Sample Cases

Exhibit C: Patient Case Summaries

A total of five (5) patient case summaries are required. For each patient case summary, the pre-treatment PSG must be formally interpreted by a board-certified sleep physician, whose diagnosis must reflect an AHI >10 and be clearly documented. The post-treatment PSG must also be interpreted by a board-certified physician. A post-treatment home sleep study is acceptable if it is read and scored by a board-certified sleep physician.

Two (2) patient case studies of unsuccessful or non-responders, either surgical or non-surgical, may be included in the five (5) required patient case summaries. Patient case summaries involving non-responders must be accompanied by detailed written explanations of possible reasons for non-responses to treatment.

Exhibits D-1 through D-5: Expanded Patient Cases

Five (5) expanded patient case studies are required. Pre-treatment and post-treatment PSGs for each case 1) may be administered at an accredited sleep laboratory or as a home sleep test, 2) must be read and scored by a board-certified sleep physician, and 3) must document successful cases in patients with pre-treatment AHI >10 and post-treatment AHI reduced by one-half plus relief of subjective symptoms.

Documentation of pre-treatment PSG and diagnosis by a board-certified sleep physician must be included whether the PSG is administered at an accredited sleep laboratory or as a home sleep study. Post-treatment PSG must also be read and scored by a board-certified sleep physician, and may also be completed at an accredited sleep laboratory or as a home sleep study.