stage III & IV Chronic Heart Failure as defined by the New York Heart Association (NYHA) Classification
4. Known or expected contraindications for the use of non-invasive ventilation per the assessment of the investigator.
5. Lack of medical insurance

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: AVAPS-AE Non-invasive ventilation therapy; 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.	Device: AVAPS-AE Non-invasive ventilation therapy; Participants will use the device greater than or equal to 4hrs per night for the 60 days after discharge.
No Intervention: Standard of Care Group; 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 the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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).	60 days post-discharge

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	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.	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.	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).	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.	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).	3 years

Collaborators and Investigators

• Sponsor: Philips Respironics
• Collaborators: University of Arizona

Publications and helpful links

General Publications

• Marin 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.
• Jencks 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. Erratum In: N Engl J Med. 2011 Apr 21;364(16):1582.
• 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.
• Westert 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.

Study record dates

Study Major Dates

• Study Start (Actual): October 6, 2017
• Primary Completion (Actual): May 3, 2018
• Study Completion (Actual): May 21, 2018

Study Registration Dates

• First Submitted: April 9, 2015
• First Submitted That Met QC Criteria: May 13, 2015
• First Posted (Estimate): May 18, 2015

Study Record Updates

• Last Update Posted (Actual): August 5, 2020
• Last Update Submitted That Met QC Criteria: July 22, 2020
• Last Verified: July 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Pathologic Processes; Nervous System Diseases; Respiratory Tract Diseases; Apnea; Respiration Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Neurologic Manifestations; Sleep Apnea Syndromes; Sleep Wake Disorders; Respiratory Aspiration
• Other Study ID Numbers: HRC-1426-BBACK-MS

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes