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The ClearDream® is intended to reduce night time snoring and mild to moderate obstructive sleep apnea (OSA) in adults.

The ClearDream® is an intraoral device and is intended to reduce night time snoring and mild to moderate obstructive sleep apnea (OSA) in adults. The product is a prescription-only, customized device for use by a single patient; dentist titratable mandibular repositioning device worn during sleep to reduce night time snoring and mild to moderate obstructive sleep apnea (OSA) in adults. Dental impressions must be used to construct the device. A bite registration reflecting the relationship between the patient's mandible (lower jaw) and maxilla (upper jaw) is taken at the dental office. The product consists of 2 pieces. Both pieces are constructed using polymethyl methacrylate acrylic (PMMA). One piece fits over the maxillary (upper jaw) dental arch and is retained by the maxillary teeth. The maxillary piece has blocks of acrylic located bilaterally on the buccal surfaces. One expansion stainless steel screw is encased in each one of the acrylic blocks. The mandibular (lower jaw) piece is fitted over the mandibular arch and is retained by the lower dental arch. The mandibular piece features bilateral buccally located flanges that engage the upper mechanisms. This engagement repositions the mandible protrusively to decrease air turbulence, increase pharyngeal space, and maintain airway patency. It also permits the patient to open their mouth allowing patient comfort. The ClearDream® appliance keeps the PMMA covering the lingual surfaces of the lower teeth to a minimum. The duration of the interval of wearing the device is 8 hours or less. The PMMA material used is identical to the predicate device, and therefore does not present any possible biocompatibility differences that have been tested on the PMMA. The ClearDream® is accompanied by an adjustment key used by the dentist. The dentist uses the adjustment key to move the bilateral, buccally-located expansion stainless steel screws allowing forward mandibular advancement a maximum from baseline of 6.5 millimeters, thereby improving patency of the airway, decreasing air turbulence, and reducing obstructive apnea occurrences.