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) 

Advanced ENT Physicians & Surgeons

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