Since to our knowledge diis technology had not been used previously in the tissues of the upper airway, die investigation was limited to nonobese, healthy patients with snoring, upper airway resistance syndrome (UARS), or mild OS AS. This selection criteria was to minimize the potential adverse effects or risks of this procedure that might include excessive pain, bleeding, infection, tissue slough, obstruction secondaiy to airway edema, problems with speech and swallowing, as well as the possibility that the subject’s condition might actually worsen. diabetes amaryl
Materials and Methods
Volunteers enrolled in this investigation were 18 to 65 years of age. All were seeking treatment for symptomatic chronic (habitual) snoring and reported symptoms of daytime sleepiness. Each subject was counseled regarding the alternative treatment options. Although a reduction in snoring was the main objective motivating each subject to enroll, each was advised that attenuation of snoring was a secondaiy objective in this experimental investigation. The primary and secondary objectives outlined previously were carefully presented to all subjects, and they were asked to sign an informed consent approved by the IRB. Each subject underwent a complete history and physical examination. This included a detailed evaluation of the upper airway anatomy using cephalometric radiographs along with fiberoptic nasopha-ryngoscopy that was intended to evaluate the level of obstruction. The remaining inclusion and exclusion criteria for the subjects were determined as follows:
Criteria of Inclusion
Subjects were required to have the following subjective complaints related to breathing during sleep: chronic (habitual) disruptive snoring, present for >1 year, leading to social and family disruption, as well as reported fatigue and/or sleepiness during the daytime that interfered with social or professional activities. The upper airway of each potential subject was examined, and only those in whom the major site of obstruction was located at the palate were accepted. A negative p-human chorionic gonadotropin test was required of each of the women prior to each treatment session. All subjects were required to meet the criteria for classification as anesthetic risk 1 or 2 (American Society of Anesthesiologists class). Each subject was required to meet predetermined polysomnographic eligibility criteria and needed to fall into one of the three groups below.
Chronic Snoring: Chronic snoring was a respiratoiy disturbance index (RDI) of less than five events per hour of sleep with no oxygen saturation (Sa02) <90% during sleep and a peak negative end-inspiratory esophageal pressure or inspiratory nadir (Pes) of less negative than —10 cm H20. Chronic snoring was defined, in this study, as habitual loud and disruptive upper airway noise during sleep that was noted by the patient and complained about by the bed partner for >1 year. To qualify as chronic snoring, the frequency needed to be a nightly occurrence.