This investigation evaluates the effects of radiofrequency energy (RFe) to the palate in human subjects with mild sleep-disordered breathing (SDB). In the past, the RFe ablation of soft tissues has been applied successfully to humans by specialists in the fields of neurology, cardiology, oncology, and urology. We have previously reported on the application of this technology to an in vivo porcine animal tongue model. In the porcine study, the relationship of lesion size to total RFe delivery and subsequent tissue volume reduction was established. The healing process was analyzed histologically and demonstrated favorable wound healing. However, in the porcine model, the character of pain and the effects on speech and swallowing after RFe was used could not be assessed.
The primary study objectives for this investigation were designed to answer these questions as well as others. These included the effect and extent of the edematous response, as well as evaluations of tissue shrinkage and safety (energy limits and adverse effects). In addition, it was necessary to examine the applied biophysics of the essential parameters of RFe to ensure a safe delivery of treatment and optimal shrinkage to the delicate tissues of the palate. The secondary objectives of the study were to evaluate the positive or negative impact of the technology on sleep and snoring, although from the subject’s perspective, this was the primary goal and reason for participation. The soft palate (retropalatal level) was selected for this study since anatomically it is readily visible and assessable. This region of the upper airway is more compliant in subjects with SDB than in normal individuals, as well as narrower, and it is commonly treated surgically for snoring and obstructive sleep apnea syndrome (OSAS). canadian family pharmacy online
This is a prospective nonrandomized radiofrequency (RF) study in a group of subjects with mild SDB and snoring. The investigation was previously approved by the institutional review board (IRB). All treatments were performed on an outpatient basis using only a local anesthetic. To minimize the chance of delivering unnecessarily high levels of RFe to the soft tissues of the palate, a series of conservative low-to mid-level energy treatments was planned. This approach also allowed adequate follow-up time for outcomes data to be collected and assessed. Resolution or attenuation of snoring was used to help determine the end point of treatment for each patient.