Radiofrequency Volumetric Tissue Reduction of the Palate in Subjects With Sleep-Disordered Breathing: Criteria of Exclusion

4 May

Radiofrequency Volumetric Tissue Reduction of the Palate in Subjects With Sleep-Disordered Breathing: Criteria of ExclusionUpper Airway Resistance Syndrome: This was an RDI of less than five events per hour of sleep with an Sa02 of >90% during total sleep time and an inspiratory nadir Pes more negative than —10 cm H20 with an accompanied complaint of daytime sleepiness.
Mild OSAS: This was an RDI of 5 to 15 events per hour of sleep with a maximum Sa02 drop to 85% (nadir) during total nocturnal sleep time.
Criteria of Exclusion
Excluded from this investigation were subjects in the anesthetic groups of American Society of Anesthesiologists class III to V and those with morbid obesity (body mass index [BMI] 32 kg/m2). Those subjects with radiographic findings of marked skeletal mandibular micrognathia, defined as a sella nasion point B angle (SNB) of <74°, and/or fiberoptic evidence of moderate or severe tongue base narrowing, were also excluded. The criteria were established to minimize the potential danger to an already “at risk” population, where application of experimental treatment to the upper airway might create an edematous effect. Patients with a history of previous palatal surgery and those with speech or swallowing problems were excluded. Subjects with a history or finding of a coagulopathy, a neurologic or psychiatric disorder, or those with implanted pacemakers were also excluded.

Polysomnography was performed in the sleep laboratory prior to treatment with full monitoring that included an EEG, electrooculogram, chin and leg electromyograms, ECG (modified V2 lead), airflow, thoracic and abdominal efforts, pulse oximetry, Pes measurements. Subjects reserved the right to refuse Pes measurement, as indicated in the informed consent and requested by the IRB. A second polysomnogram was performed with monitoring of the same variables on all subjects at 48 to 72 h after the first RFe application. One of the primary objectives of this study was to assess the sleep and respiratory variables secondary to any edematous changes. Edema is expected at 24 to 72 h after soft-tissue insult and has been reported after traditional palate surgery and laser treatment. The polysomnographic variables were to be examined for trends and used to help confirm or establish limits of RF energy delivery that could be used safely on an outpatient basis. A minimum of 8 weeks after completion of the final RF treatment to the soft palate, a third and final polysomnogram was done on all subjects and compared with the pretreatment records.