NCT03039231已完成不适用
Investigation of the Freespira Breathing System in the Treatment of PTSD
Palo Alto Health Sciences, Inc.2 个研究点 分布在 1 个国家目标入组 55 人开始时间: 2017年2月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 55
- 试验地点
- 2
- 主要终点
- Primary outcome of this study will be quantitative improvements using the Clinician Administered PTSD Scale (CAPS - 5).
研究概览
简要总结
This study will test the efficacy of the Freespira Breathing System in adults with post traumatic stress disorder (PTSD).
详细描述
The Freespira Breathing System (FBS) developed by Palo Alto Health Sciences, Inc, is a portable home device , and has been employed in breathing biofeedback in adults with panic disorder (PD). The FBS has received FDA clearance for the treatment of PD adults and is currently commercially available.
This study is a prospective, single arm, un-blinded investigation of the Freespira Breathing System in the PTSD population.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Note: Office visits required. Patients must live locally in San Francisco/Silicon Valley Bay Area to participate.
- •Patients with a primary diagnosis of PTSD
- •Additional DSM-V disorders are acceptable and will be documented.
- •Subjects over 18 years of age
- •Subjects with a Clinician's Global Impression (CGI-S) score of ≥ 4
- •Subjects with a CAPS-5 score of ≥ 30
- •If on psychotropic medication(s), on a stable dose during the course of treatment
- •This can include benzodiazepine use that is prescribed on an as needed basis. • If on psychotropic medication(s), patient agreement to maintain their current stable dose from point of study entry until the 2-month post-treatment assessment.
排除标准
- •Subject is pregnant.
- •Current enrollment in another device or drug study.
- •Enrollment in another drug or device study that is not at least 30 days past the final follow-up visit.
- •Currently undergoing cognitive behavioral therapy, or equivalent that is focused addressing PTSD including any evidenced based therapy that focuses on PTSD, including cognitive processing therapy, EMDR, prolonged exposure therapy, Virtual reality therapy, during trial and 2 month follow up. Cognitive therapy must be discontinued 1 month prior to enrolling in this study.
- •Severe suicidality, in the judgment of the interviewer and taking the CHART assessment into account
- •Psychotic disorder diagnosis, including schizophrenia and schizoaffective disorder
- •Presence of uncontrolled bipolar disorder as described below -
- •The subject has experienced a manic episode in the past 6 months and is not considered under control by reviewer
- •Bipolar disorder is considered the primary diagnosis for the subject, in the interviewer's opinion.
- •No Alcohol, drug use disorder that requires medical treatment . If stable under medical supervision treatment for drug/alcohol use, then OK
- •Cardiovascular or pulmonary disease, such as COPD.
- •Score of ≥ 10 on the COPD assessment
- •EtCO2 of ≥ 48 mmHg at first treatment visit
- •Epilepsy or seizures
- •Inability to understand or comply with study procedures.
- •The investigator feels that for any reason the subject is not eligible to participate in the study.
结局指标
主要结局
Primary outcome of this study will be quantitative improvements using the Clinician Administered PTSD Scale (CAPS - 5).
时间窗: 2 month and 6 months post treatment
Using this scale, Response is defined as a reduction of 6 or more points. Remission is defined as Response plus no longer meeting clinical symptom criteria and having a severity score \< 25.
次要结局
- Change in Patient Health Questionnaire (PHQ-9) Score(2 month and 6 months post treatment)
- Change in 36-Item Short Form Survey (SF-36) Score(2 month and 6 months post treatment)
- Change in Clinical Global Impression (CGC-S) Score(2 month and 6 months post treatment)
- Change in Panic Disorder and Severity Scale (PDSS) Score(2 month and 6 months post treatment)
- Proportion achieving "Remission" by CAPS-5 Score(2 month and 6 months post treatment)
研究者
研究点 (2)
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