Training Swallowing Initiation during Expiration: Impact on Safety and Efficiency Following Treatment for Oropharyngeal Head and Neck Cancer

项目摘要 口咽头颈部癌（OP HNC）在美国已上升至流行水平。 尽管对癌症治疗反应良好，但3名幸存者仍遭受终身毒性，导致吞咽 问题（吞咽困难）。4，5 OP HNC后吞咽困难的治疗选择非常有限，重点是 吞咽运动单独，不考虑吞咽阶段模式的重要性。6 -11 先前的证据表明， 的 损伤， 当存在异常的吞咽阶段模式时（起始 在OP HNC患者中，吞咽的发生率较高 残留物增多和气道侵入12,13 我 此外，已经很好地确定， 呼吸循环的分支提供了生物力学上有利的设定点， 因此，我们开发并测试了一种创新的方法来训练个人， 在这个初步试验中，我们发现，训练 呼气时开始吞咽导致气道保护和关键的改善， 吞咽功能的生理成分。18这些令人信服的发现使我们进行了目前的随机， 第二阶段，假对照临床试验，以测试这种吞咽阶段的训练方法是否会改善 亚急性期（3-6个月）OP HNC幸存者的气道保护和吞咽效率恢复的机会 我们的主要目标（Aim 1）是确定吞咽阶段训练是否会导致频率增加（%） 在呼气期间开始吞咽，并提高吞咽安全性。我们的第二个目标（目标2）是检查 吞咽阶段训练对呼气期间吞咽频率的影响 清醒、自然的吞咽环境，包括进食和饮水。我们将招募88名HNC行动的幸存者 伴有吞咽困难、吞咽-吞咽阶段模式受损和气道受损。他们将 1：1随机分为实验组（n=44）和假手术组（n=44）。我们将远程提供治疗， 远程医疗平台和创新的可穿戴传感器，提供呼吸的实时视觉反馈， 吞咽动作。目标1的主要终点：呼气期间开始吞咽的频率（%）， 穿刺抽吸量表评分19分。次要终点：标准化残差比量表20和改良 钡剂吞咽损伤特征21，22分。终点将通过同步视频荧光透视测量 基线、治疗后1周内以及1个月和3个月时的吞咽传感器记录 后处理。目标2的主要终点是清醒时呼气期间开始吞咽的频率（%）， 在基线、训练期间、治疗后1周内以及治疗后2、4、6、8、10和 12-治疗后数周。与NCI的使命一致，这项拟议的研究调查了一种新的治疗方法 这是一种可以与传统疗法相结合的选择，以改善OP HNC幸存者的吞咽恢复。

PROJECT SUMMARY ABSTRACT Oropharyngeal head and neck cancers (OP HNC) have increased to epidemic levels in the United States.1,2 Despite good response to cancer treatment,3 survivors are suffering life-long toxicities that result in swallowing problems (dysphagia).4,5 Treatment options for dysphagia after OP HNC are extremely limited, focus on swallowing movements alone, and do not consider the importance of respiratory-swallow phase patterning.6-11 Prior evidence has demonstrated that of impairments, when aberrant respiratory-swallow phase patterning is present ( initiation swallowing during nspiration ) in patients with OP HNC, there is a higher occurrence of swallowing increased residue, and airway invasion. 12,13 i Further, it has been well established that the expiratory limb of the respiratory cycle provides a biomechanically advantageous set point in which to initiate safe and efficient swallowing.14-17 Thus, we developed and tested an innovative approach to train individuals with dysphagia after OP HNC to initiate swallowing during expiration.18 In this preliminary trial, we found that training initiation of swallowing during expiration resulted in marked improvements in airway protection and key physiologic components of swallowing function.18 These compelling findings led us to the current randomized, Phase II, sham-controlled clinical trial to test if this respiratory-swallow phase training approach will improve airway protection and swallowing efficiency in OP HNC survivors in the subacute phase (3-6 mo.) of recovery. Our primary goal (Aim 1) is to determine if respiratory-swallow phase training results in increased frequency (%) of swallows initiated during expiration and improved swallowing safety. Our secondary goal (Aim 2) is to examine the impact of respiratory-swallow phase training on the frequency of swallows initiated during expiration in wakeful, naturalistic swallowing environments, including eating and drinking. We will recruit 88 OP HNC survivors with dysphagia, impaired respiratory-swallow phase patterning, and airway compromise. They will be randomized 1:1 into Experimental (n=44) or Sham (n=44) group arms. We will deliver therapy remotely using a telehealth platform and an innovative wearable sensor that provides real-time visual feedback of respiratory- swallow movements. Primary endpoints for Aim 1: frequency (%) of swallows initiated during expiration and Penetration-Aspiration Scale19 scores. Secondary endpoints: Normalized Residue Ratio Scale20 and Modified Barium Swallow Impairment Profile21,22 scores. Endpoints will be measured from synchronized videofluoroscopic and respiratory-swallow sensor recordings at baseline, within 1-week post-treatment, and 1-month and 3-months post-treatment. The primary endpoint for Aim 2 is frequency (%) of swallows initiated during expiration in wakeful, natural contexts measured at baseline, during training, within 1-week post-treatment, and 2-, 4-, 6-, 8-, 10-, and 12-weeks post-treatment. Consistent with the NCI's mission, this proposed study investigates a new therapy option that could be combined with traditional therapies to improve swallowing recovery for survivors of OP HNC.