Slow-Paced Respiration for Treatment of Menopausal Hot Flashes

慢速呼吸治疗更年期潮热

基本信息

批准号：
8296511
负责人：
Deborah G Grady
金额：
$ 34.61万
依托单位：
UNIVERSITY OF CALIFORNIA, SAN FRANCISCO
依托单位国家：
美国
项目类别：
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/8296511
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

项目摘要

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.

多达三分之二的美国女性在更年期期间会出现潮热现象，其中 20% 的女性会出现潮热症状，需要接受治疗。尽管绝经后激素疗法是一种有效的治疗方法，但它会增加出现各种严重不良反应的风险。目前迫切需要有效、安全且易于使用的替代疗法，此前的小型临床试验报告称，缓慢呼吸（慢节奏呼吸）可以通过减少交感神经系统活动来显着降低潮热频率。已发现患有潮热的女性的频率增加，但很少使用定速呼吸来治疗潮热，因为支持疗效的数据有限，并且没有明确的描述来提供如何教授或学习该技术的明确证据。为了验证使用慢速呼吸治疗潮热的有效性和可行性，我们建议使用简单、易于使用的设备（RESPeRATE¿ ，Intercure Inc.），引导用户将呼吸减慢至每分钟 10 次呼吸 (BPM) 以下。该设备已上市（Costco、亚马逊），并已获得 FDA 批准用于治疗轻度高血压，包括皮带式设备。放置在衣服上胸部周围的呼吸传感器，以及一个通过耳机感应用户生成音乐模式的小型计算机化盒子。当用户呼吸时，设备会将其音乐音调与用户同步。当用户遵循音乐音调的模式时，呼吸频率会减慢，呼气时间会延长。对于拟议的临床试验，我们将招募 120 名每天至少有 4 次绝经期潮热的女性，并将她们随机分组。使用该设备每天练习慢节奏呼吸 15 分钟，持续 12 周，或使用该设备练习每天听轻松的音乐而不调整呼吸节奏 15 分钟我们的具体目标是：1) 确定使用 RESPeRATE 设备进行慢速呼吸以减少潮热频率的功效（使用动态胸骨皮肤电导监测仪进行测量）；2) 确定慢速呼吸的功效； - 使用 RESPeRATE 控制与潮热相关的其他症状和生活质量结果（即自我报告的潮热严重程度、潮热的烦人程度、困难睡眠、更年期相关的生活质量、抑郁症状和焦虑症状（通过经过验证的问卷测量）；3) 确定随着呼吸节奏的潮热频率的改善是否是通过交感神经系统活动的减少、副交感神经的相对增加来介导的这项研究将明确证明这种针对自主神经系统活动的新型行为干预措施是否可以有效且可行地替代雌激素来缓解潮热。