Paid Volunteers Needed for Participation in Research Sleep Study

What is the Vivo NOVA study?
The goal of the Vivo NOVA study is to evaluate the safety and effectiveness of the auto-EPAP feature on the Vivo 45LS Ventilator. The Vivo 45LS ventilator can help keep the airways open during sleep while providing respiratory support to patients diagnosed with e.g. obesity hypoventilation syndrome (OHS), chronic obstructive pulmonary disease (COPD), or neuromuscular disease (DMD, ALS).
The research team will observe and document data from the sleep lab to determine if the auto-EPAP feature performs similarly to manual- EPAP in preventing a drop
in blood oxygen levels during an overnight PSG assessment.
Approximately 20 participants may be enrolled in this study.

What will happen during the study?
• Participation in this study will last approximately 5 weeks.
• If you decide to take part in this research study, the general procedures include collecting information about your medical history and medications, and review of data from your currently used ventilator or Bi PAP device.
• Once eligibility is confirmed, you will participate in two separate overnight stays at
a sleep lab where a polysomnography (PSG sleep study) will be performed. During the PSG you will be using the Vivo 45LS fitted with your own face mask, if possible.
• Participants will receive compensation and are eligible for travel reimbursement.

Are you Eligible?
• 18 years or older
• Diagnosis of chronic respiratory insufficiency or failure due to:
• Chronic Obstructive Pulmonary Disease (COPD)
• Obesity Hypoventilation Syndrome (OHS)
• Neuromuscular Disease (NMD)
• With Co-Existing Obstructive Sleep Apnea
• Qualifying diagnostic PSG resulting in AHi at least 5 per hour (untreated)
• Currently using non-invasive ventilation (NIV) during sleep for the at least 3 months
• EPAP settings have been reviewed in the last 12 months
• Can tolerate at least 4 hours of NIV use

Locations:
Colorado Springs, CO
Columbia, SC
Scottsdale, AZ

Study sponsored by Breas.