Radiofrequency Volumetric Tissue Reduction of the Palate in Subjects With Sleep-Disordered Breathing: Treatment Summary Results

14 May

The diagnosis of snoring or mild SDB using the predetermined inclusion criteria was OSAS in 31.8% of subjects (7/22) and UARS in 63.6% of subjects (14/22). No subject was classified as having UARS without a Pes measurement. Three subjects refused Pes on baseline polysomnography. Two of these had an RDI of greater than five events per hour of sleep and fit the criteria for OSAS. The third subject refused Pes measurements on each study. This subject was either a chronic snorer or had UARS, since he reported daytime sleepiness and had an RDI of <5. Clinical variables pretreatment and posttreatment are presented in Table 1. Results indicate that BMI, systolic BP, and diastolic BP did not change significantly.

Treatment Summary Results
Twenty-two patients underwent a total of 80 office visits for RFe treatment. The mean number of office visits per patient for RFe treatment was 3.6±1.2. Each patient, during his or her respective office visit, received a minimum of one or a maximum of three separate RFe ablations, and each such ablation was done at a different site in the palate. At the end of the study, a total of 117 separate ablations (RFe) had been applied to the total study group (n=22), with a total mean of 5±2 sites. At treatment visit 1, all 22 patients (100%) received RF treatments. This consisted of 46 separate applications; 8 subjects had applications at one site only, 4 at two sites, and 10 at three sites. At treatment visit 2, 21 of 22 patients (95%) underwent 29 separate applications, with 15 subjects having treatment at one site, only 4 at two sites, and 2 at three sites. Similarly, at visit 3, 19 of 22 patients (86%) received 24 separate applications with 15 at one site, 3 at two sites, and 1 at three sites. Thereafter, in visits 4, 5, and 6, 12 patients, 5 patients, and 1 patient, respectively, received a single application. Eighty-nine of the 117 treatments were to the midline thirds, and 15 included a combination of midline with right and/or left paramedian location. The overall investigation for an individual patient, from the first treatment (RF treatments) to 8 to 12 weeks after the last treatment, extended 22 ±5.8 weeks.
Table 1—Baseline to Posttreatment

VariableBaseline ValuePost-Tx ValueChangep Value
Clinical measures
BMI27.1±3.227.4±3.40.25 ±1.20.343
Systolic BP126± 11.3125±12.3-0.63±11.20.792
Diastolic BP80.2±11.982.3±10.02.05 ±14.10.505
Cephalometric measures
SNA angle, 80.8+4.1Measured only at baseline
SNB angle, °78.4±3.8Measured only at baseline
PNS-P, mm46.5±3.841.0 ±3.6—5.5±3.7<0.0001
PW, mm10.5±2.310.7 ±1.90.18±1.50.576
PAS, mm9.4±3.6Measured only at baseline
MP-H, mm18.2±5.5Measured only at baseline