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

项目总结摘要 口咽头颈部癌在美国已经上升到流行水平。 尽管癌症治疗反应良好，但仍有3名幸存者遭受着导致吞咽的终生毒副作用。 问题(吞咽困难)。4，5 OP HNC后吞咽困难的治疗选择极其有限，重点放在 只考虑吞咽动作，而不考虑呼吸-吞咽相模式的重要性。6-11 先前的证据已经证明 的 减损， 当出现异常的呼吸-吞咽相图案时(初始 吸入时吞咽)在OP HNC患者中，吞咽的发生率较高 残留物增加，并侵入呼吸道。12，13 我 此外，已经很好地确定了呼气 呼吸周期的四肢提供了一个生物力学上有利的设定点，在这个设定点上启动安全和 14-17因此，我们开发并测试了一种创新的方法来训练个人 吞咽困难后的OP HNC开始吞咽在呼气。18在这项初步试验中，我们发现训练 呼气时开始吞咽可显著改善呼吸道保护和关键 吞咽功能的生理成分。18这些令人信服的发现使我们得出了目前随机、 第二阶段，假对照临床试验，以测试这种呼吸-吞咽阶段训练方法是否会有所改善 OP HNC幸存者在亚急性期(3-6个月)的呼吸道保护和吞咽效率复苏之路。 我们的主要目标(目标1)是确定呼吸-吞咽阶段训练是否导致频率增加(%)。 在呼气过程中开始吞咽，提高了吞咽安全性。我们的次要目标(目标2)是检查 呼吸-吞咽相训练对儿童呼气时吞咽频率的影响 清醒的、自然主义的吞咽环境，包括饮食。我们将招募88名OP HNC幸存者 吞咽困难，呼吸-吞咽相模式受损，呼吸道受损。他们将会是 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，使用 远程健康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的主要终结点：在到期和 穿透-吸引量表19分。次要终点：归一化残留率等级20和修改 吞钡障碍档案21，22分。终端将通过同步视频透视进行测量 在基线、治疗后1周内、1个月和3个月内进行呼吸-吞咽传感器记录 后处理。AIM 2的主要终点是在清醒状态下在呼气期间发起的燕子的频率(%)， 在基线、训练期间、治疗后1周内以及2、4、6、8、10和 治疗后12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 可与传统疗法相结合的选项，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.