Objective measurement of compliance during oral appliance therapy for sleep-disordered breathing

Olivier M Vanderveken, Marijke Dieltjens, Kristien Wouters, Wilfried A De Backer, Paul H Van de Heyning, Marc J Braem, Olivier M Vanderveken, Marijke Dieltjens, Kristien Wouters, Wilfried A De Backer, Paul H Van de Heyning, Marc J Braem

Abstract

Background: Oral appliance (OA) therapy is increasingly prescribed as a non-continuous positive airway pressure treatment modality for sleep-disordered breathing (SDB). Although OA therapy is reported to be efficacious for the treatment of SDB, data on compliance remain limited to self-report.

Methods: In this 3-month prospective clinical trial, the main outcome was to assess the safety and feasibility of an objective measurement of compliance during OA therapy using an embedded microsensor thermometer with on-chip integrated readout electronics in 51 consecutive patients with an established diagnosis of SDB (AHI 18.0 ± 11.9/h; age 47 ± 10 y; BMI 26.6 ± 4.0 kg/m(2); men/women: 31/20). Patients were unaware of the purpose of the study.

Results: No microsensor-related adverse events were recorded. In addition, no problems were encountered during the readout of the compliance data. Out of 51 microsensors, one had a technical defect and was lost to follow-up. In this study, the overall objective mean rate of OA use was 6.6 ± 1.3 h per day with a regular OA users' rate of 82% at the 3-month follow-up. Statistical analysis revealed no significant differences between objective and self-reported OA compliance data in this study. Measurement of the objective OA compliance allowed us to calculate the mean disease alleviation (MDA) as the product of objective compliance and therapeutic efficacy. MDA serves as a measure of the overall therapeutic effectiveness, and turned out to be 51.1%.

Conclusions: The results illustrate the safety and feasibility of objective measurement of OA compliance. The objective measurement of OA compliance allows for calculation of the MDA.

Figures

Figure 1
Figure 1
The microsensor thermometer with on-chip integrated readout electronics used in this study (TheraMon, IFT Handels- und Entwicklungsgesellschaft GmbH, Handelsagentur Gschladt, Hargelsberg, Austria) has a weight of 0.40±0.01 g, a length of 13.0±0.1 mm, a width of 9.0±0.1 mm and a height of 4.3±0.1 mm. The sampling interval of the temperature recording was programmed at one measurement per 15 min with a memory capacity of approximately 100 consecutive days.
Figure 2
Figure 2
The microsensor is sealed into the upper right side of the custom-made titratable mandibular advancement device.
Figure 3
Figure 3
The individual oral appliance (OA) efficacy percentages plotted against the individual OA compliance data, expressed in percentage of days of OA use per week.
Figure 4
Figure 4
Mean disease alleviation (MDA) is equal to the surface area of the rectangle for which the length is given by the adjusted compliance (objective oral appliance (OA) use/total sleep time), and the height is given by the therapeutic efficacy (AHI baseline minus AHI with OA applied, expressed in percentage). MDA provides a measure of overall therapeutic effectiveness.

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