Slow-Paced Respiration for Treatment of Menopausal Hot Flashes

慢速呼吸治疗更年期潮热

• 批准号: 8104715
• 负责人: Deborah G Grady
• 金额: $ 35.76万
• 依托单位: UNIVERSITY OF CALIFORNIA, SAN FRANCISCO
• 依托单位国家: 美国
• 财政年份: 2011
• 资助国家: 美国
• 起止时间: 2011-07-15 至 2014-03-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8104715
• 关键词: Address; Adherence; Adverse effects; Affect; Alternative Therapies; Anxiety; Autonomic nervous system; Beck depression inventory; Behavior Therapy; Blinded; Blood Pressure; Boxing; Breathing; Carbon Dioxide; Cerebrovascular Disorders; Chest; Clinical Trials; Clothing; Consensus; Coronary; Data; Dementia; Devices; Educational process of instructing; Endometrial Carcinoma; Endometrial Hyperplasia; Enrollment; Epinephrine; Estrogens; Event; Feasibility Studies; Frequencies; Galvanic Skin Response; Health Care Costs; Home environment; Hospitals; Hot flushes; Hour; Hypertension; Learning; Measures; Mediating; Menopause; Mental Depression; Monitor; Morbidity - disease rate; Music; Neuraxis; Norepinephrine; Outcome; Patient Self-Report; Pattern; Perimenopause; Phase; Postmenopause; Progestins; Quality of life; Questionnaires; Randomized; Relative (related person); Reporting; Research; Respiration; Risk; Self-Administered; Severities; Sleep; Sleeplessness; Sympathetic Nervous System; Symptoms; Techniques; Thromboembolism; United States; United States Food and Drug Administration; Venous; Woman; alternative treatment; clinically significant; computerized; cost effective; depressive symptoms; diaries; effective therapy; experience; expiration; heart rate variability; hormone therapy; improved; indexing; malignant breast neoplasm; novel; pressure; programs; respiratory; sensor; trial comparing; urinary

Hot flashes occur in as many as two thirds of U.S. women during menopause and are severe enough to require treatment in 20%. Although postmenopausal hormone therapy is an effective treatment, it is associated with increased risk for a variety of serious adverse effects. There is currently an urgent need for alternative treatments that are effective, safe, and easy to use. Prior small clinical trials have reported that slow breathing (slow-paced respiration) can significantly reduce the frequency of hot flashes by reducing sympathetic nervous system activity, which has been found to be increased in women with hot flashes. However, paced respiration is rarely used to treat hot flashes, because data supporting efficacy are limited, and there is no clear description of how to teach or learn the technique. To provide clear evidence of the efficacy and feasibility of using slow-paced respiration to treat hot flashes, we propose to conduct a rigorous randomized, blinded trial using a simple, easy-to-use device (RESPeRATE¿, Intercure Inc.), that guides users to slow their respiration below 10 breaths per minute (BPM). The device, which is commercially available (Costco, Amazon) and approved by the FDA for treatment of mild hypertension, includes a belt-type respiration sensor that is placed around the chest over clothing, along with a small computerized box that generates musical patterns through earphones. Sensing the user¿s respiration, the device synchronizes its musical tones to the user¿s inspiratory and expiratory phases. As the user follows the pattern of the musical tones, respiratory rate is slowed and expiration is prolonged. For the proposed clinical trial, we will enroll 120 women with at least 4 menopausal hot flashes per day and randomize them either to use the device to practice slow-paced respiration for 15 minutes per day for 12 weeks, or to use the device to practice listening to relaxing music without pacing respiration for 15 minutes per day for 12 weeks. Our specific aims are to: 1) determine the efficacy of slow-paced respiration using the RESPeRATE device to reduce the frequency of hot flashes (measured using an ambulatory sternal skin conductance monitor); 2) determine the efficacy of slow-paced respiration using RESPeRATE on other symptom and quality-of-life outcomes associated with hot flashes (i.e., self-reported severity of hot flashes, bothersomeness of hot flashes, difficulty sleeping, menopause-related quality of life, depression symptoms, and anxiety symptoms as measured by validated questionnaires); and 3) determine if improvement in frequency of hot flashes with paced respiration is mediated by reduction in sympathetic nervous system activity, relative increase in parasympathetic activity, or parameters of slow-paced respiration. This research will definitively demonstrate whether this novel behavioral intervention that targets autonomic nervous system activity offers an effective and feasible alternative to estrogen for alleviation of hot flashes.

在绝经期间，多达三分之二的美国妇女发生了热闪光，并且很严重，需要在20％的情况下进行治疗。尽管绝经后同性恋治疗是一种有效的治疗方法，但它与各种严重不良反应的风险增加有关。目前迫切需要有效，安全且易于使用的替代治疗。先前的小型临床试验报告说，缓慢的呼吸（缓慢呼吸）可以通过减少交感神经系统活动来显着降低潮热的频率，这已经发现，在患有潮热的女性中，这种活动已增加。但是，由于数据支持有限的有限，因此很少使用节奏的呼吸来治疗潮热，并且没有清楚地描述如何教授或学习该技术。为了清楚地证明使用缓慢节奏的呼吸治疗热闪光的有效性和可行性，我们建议使用简单，易于使用的设备（Resperate，Intercure Inc.）进行严格的随机，盲试验，以指导用户减慢其呼吸速度以下10次呼吸10次呼吸（BPM）。该设备可商购（Costco，Amazon），并由FDA批准用于治疗轻度高血压，其中包括腰带式呼吸传感器，该呼吸传感器位于胸部周围的衣服上，以及一个小型计算机盒，可通过耳机产生音乐图案。该设备感知用户的呼吸，将其音乐音调同步到用户的灵感和到期阶段。随着用户遵循音乐音调的模式，呼吸速度缓慢，到期延长。对于拟议的临床试验，我们将每天至少注册120名具有至少4次绝经的女性，并随机将其随机使用该设备以每天15分钟的速度呼吸练习12周，或者使用该设备每天练习轻松的音乐，而无需每天的节奏呼吸，每天练习15分钟，持续15分钟。我们的具体目的是：1）确定使用恢复装置降低热闪光频率的缓慢呼吸的效率（使用卧床细长的皮肤电导显示器测量）； 2）确定使用其他症状和与潮热相关的其他症状和生活质量结果（即自我报告的炎热闪光的严重程度，炎热闪光，困难的睡眠，与绝经相关的生活质量，与抑郁症状，抑郁症状，以及经过验证的问题测量的焦虑症状相关的两种症状）确定缓慢节奏的呼吸效率； 3）确定呼吸节奏呼吸的热闪光的频率是否通过减少交感神经系统活动，副交感神经活动的相对增加或慢节奏呼吸的参数来介导。这项研究将一定会证明针对自主神经系统活动的这种新颖的行为干预是否为减轻热闪光的雌激素提供了有效且可行的替代方法。