Dr. Edward T. Sall at Advanced ENT Physicians and Surgeons of CNY is looking for volunteers with severe Obstructive Sleep Apnea (OSA) to participate in a clinical research study
The purpose of the study is to evaluate the safety and effectiveness of the ProSomnus® EVO™ Sleep and Snore Device in individuals with severe Obstructive Sleep Apnea (OSA).
If you choose to participate, you would be asked to attend multiple study visits over a 12- to 14-month period and complete several two-night sleep studies in your home. In appreciation for your time, you would be provided with a custom ProSomnus EVO Sleep and Snore Device at no charge.
To be eligible for this study, you must meet the following criteria:
- Aged 18-80 years
- Diagnosed with uncomplicated severe OSA
- Body mass index < 45 kg/m2
- Neck circumference < 50 cm
- Absence of severe oxyhemoglobin desaturation during sleep, indicated by mean nocturnal SpO2 > 87% (low oxygen level in blood)
- Mandibular (jaw) range of motion > 5 mm in protrusive direction
- Adequate dentition, as determined by the study dentist
You would not be eligible for the study if you meet any of the following criteria:
- Inability to breathe through the nose comfortably
- Presence of > 25% central sleep apnea
- Presence of positional Obstructive Sleep Apnea
- History of surgery intended to alter anatomy for the correction of Obstructive Sleep Apnea
- Presence of hypoglossal (tongue) nerve stimulation device
- Use of CPAP or use of Oral Appliance Therapy within the two weeks prior to the screening home sleep test
- History of Oral Appliance Therapy that has been demonstrated to provide effective therapy within the two years prior to the screening home sleep test
- Anticipated change in medical therapy during the study protocol that could alter the severity of your Obstructive Sleep Apnea
- Loose teeth or advanced periodontal (gum) disease
- History of temporomandibular (jaw) joint disorder
- Resistant hypertension (high blood pressure)
- Presence of congestive heart failure, recurrent atrial fibrillation (irregular heart beat), or coronary artery disease
- Presence of neuromuscular diseases, hypoventilation (shallow breathing) disorders, or cerebrovascular (brain blood vessel) disease
- Presence of pulmonary (lung) disease resulting in significant desaturation
- History of cerebrovascular incident within the last 12 months
- Use of pacemaker or other life supporting device
- Anticipated change in body weight > 5% during the study period
- Participation in other studies that could interfere with the study protocol
- Pregnancy or lactation (breast feeding)
- In the opinion of the investigator, unsuitable for inclusion in the study

This study has been approved by WCG IRB (protocol # 20223306; approval # 34582316.0)
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