A Trial to Evaluate a Device for the Treatment of OSA and Snoring (OPEN)

Inclusion Criteria:

• • Aged 18-65

  • AHI greater than or equal to 10 but less than or equal to 60 (<10 AHI <60/hr)
  • Complete set of lower anterior incisors with no evidence of periodontal disease or mobility and the ability to floss between teeth

Additionally subjects will in the screening phase must:

• Tolerate the device when being fitted
• Used the device for >4 hours on at least two consecutive nights during the screening period.
• Be able to reliably demonstrate proper installation of the device after fitting.
• Be willing to trial the device for a 4 week period

Exclusion Criteria:

• • Central sleep apnea events >10% of the total events

  • Evidence of Cheyne stokes breathing
  • Currently on treatment for OSA or OSA treatment discontinued less than 3 months prior.
  • Currently on regular treatment with prescription hypnosedatives or prescription stimulants
  • Very severe OSA, defined as AHI>60/hour and/or minimum oxygen saturation <75%
  • Need for immediate initiation of treatment as assessed by physician (e.g. Excessive sleepiness posing driving risk)
  • Previous surgery to treat OSA (other than nasal surgery)
  • Evidence of periodontal disease or tooth mobility
  • Severe nasal obstruction or enlarged tonsils based on clinical assessment
  • Unstable cardiovascular disease (untreated hypertension acceptable).
  • Inability to tolerate oral device due to oral condition or claustrophobia as determined by the study investigator
  • Pregnant/Breast Feeding
  • Any known factor or disease that might interfere with treatment compliance, study conduct or interpretation of the results such as co-existent other sleep disorder, psychiatric disease, history of non compliance to medical regimens, or unwillingness to comply with study requirements.