Effects of SinuSonic on Psychological and Physical Well-Being In Adults With Nasal/Sinus Congestion
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 16
- 试验地点
- 1
- 主要终点
- Change in the Anxiety Subscale of the Hospital Anxiety and Depression Scale
研究概览
简要总结
The goal of this clinical trial is to evaluate the effects of using the SinuSonic on psychological and physical well-being in adults who have nasal/sinus congestion.
The study aims are:
- Aim #1: to evaluate the effect of the SinuSonic on physical and psychological well-being in individuals with chronic nasal congestion;
- Aim #2: to evaluate the relationship between autonomic reactivity and psychological well-being (i.e., anxiety and depression) in individuals with chronic nasal congestion;
- Exploratory Aim: to evaluate the impact of adverse experiences on physical and psychological well-being in individuals who experience chronic nasal congestion.
Participants will be asked to complete self-report measures of physical health, mental health and autonomic regulation before using SinuSonic (i.e., baseline research session) and after 5 weeks of directed use (post-intervention). Demographic information and adverse experiences will be documented during the baseline research session. Participants will be asked to document (weekly) current nasal symptoms and SinuSonic usage.
详细描述
All data collection will occur remotely using REDCap (via University of North Carolina, Chapel Hill) and SinuSonic use will take place in participants' homes. As this is a single-arm, feasibility/pilot study, all participants will follow the same protocol.
- Baseline Research Session: self-report completion of demographic information, health information [Short Form Health Survey (SF-20), Total Nasal Symptom Score (TNSS)], autonomic reactivity (Body Perception Questionnaire, BPQ), anxiety/depression (Hospital Anxiety and Depression Scale, HADS), and adverse experiences (Adverse Traumatic Experiences Scale, ATES).
- Begin use of SinuSonic twice per day, every day, for 5 weeks. Duration of each use is approximately 2 minutes. During these 5 weeks, participants will be asked to complete weekly forms to document SinuSonic usage and current nasal symptoms [Patient Global Impression of Change (PGIC), Total Nasal Symptom Score (TNSS).
- Post-intervention Research Session: after 5 weeks of SinuSonic use, self-report completion of symptoms (PGIC, TNSS), autonomic reactivity (BPQ) and anxiety/depression (HADS).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18 years or older;
- •US resident;
- •Currently experiencing symptoms of nasal congestion that have persisted at least 2 weeks. Symptom severity must be rated at least 5, on a visual scale ranging from 1 to 10, as included in a question in the Eligibility Screening.
排除标准
- •Previous use of the SinuSonic device.
- •Meeting any of the conditions listed under the "Safety and Warnings" for using the SinuSonic device:
- •Current or history of breathing problems (i.e., asthma, chronic obstructive pulmonary disorder (COPD), chronic bronchitis, emphysema, pneumonia, pleural effusion, lung cancer, cancer of the throat or upper airway)
- •Current or history of circulatory problems (i.e., active nose bleed, heart arrhythmia, coronary artery disease, congestive heart failure, heart attack)
- •Other conditions, specified as brain tumor, moderate to severe ear pain, fever greater than 101 degrees
- •Pregnant or nursing women
结局指标
主要结局
Change in the Anxiety Subscale of the Hospital Anxiety and Depression Scale
时间窗: Baseline, 5 weeks
The Anxiety Subscale of the Hospital Anxiety and Depression Scale (HADS) is a 7-item self-report questionnaire measuring the frequency of anxiety over the prior week. The anxiety subscale ranges from 0 to 21, with higher scores indicating higher anxiety complaints. Repeated measures ANOVA will be used to evaluate significant differences in change scores using a 0.05 significance level.
Change in the Depression Subscale of the Hospital Anxiety and Depression Scale
时间窗: Baseline, 5 weeks
The Depression Subscale of the Hospital Anxiety and Depression Scale (HADS) is a 7-item self-report questionnaire measuring the frequency of depression over the prior week. The depression subscale ranges from 0 to 21, with higher scores indicating higher depression complaints. Repeated measures ANOVA will be used to evaluate significant differences in change scores using a 0.05 significance level.
次要结局
- Change in the Body Perception Questionnaire(Baseline, 5 weeks)
- Change in the Total Nasal Symptom Score(Baseline, 5 weeks)
- Adverse Traumatic Experiences Survey at Baseline(Baseline)
- Short Form Health Survey (SF-20) at Baseline(Baseline)
- Change in the Body Perception Questionnaire(Baseline, 5 weeks)
- Change in the Total Nasal Symptom Score(Baseline, 5 weeks)
- Change in the Patient Global Impression of Change(Week 1, Week 5)
- Adverse Traumatic Experiences Survey at Baseline(Baseline)
- Short Form Health Survey (SF-20) at Baseline(Baseline)