Objectively measured vs self-reported compliance during oral appliance therapy for sleep-disordered breathing.
BACKGROUND
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.


METHODS
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.


RESULTS
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%.


CONCLUSIONS
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.


BACKGROUND
ClinicalTrials.gov; No.: NCT01284881; URL: www.clinicaltrials.gov.
Department of Special Care Dentistry, Antwerp University Hospital, Edegem; Faculty of Medicine and Health Sciences, University of Antwerp, Antwerp, Belgium. Electronic address: Marijke.Dieltjens@uza.be.
Marijke
M
Dieltjens
Department of Special Care Dentistry, Antwerp University Hospital, Edegem; Faculty of Medicine and Health Sciences, University of Antwerp, Antwerp, Belgium.
Marc J
MJ
Braem
Department of Otolaryngology and Head and Neck Surgery, Antwerp University Hospital, Edegem; Faculty of Medicine and Health Sciences, University of Antwerp, Antwerp, Belgium.
Anneclaire V M T
AVMT
Vroegop
Department of Scientific Coordination and Biostatistics, Antwerp University Hospital, Edegem.
Kristien
K
Wouters
Department of Pneumology, Antwerp University Hospital, Edegem; Multidisciplinary Sleep Disorders Center, Antwerp University Hospital, Edegem; Faculty of Medicine and Health Sciences, University of Antwerp, Antwerp, Belgium.
Johan A
JA
Verbraecken
Department of Pneumology, Antwerp University Hospital, Edegem; Multidisciplinary Sleep Disorders Center, Antwerp University Hospital, Edegem; Faculty of Medicine and Health Sciences, University of Antwerp, Antwerp, Belgium.
Wilfried A
WA
De Backer
Department of Otolaryngology and Head and Neck Surgery, Antwerp University Hospital, Edegem; Multidisciplinary Sleep Disorders Center, Antwerp University Hospital, Edegem; Faculty of Medicine and Health Sciences, University of Antwerp, Antwerp, Belgium.
Paul H
PH
Van de Heyning
Department of Otolaryngology and Head and Neck Surgery, Antwerp University Hospital, Edegem; Multidisciplinary Sleep Disorders Center, Antwerp University Hospital, Edegem; Faculty of Medicine and Health Sciences, University of Antwerp, Antwerp, Belgium.
Olivier M
OM
Vanderveken
D045422:Continuous Positive Airway Pressure / Q000295:instrumentation*; D004867:Equipment Design; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D008297:Male; D008875:Middle Aged; D008991:Monitoring, Physiologic; D010349:Patient Compliance; D017286:Polysomnography; D011446:Prospective Studies; D057566:Self Report; D012890:Sleep; D012891:Sleep Apnea Syndromes / Q000503:physiopathology / Q000628:therapy*; D016896:Treatment Outcome