Determinants of Objective Compliance During Oral Appliance Therapy in Patients With Sleep-Disordered Breathing: A Prospective Clinical Trial.

Importance: The main reported reasons for discontinuation of oral appliance therapy for sleep-disordered breathing (SDB) are the presence of self-perceived adverse effects and self-appreciated lack of efficacy. However, these conclusions rely only on subjective compliance data.
Objective: To determine which parameters are correlated with objectively measured data on compliance with oral appliance therapy.
Design, Setting, and Participants: For 51 outpatients with SDB, a prospective clinical trial using oral appliance therapy was conducted at Antwerp University Hospital from February 7, 2011, to October 8, 2013 (38 [75%] males; mean [SD] age, 49.3 [9.0] years; mean [SD] apnea-hypopnea index, 14.9 [9.3] events per hour of sleep; mean [SD] body mass index [calculated as weight in kilograms divided by height in meters squared], 26.3 [2.8]). Analysis was performed November 5, 2014.
Intervention: Oral appliance therapy with a custom-made, titratrable mandibular advancement device (OAm).
Main Outcomes and Measures: Possible correlations were assessed between objective compliance and patients’ anthropometric characteristics, polysomnographic parameters, and answers to 3 subjective questionnaires (the visual analog scale for snoring, the Epworth Sleepiness Scale, and an adverse effects questionnaire).
Results: Median oral appliance use was 6.4 hours per night (range, 4.7-7.2 hours per night) at the 3-month follow-up. None of the anthropometric and polysomnographic parameters were correlated with compliance. No correlation was found between objective compliance and reports of excessive daytime sleepiness. However, a significant inverse correlation was found between objective compliance and posttreatment visual analog scale values for snoring (P = .006; ρ = –.40). In addition, objective compliance was correlated significantly with a more pronounced decrease in socially disturbing snoring (P = .005; ρ = 0.39). The presence of dry mouth was the only adverse effect that was negatively correlated with objective compliance at the 3-month follow-up (P < .05; ρ = –.31).
Conclusions and Relevance: Neither the anthropometric and polysomnographic parameters nor reports of excessive daytime sleepiness correlated with compliance during oral appliance therapy. The 2 parameters that were correlated with higher objective compliance during oral appliance therapy were a more pronounced decrease in snoring and the presence of dry mouth during treatment.
Trial Registration: clinicaltrials.gov Identifiers: NCT01284881 and NCT01532050.