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Original Investigation |

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

Marijke Dieltjens, MBS, PhD1,2,3; Annelies E. Verbruggen, MD2,3; Marc J. Braem, DDS, PhD1,2; Kristien Wouters, PhD4; Johan A. Verbraecken, MD, PhD2,5,6; Wilfried A. De Backer, MD, PhD2,5,6; Evert Hamans, MD, PhD2,3,6; Paul H. Van de Heyning, MD, PhD2,3,6; Olivier M. Vanderveken, MD, PhD2,3,6
[+] Author Affiliations
1Department of Special Care Dentistry, Antwerp University Hospital, Edegem, Antwerp, Belgium
2Translational Neurosciences, Faculty of Medicine and Health Sciences, University of Antwerp, Antwerp, Belgium
3Department of Otolaryngology and Head and Neck Surgery, Antwerp University Hospital, Edegem, Antwerp, Belgium
4Department of Multidisciplinary Sleep Disorders Centre, Antwerp University Hospital, Edegem, Antwerp, Belgium
5Department of Pneumology, Antwerp University Hospital, Edegem, Antwerp, Belgium
6Department of Scientific Coordination and Biostatistics, Antwerp University Hospital, Edegem, Antwerp, Belgium
JAMA Otolaryngol Head Neck Surg. 2015;141(10):894-900. doi:10.1001/jamaoto.2015.1756.
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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 = –0.40). 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 = –0.31).

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

Figures in this Article

Figures

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Figure 1.
CONSORT Diagram

OAm indicates oral mandibular advancement device.

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Figure 2.
Incidence of the Most Frequently Reported Adverse Effects During OAm Therapy

Adverse effects were subjectively scored. Unpleasant sensations in the teeth, pain in the teeth, hypersalivation, and pain in the temporomandibular joint (TMJ) were the most reported adverse effects. OAm indicates oral mandibular advancement device.

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Figure 3.
Correlation Between Objective Mean Wearing Time and Snoring Parameters

The correlation between the objective mean wearing time at the 3-month follow-up visit and scores on the visual analog scale for snoring with the oral mandibular advancement device (OAm) as well as the decrease in scores on the visual analog scale for snoring with the OAm compared with baseline. A, Visual analog scale scores for snoring with the OAm (P = .006; ρ = –0.40). B, Decrease in scores on the visual analog scale for snoring with the OAm compared with baseline (P = .005; ρ = 0.39). A positive value is regarded as a decrease in visual analog scale score.

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