Novel treatment of sleep apnea by upper airway and respiratory muscle training

项目摘要 标题：通过上气道和呼吸肌治疗睡眠呼吸暂停的新方法 训练 近年来，我们和其他人发现脊髓损伤/疾病（SCI/D）是一种 与睡眠呼吸障碍（SDB）患病率显著增加相关。 近80%的SCI/D患者（包括退伍军人）在6个月后患有SDB （其中大多数70-80%是阻塞性呼吸暂停和呼吸不足-OSA）。 然而，大多数SCI/D患者不能耐受标准SDB治疗（连续 气道正压-CPAP）导致缺乏顺应性。因此，识别 其他疗法对于这种与不良结局相关的常见疾病很重要， 一般人群（心脏病、中风、高血压和认知能力差）。它有 据报道，在睡眠呼吸暂停健全患者中， 使用言语病理学技术治疗3个月可改善SDB的严重程度。 此外，先前的研究表明，呼吸肌训练（RMT）对 增加颈椎脊髓损伤患者的呼吸肌力量。然而， 联合口咽和RMT对SCI患者OSA的影响尚不清楚。 本申请的目的是确定OSA的新治疗干预措施 SCI/D退伍军人的治疗本申请建议进行试点研究， 将30名患有SCI/D和OSA的退伍军人随机分组，接受为期3个月的每日（30分钟） 经验证的口咽和RMT组（干预组）与假手术组的治疗 治疗（对照组）。将有三个具体目标来解决以下问题 假设： 具体目标（1）：测试招募率和试点干预措施的可行性， 包括口咽和RMT联合治疗与假治疗， SCI/D。 具体目的（2）：测试口咽和 SCI/D患者的RMT。 具体目的（3）：确定临床终点的效应量估计值及其 治疗结束时的相关变异性，以计算适当的样本量 一个有充分把握的临床试验

Project Summary Abstract Title: Novel treatment of sleep apnea by upper airway and respiratory muscle training. In recent years, we and others have discovered that spinal cord injury/disease (SCI/D) is associated with significant increase in the sleep-disordered breathing (SDB) prevalence. Nearly 80% of patients with SCI/D including Veterans suffer from SDB after six months of injury (majority of them 70-80% are obstructive apneas and hypopneas-OSA). However, most patients SCI/D do not tolerate standard SDB treatment (continuous positive airway pressure-CPAP) leading to lack of compliance. Therefore, identifying other therapies is important for this common condition that is linked to poor outcome in the general population (heart disease, stroke, hypertension and poor cognition). It has been reported in sleep apnea able-bodied patients that oropharyngeal muscle exercises for 3 months using speech pathology techniques improve the severity of SDB. Furthermore, previous studies showed respiratory muscle training (RMT) is effective for increasing respiratory muscle strength in people with cervical SCI. However, the effect of combined oropharyngeal and RMT on OSA in patients with SCI is unknown. The purpose of this application is to identify new therapeutic interventions for OSA treatment in Veterans with SCI/D. This application proposes for a pilot study to randomizing 30 Veterans with SCI/D and OSA to receive 3 months of daily (30 minutes) treatment with a validated set of oropharyngeal and RMT (intervention arm) versus sham therapy (control arm). There will be three specific aims to address the following hypotheses: Specific Aim (1): To test recruitment rate and feasibility of a pilot intervention that includes combined oropharyngeal and RMT versus sham treatment in individuals with SCI/D. Specific Aim (2): To test the acceptability and usability of combined oropharyngeal and RMT in individuals with SCI/D. Specific Aim (3): To determine the effect size estimates for clinical endpoints and their associated variability at the end of treatment to calculate an appropriate sample size for an adequately powered clinical trial.