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

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 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.

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 PAP or 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