CPAP THERAPY FOR HYPERNASALITY IN CLEFT PALATE SUBJECTS

CPAP 治疗腭裂患者鼻音过多

• 批准号: 2131340
• 负责人: DAVID P KUEHN
• 金额: $ 4万
• 依托单位: UNIVERSITY OF ILLINOIS AT URBANA-CHAMPAIGN
• 依托单位国家: 美国
• 财政年份: 1992
• 资助国家: 美国
• 起止时间: 1992-09-01 至 1998-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/2131340
• 关键词: cleft palate; human subject; human therapy evaluation; longitudinal human study; muscle function; nasopharynx; positive pressure breathing; psychophysics; respiratory airway pressure; respiratory therapy; speech; statistics /biometry; voice

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.

这项研究将评估一个标准化的八周家庭的效果 持续气道正压(CPAP)治疗减压术的方案 非综合征性单侧唇腭裂患者的高鼻音 年龄在六岁到二十五岁之间，不分性别。七条裂隙 味觉中心将在临床试验中进行合作。参考磁带 将被汇编，受试者的语音样本的鼻音评级将被 通过将受试者的录音与标准样品配对比较而获得的 在参考磁带上。所有语音样本都将以这种方式由 同样的七位专家听众，每个临床中心一位。可靠性、 观察者的可变性，以及这些校准的评价与 将研究基于临床印象的常规评分。计时 与CPAP治疗有关的每个语音样本的 听众。来自这个盲目的受控程序的平均语音评级 将是评估CPAP治疗效果的主要结果变量。 将获得标准的鼻音评分，并测量瞬时 腭咽闭合，以及在治疗期间保持闭合 会话演讲，将从简短的横向视角获得 视频透视检查。我们将研究这些措施与 与CPAP治疗相关，并与言语测评数据相关。有耐心的 将获得满意度数据，并将其与这些结果变量相关。 在特定年龄范围内、无中耳疾病和一般情况下的患者 有适度鼻音的人，将有机会 参与进来。将使用分级的、逐步升级的CPAP治疗计划，基于 关于耐力训练的原则。记录的语音样本， 鼻腔测量和视频透视将在基线时获得。跟进 语音样本和鼻音测量数据将在四点和八点后获得 几周的治疗，对于在前十八个月内治疗的患者 3个月，在完成治疗后一年。后处理 视频透视将在8周后与其他数据一起获得。 治疗四个月后，受试者将完成一页的患者 满意度调查问卷。首席调查员和其他 伊利诺伊大学工作人员将对调查人员进行数据培训 收集、制作参考磁带、汇编和复制演讲样本 进行评估，他们的设施将作为协调和 数据分析中心。CPAP疗法可能提供一种低成本的居家治疗方法 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。