Emami Elham, Nguyen Phan The Huy, Almeida Fernanda R, Feine Jocelyne S, Karp Igor, Lavigne Gilles, Huynh Nelly
Faculty of Dentistry, Université de Montréal, 2900 Edouard-Montpetit, Montreal, QC H3T 1J4, Canada.
Trials. 2014 Sep 13;15:358. doi: 10.1186/1745-6215-15-358.
Edentulism and sleep disturbance are chronic conditions that are common in older people and have serious adverse consequences for their functioning and quality of life. Edentulism can disturb sleep through the alteration of the craniofacial structure and surrounding soft tissue. However, the effect of prosthetic rehabilitation of edentulism on sleep quality is still not well understood. The objectives of this study are to test whether nocturnal denture wear affects sleep quality, daytime sleepiness, and the oral health related quality of life of edentate older people with moderate to severe sleep apnea, and to identify modifiers of effect of nocturnal denture wear.
METHODS/DESIGN: We will carry out a single-blind randomized cross-over trial. Seventy edentate older people with moderate to severe obstructive sleep apnea will be enrolled. The study participants will be assigned to wear and not wear their dentures on alternate periods of 30 days. The outcome measures will be sleep quality (assessed by portable polysomnography), daytime sleepiness (assessed by the Epworth Sleepiness Scale), and oral health related quality of life (assessed by validated questionnaire). A number of characteristics (sociodemographic, oropharyngeal morphology, oral and prosthesis characteristics, and perceived general health quality of life) will be assessed by means of clinical examination, 3D imaging of the craniofacial structure, and validated questionnaires at baseline. Linear mixed effects regression models for repeated measures will be fitted to test the study hypotheses. The main analyses will be based on the intention-to-treat principle. To assess the robustness of the findings to potential incomplete adherence, sensitivity analyses will be conducted while applying the per-protocol principle.
This practice-relevant evidence could represent a preventive approach to improve sleep characteristics of the older population and improve their well-being and quality of life.
ClinicalTrials.gov NCT01868295.
无牙颌和睡眠障碍是老年人常见的慢性疾病，对其功能和生活质量有严重不良影响。无牙颌可通过改变颅面结构和周围软组织来干扰睡眠。然而，无牙颌的修复性康复对睡眠质量的影响仍未得到充分理解。本研究的目的是测试夜间佩戴假牙是否会影响中度至重度睡眠呼吸暂停的无牙老年患者的睡眠质量、日间嗜睡程度以及与口腔健康相关的生活质量，并确定夜间佩戴假牙效果的调节因素。
方法/设计：我们将进行一项单盲随机交叉试验。将招募70名患有中度至重度阻塞性睡眠呼吸暂停的无牙老年患者。研究参与者将被安排在交替的30天时间段内佩戴和不佩戴假牙。结局指标将包括睡眠质量（通过便携式多导睡眠图评估）、日间嗜睡程度（通过爱泼华嗜睡量表评估）以及与口腔健康相关的生活质量（通过经过验证的问卷评估）。在基线时，将通过临床检查、颅面结构的3D成像以及经过验证的问卷来评估一些特征（社会人口统计学、口咽形态、口腔和假牙特征以及感知的总体健康生活质量）。将拟合重复测量的线性混合效应回归模型来检验研究假设。主要分析将基于意向性分析原则。为了评估研究结果对潜在不完全依从性的稳健性，将在应用符合方案原则的同时进行敏感性分析。
这一与实践相关的证据可能代表一种预防性方法，以改善老年人群的睡眠特征，提高他们的幸福感和生活质量。
ClinicalTrials.gov NCT01868295。
