Objectively Measured vs Self-Reported Compliance During Oral Appliance Therapy for Sleep-Disordered Breathing

• DOI: 10.1378/chest.13-0613
• Publication Date: 2013-08-09T07:31:12Z
• Authors: Marijke Dieltjens; Marc J. Braem; Anneclaire V.M.T....; Kristien Wouters; Johan A. Verbraecken; Wilfried A. De Ba...; Paul H. Van de He...; Olivier M. Vander...
• Keywords: Male; Continuous Positive Airway Pressure; Polysomnography; Equipment Design; Middle Aged; 3. Good health; 03 medical and health sciences; Sleep Apnea Syndromes; Treatment Outcome; 0302 clinical medicine; Humans; Patient Compliance; Female; Human medicine; Prospective Studies; Self Report; Sleep; Follow-Up Studies; Monitoring, Physiologic

Assessment of the overall therapeutic effectiveness of oral appliance therapy can only be realized through objectively measured compliance. The aims of this study were to assess objectively measured compliance during oral appliance therapy at 1-year follow-up and to compare these data with self-reported use.Fifty-one eligible patients were enrolled in this 1-year prospective clinical study (men, 61%; mean age, 49 ± 10 years; apnea-hypopnea index, 18.0 ± 11.9 events/h sleep; BMI, 26.6 ± 4.1 kg/m²). Objective compliance during oral appliance therapy at 1-year follow-up was assessed with a microsensor thermometer. Subjective compliance was assessed by self-report. Patients with a mean objectively measured use of ≥ 4 h/night on 70% of nights monitored were considered regular users. The mean disease alleviation was calculated as a measure of overall therapeutic effectiveness.High agreement between objective and subjective compliance data at 1-year follow-up was reported (intraclass correlation coefficient, 0.8; 95% CI, 0.5-0.9), showing a mean subjective overestimation of 30 min (95% CI, -3.1 to 1.9; P = .02). The discontinuation rate at 1-year follow-up was 9.8%. The objective mean use rate was 6.4 ± 1.7 h/night at 1-year follow-up in continuing users, with a regular use rate of 83%. The mean disease alleviation was 54.9%.This study is the first to our knowledge to report the 1-year results of objectively measured compliance during oral appliance therapy. In addition, a high agreement between objective and subjective compliance data were reported, with a mean subjective overestimation of 30 min.ClinicalTrials.gov; No.: NCT01284881; URL: www.clinicaltrials.gov.