Evaluation of a novel device for measuring patient compliance with oral appliances in the treatment of obstructive sleep apnea.

PURPOSE: The purpose of this study was to evaluate a novel intraoral monitor for measuring patient compliance of oral appliances for the treatment of obstructive sleep apnea. MATERIALS AND METHODS: A clinical trial was conducted to compare objective recording by an intraoral compliance monitor and self-reporting by participants using a mandibular repositioning device (MRD). Ten participants were fitted with a Thornton Adjustable Positioner (TAP III) with an embedded compliance monitor. The participants were asked to wear the test appliance for seven nights and to record their usage of the appliance and any adverse effects in a treatment journal. The data were downloaded to a dedicated computer using radio-frequency identification (RFID) technology, and the information was compared to the data in the participant's journal. RESULTS: The mean objective wearing time, as detected by the compliance monitor, was found to be 6.6 ± 1.6 hours/night. The mean subjective wearing time, as recorded by the participants, was 6.5 ± 1.5 hours/night. The correlation between subjective and objective times was 0.9985. The use of the test appliance by this sample population was 68.7% with a range of 24% to 100%. Participants reported a range of adverse outcomes related to the MRD consistent with those reported in the literature and were found to be transient in nature. CONCLUSIONS: This study supports previously reported usage times and adverse outcomes. The compliance monitor showed a very high linear correlation between subjective and objective data, validating its use in future compliance studies.