title: Objective measurement of compliance during oral appliance therapy for sleep-disordered breathing.
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.
authors.affiliation: Department of Otolaryngology and Head and Neck Surgery, Antwerp University Hospital, Antwerp, Belgium. olivier.vanderveken@uza.be
authors.forename: Olivier M
authors.initials: OM
authors.lastname: Vanderveken
authors.forename: Marijke
authors.initials: M
authors.lastname: Dieltjens
authors.forename: Kristien
authors.initials: K
authors.lastname: Wouters
authors.forename: Wilfried A
authors.initials: WA
authors.lastname: De Backer
authors.forename: Paul H
authors.initials: PH
authors.lastname: Van de Heyning
authors.forename: Marc J
authors.initials: MJ
authors.lastname: Braem
mesh_terms: D000328:Adult; D045422:Continuous Positive Airway Pressure / Q000379:methods; D004867:Equipment Design; D004869:Equipment Safety; D005260:Female; D006801:Humans; D008297:Male; D055617:Micro-Electrical-Mechanical Systems; D008875:Middle Aged; D008991:Monitoring, Physiologic / Q000379:methods; D009967:Orthodontic Appliances; D010349:Patient Compliance / Q000706:statistics & numerical data*; D017286:Polysomnography / Q000379:methods; D011446:Prospective Studies; D012720:Severity of Illness Index; D012891:Sleep Apnea Syndromes / Q000175:diagnosis / Q000628:therapy*; D013821:Thermometers