Impact of Vagal Approaches on Symptomatology in Long COVID Participants
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 546
- 试验地点
- 1
- 主要终点
- Heart Rate Variability (HRV)
研究概览
简要总结
The purpose of this study is to explore whether two general wellness products, alone or combined, can support individuals experiencing Long COVID symptoms. Both wellness products stimulate the vagus nerve - a nerve that helps regulate stress, relaxation, mood, breathing, heart rate, inflammation, and digestion.
The investigators will use a Fitbit to track participants' health measurements including, but not limited to, activity, heart rate, and heart rate variability, and participants will be asked to complete surveys about their experience. This information will be collected into a repository where participants can share their experiences with Long COVID symptoms.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 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
- •Tested positive by any test for acute COVID-19 and/or have ICD-10 code for COVID-19 in their electronic health records (EHR)
- •Any patient having the ICD-10 code for post-acute sequelae of COVID-19 (PASC) within their EHR, or any patient who has evidence of a Long COVID clinic visit within their EHR
- •Have persistent COVID-19 symptoms 3 months following resolution of acute COVID-19 infection as indicated by a negative COVID-19 test
- •Self-identified as having Long COVID based on symptomology:
- •a. Symptoms must include any combination of the following: (ICD-10 codes shown):
- •Shortness of breath (R06.02, R06.00, or R06.09)
- •Fatigue (R53.83, or R53.82)
- •Cognitive impairment (G31.84 or R41.9)
- •Mental, Behavioral, and Neurodevelopmental disorders (F01-F99)
- •Postural orthostatic tachycardia syndrome (POTS) (I49.8)
- •Participants must have auditory headphones; over the ear headphones or earbuds
- •Participants must be at least 18 years of age, inclusive, at the time of signing the informed consent
- •Capable of understanding and providing signed informed consent
- •Participants must have a smart phone
- •Reliable access to internet via browser installed on a smartphone
排除标准
- 未提供
研究组 & 干预措施
Sonocea Sonic Augmentation Technology (SAT) General Wellness Product
Participants enrolled in this arm will listen to a sound-based approach, delivered via headphones through a smartphone application. The session participants will listen to consists of structured music soundscapes that have been standardized in format, intensity, and duration for research purposes.
干预措施: Sonocea Sonic Augmentation Technology (SAT) (Other)
Truvaga Electrical Vagus Nerve Stimulator General Wellness Product
Participants enrolled in this arm will use the Truvaga Electrical Vagus Nerve Stimulator general wellness product, which sends gentle electrical signals through the skin to stimulate the vagus nerve on the neck.
干预措施: Truvaga Electrical Vagus Nerve Stimulator (Other)
Sonocea SAT + Truvaga Electrical Vagus Nerve Stimulator General Wellness Products
Participants enrolled in this arm will use both the Sonocea SAT and Truvaga Electrical Vagus Nerve Stimulator general wellness products.
干预措施: Sonocea Sonic Augmentation Technology (SAT) (Other)
Sonocea SAT + Truvaga Electrical Vagus Nerve Stimulator General Wellness Products
Participants enrolled in this arm will use both the Sonocea SAT and Truvaga Electrical Vagus Nerve Stimulator general wellness products.
干预措施: Truvaga Electrical Vagus Nerve Stimulator (Other)
Control (No Intervention)
Participants enrolled in this arm will not use either wellness product.
结局指标
主要结局
Heart Rate Variability (HRV)
时间窗: Weekly
Heart rate variability (HRV) is a widely recognized biomarker for autonomic nervous system regulation. Long COVID is commonly associated with reduced HRV, reflecting autonomic nervous system dysregulation. Lower HRV in these patients has been linked to greater symptom burden.
Cardio Score (VO2 Max)
时间窗: Weekly
Tracking changes in estimated aerobic capacity can help evaluate whether approaches are improving cardiovascular function and exercise tolerance over time.
SpO2
时间窗: Weekly
SpO2 measures blood oxygen saturation levels, indicating how well oxygen is being transported throughout the body.
Patient Health Questionnaire-8 (PHQ-8)
时间窗: Week 0, Week 4 and Week 8
The PHQ-8 is a gold-standard screening tool for major depressive disorder, endorsed by the CDC and WHO, with strong criterion validity and sensitivity to clinical change.
Generalized Anxiety Disorder-7 (GAD-7)
时间窗: Week 0, Week 4 and Week 8
The GAD-7 captures both somatic and cognitive components of generalized anxiety. Extensively used in both clinical and epidemiological contexts, the GAD-7 shows excellent internal consistency (α \> 0.90) and convergent validity with clinician-administered diagnostic tools.
PTSD Checklist for DSM-5 Short Form (Abbreviated PCL-5)
时间窗: Week 0, Week 4 and Week 8
The Abbreviated PCL-5 captures re-experiencing, avoidance, hyperarousal, and mood alterations. The Abbreviated PCL-5 is validated across diverse populations and is widely used in both military and civilian trauma research. It is recommended by the National Center for PTSD.
Symptom Burden Questionnaire - Long COVID (SBQ-LC)
时间窗: Week 0, Week 4 and Week 8
The SBQ-LC measures the intensity and impact of Long COVID symptoms, offering key insight into the ongoing symptom burden experienced. The SBQ-LC demonstrates strong psychometric properties with high internal consistency across subscales and good convergent validity with established measures of symptom severity and functional impairment. It has been validated across diverse Long COVID populations in multiple clinical settings.
Body Perception Questionnaire (BPQ)
时间窗: Week 0, Week 4 and Week 8
The BPQ assesses self-reported autonomic reactivity and has been used in a range of international neural, behavioral, and clinical studies and translated into several languages. It has been corroborated with sensor-based measures of autonomic function.
Benefits Scale
时间窗: Weekly
The Benefits Scale assesses biobehavioral state, including the ability to quiet thoughts, awareness of bodily rhythms, breathing, muscular relaxation, physical pain levels, and emotional states such as peacefulness, relaxation, anxiety, irritability, feeling overwhelmed, worry about the future, and vulnerability.
Resting Heart Rate
时间窗: Weekly
Monitoring resting heart rate will allow us to assess whether SAT and Truvaga Electrical Vagus Nerve Stimulator are effective in lowering the elevated resting heart rate often observed in Long COVID patients via parasympathetic stimulation.
Steps
时间窗: Weekly
Monitoring steps will allow us to assess whether SAT and Truvaga Electrical Vagus Nerve Stimulator are associated with an increase in average daily steps, which may indicate enhanced functional capacity or reduced fatigue.
Active Zone Minutes
时间窗: Weekly
Active Zone Minutes are a measure of time spent in elevated heart rate zones, including Fat Burn, Cardio, and Peak zones.
Patient Health Questionnaire-8 (PHQ-8)
时间窗: Week 0, Week 4 and Week 8
The PHQ-8 is a gold-standard screening tool for major depressive disorder, endorsed by the CDC and WHO, with strong criterion validity and sensitivity to clinical change.
Generalized Anxiety Disorder-7 (GAD-7)
时间窗: Week 0, Week 4 and Week 8
The GAD-7 captures both somatic and cognitive components of generalized anxiety. Extensively used in both clinical and epidemiological contexts, the GAD-7 shows excellent internal consistency (α \> 0.90) and convergent validity with clinician-administered diagnostic tools.
PTSD Checklist for DSM-5 Short Form (Abbreviated PCL-5)
时间窗: Week 0, Week 4 and Week 8
The Abbreviated PCL-5 captures re-experiencing, avoidance, hyperarousal, and mood alterations. The Abbreviated PCL-5 is validated across diverse populations and is widely used in both military and civilian trauma research. It is recommended by the National Center for PTSD.
Symptom Burden Questionnaire - Long COVID (SBQ-LC)
时间窗: Week 0, Week 4 and Week 8
The SBQ-LC measures the intensity and impact of Long COVID symptoms, offering key insight into the ongoing symptom burden experienced. The SBQ-LC demonstrates strong psychometric properties with high internal consistency across subscales and good convergent validity with established measures of symptom severity and functional impairment. It has been validated across diverse Long COVID populations in multiple clinical settings.
Body Perception Questionnaire (BPQ)
时间窗: Week 0, Week 4 and Week 8
The BPQ assesses self-reported autonomic reactivity and has been used in a range of international neural, behavioral, and clinical studies and translated into several languages. It has been corroborated with sensor-based measures of autonomic function.
Benefits Scale
时间窗: Weekly
The Benefits Scale assesses biobehavioral state, including the ability to quiet thoughts, awareness of bodily rhythms, breathing, muscular relaxation, physical pain levels, and emotional states such as peacefulness, relaxation, anxiety, irritability, feeling overwhelmed, worry about the future, and vulnerability.
Sleep Metrics
时间窗: Weekly
The investigators will use the sleep categories of accumulated minutes of deep sleep, REM sleep, light sleep, and wakefulness during the night to provide us with sleep architecture.
Resting Heart Rate
时间窗: Weekly
Monitoring resting heart rate will allow us to assess whether SAT and Truvaga Electrical Vagus Nerve Stimulator are effective in lowering the elevated resting heart rate often observed in Long COVID patients via parasympathetic stimulation.
Steps
时间窗: Weekly
Monitoring steps will allow us to assess whether SAT and Truvaga Electrical Vagus Nerve Stimulator are associated with an increase in average daily steps, which may indicate enhanced functional capacity or reduced fatigue.
Breathing Rate
时间窗: Weekly
This measurement captures a user's average breaths per minute during sleep.
Heart Rate Variability (HRV)
时间窗: Weekly
Heart rate variability (HRV) is a widely recognized biomarker for autonomic nervous system regulation. Long COVID is commonly associated with reduced HRV, reflecting autonomic nervous system dysregulation. Lower HRV in these patients has been linked to greater symptom burden.
Cardio Score (VO2 Max)
时间窗: Weekly
Tracking changes in estimated aerobic capacity can help evaluate whether approaches are improving cardiovascular function and exercise tolerance over time.
SpO2
时间窗: Weekly
SpO2 measures blood oxygen saturation levels, indicating how well oxygen is being transported throughout the body.
次要结局
未报告次要终点