This region was then divided into upper, middle, and lower thirds and right and left paramedian positions. This arbitrary division was used to facilitate record keeping since multiple treatments were administered, and we wished to avoid retreating the same area unintentionally (Fig 1). A 30-gauge needle was used to inject 2.0 mL of 0.5% bupivaeaine hydrochloride (Mar-caine) along the treatment site. A 22-gauge RF needle electrode (10-mm active length with a 10-mm protective sheath) in a custom-fabricated device allowed placement of the electrode under the palatal mucosa in the area selected for treatment. RFe was then delivered for 60 to 170 s. The patients were allowed to leave within 3 to 5 min after completion of treatment. The total treatment time, which included the record keeping for the investigative protocol, required approximately 15 to 20 min. It is emphasized that an IV route was neither needed nor used. To limit the effects of confounding variables such as systemic drugs, sedative premedication was not given, and antibiotics and corticosteroids were not used preoperatively or postoperatively.
Each subject was scheduled for follow-up on the first day posttreatment and then at day 2 or 3. Each was also evaluated at 1, and then again at 3 or 4 weeks. This follow-up mandated at least four visits for each treatment session. At each visit, an interview and clinical examination were performed, and questionnaires and VAS scales were completed. After the 3- to 4-week follow-up, patient outcome variables were re-evaluated and, if necessary, the subject was offered an additional treatment based on these results. With each subsequent treatment, evaluations were completed as described above. Once the subject and his or her respective bed partner registered a VAS snoring score of 0 to 3 cm (“no snoring noise” to “nonbothersome” snoring), the subject was scheduled to undergo the final evaluation. This comprehensive evaluation was scheduled a minimum of 8 weeks and a maximum of 12 weeks after the final treatment. It included the clinical interview and examination, cephalometrics, questionnaires, scales, and polysomnography. Sufficient data collection was achieved on all subjects to assess the primary objectives.
Figure 1. Midline palate thirds. The muscular anatomy of the soft palate as viewed without the mucosa. Treatments were confined to the midportion of the palate along the course of the uvular muscle since this region is the thickest portion of the palate. Arbitrary divisions into midline thirds, right and left paramedian were done to assist in keeping track of individual treatment sites.