CPAP THERAPY FOR HYPERNASALITY IN CLEFT PALATE SUBJECTS

这项研究将评估一个标准化的八周家庭的疗效 持续气道正压通气（CPAP）治疗方案 非综合征型单侧唇腭裂患者的鼻音过度 年龄在6到25岁之间，男女不限。 七裂 腭中心将在临床试验中合作。 参考磁带 将被编译，受试者的语音样本的鼻音评级将被 通过将受试者记录与标准样本进行配对比较获得 在参考磁带上。 所有的语音样本都将以这种方式进行评级， 同样的七个专家听众，每个临床中心一个。 可靠性， 观察者的变异性，以及这些校准评估与 将研究基于临床印象的常规评分。 定时 与CPAP治疗有关的每个语音样本的信息将被隐藏， 听众 该设盲、受控程序的平均言语评分 将是评估CPAP治疗影响的主要结局变量。 将获得标准鼻平衡评分，并测量瞬时鼻平衡。 咽闭合，以及在手术期间保持闭合。 会话语音，将从简短的侧视图中获得 视频透视检查。 这些措施将在以下方面加以研究： 与CPAP治疗相关，并与语音评估数据相关。 患者 将获得与这些结果变量相关的满意度数据。 患者在给定的年龄范围内，没有中耳疾病，一般 中度鼻音过重的患者，将有机会 参加 将使用分级、逐步升级的CPAP治疗计划， 阻力训练的原则 录音样本， 将在基线时进行鼻测量和视频透视。 后续行动 语音样本和鼻音测量数据将在4和8小时后获得。 对于在前18周内接受治疗的患者， 月，在治疗完成后一年。 后处理 将在第8周时获得视频透视和其他数据。 治疗后4个月，受试者将完成一页患者 满意度问卷 主要研究者和其他 伊利诺伊大学的工作人员将对调查人员进行数据培训 收集、准备参考磁带、编辑和复制语音样本 其设施将作为协调和 数据分析中心。 CPAP治疗可能提供一种低成本的家庭治疗方法 用于改善未经证实治疗的患者的生活质量 手术以外的其他选择。

This study will evaluate the efficacy of a standardized eight-week home regimen of continuous positive airway pressure (CPAP) therapy for reduction of hypernasality in nonsyndromic unilateral cleft lip and palate subjects between six and twenty-five years old, and of either sex. Seven cleft palate centers will collaborate in the clinical trial. Reference tapes will be compiled, and nasality ratings of subjects' speech samples will be obtained by paired comparisons of subject recordings with standard samples on reference tapes. All speech samples will be rated in this way by the same seven expert listeners, one per clinical center. Reliability, observer variability, and the relation of these calibrated evaluations to conventional scoring based on clinical impressions will be studied. Timing of each speech sample in relation to CPAP therapy will be concealed from listeners. Mean speech ratings from this blinded, controlled procedure will be a primary outcome variable to assess the impact of CPAP therapy. A standard nasalance score will be obtained and measures of momentary velopharyngeal closure, as well as maintenance of closure during conversational speech, will be obtained from brief lateral view videofluoroscopic examinations. These measures will be studied in relation to CPAP therapy and correlated with speech assessment data. Patient satisfaction data will be obtained and related to these outcome variables. Patients in the given age range, without middle ear disease and generally with moderate hypernasality, will be offered the opportunity to participate. A graded, escalating CPAP therapy program will be used, based on the principles of resistance training. Recorded speech samples, nasometry, and videofluoroscopy will be obtained at baseline. Follow-up speech samples and nasometric data will be obtained after four and eight weeks of therapy and, for patients treated within the first eighteen months, at one year following completion of therapy. Post-treatment videofluoroscopy will be obtained, with the other data, at eight weeks. Four months post-therapy, subjects will complete a one-page patient satisfaction questionnaire. The Principal Investigator and other University of Illinois personnel will train investigators in data collection, prepare reference tapes, compile and replicate speech samples for evaluation, and their facilities will serve as the Coordinating and Data Analysis Center. CPAP therapy may provide a low-cost, at-home method for improving quality of life of patients with no demonstrated treatment alternative other than surgery.