JAMA Otolaryngol Head Neck Surg. 2015 Oct;141(10):894-900. doi: 10.1001/jamaoto.2015.1756.
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.
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.
Oral appliance therapy with a custom-made, titratrable mandibular advancement device (OAm).
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).
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).
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.
clinicaltrials.gov Identifiers: NCT01284881 and NCT01532050.
报告中断口腔矫治器治疗睡眠呼吸障碍（SDB）的主要原因是存在自我感知的不良反应和自我感知的疗效不足。然而，这些结论仅依赖于主观的依从性数据。
确定哪些参数与口腔矫治器治疗的客观依从性数据相关。
设计、地点和参与者：2011 年 2 月 7 日至 2013 年 10 月 8 日，安特卫普大学医院对 51 例 SDB 门诊患者进行了一项前瞻性临床试验，采用口腔矫治器治疗（38 例[75%]为男性；平均[标准差]年龄为 49.3[9.0]岁；平均[标准差]呼吸暂停低通气指数为每小时睡眠 14.9[9.3]次；平均[标准差]体重指数[体重以千克为单位除以身高以米为单位的平方计算]为 26.3[2.8]）。分析于 2014 年 11 月 5 日进行。
定制、可滴定的下颌前伸装置（OAm）的口腔矫治器治疗。
评估客观依从性与患者的人体测量特征、多导睡眠图参数以及 3 个主观问卷（打鼾视觉模拟量表、嗜睡量表和不良反应问卷）之间的可能相关性。
在 3 个月的随访中，口腔矫治器的中位使用时间为每晚 6.4 小时（范围为每晚 4.7-7.2 小时）。没有一个人体测量和多导睡眠图参数与依从性相关。客观依从性与日间嗜睡报告之间没有相关性。然而，客观依从性与治疗后打鼾的视觉模拟量表评分呈显著负相关（P =.006；ρ= –.40）。此外，客观依从性与社交干扰性打鼾的显著降低显著相关（P =.005；ρ= 0.39）。口干是唯一在 3 个月随访时与客观依从性呈负相关的不良反应（P <.05；ρ= –.31）。
口腔矫治器治疗期间，人体测量和多导睡眠图参数以及日间嗜睡报告均与依从性无关。与口腔矫治器治疗期间更高的客观依从性相关的两个参数是打鼾程度的显著降低和治疗期间口干的出现。
clinicaltrials.gov 标识符：NCT01284881 和 NCT01532050。
