Transauricular Neurostimulation for Irritable Bowel Syndrome
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Treatment Adherence Rate
研究概览
简要总结
This single-site, open-label pilot study will evaluate transcutaneous auricular neurostimulation using the Sparrow Link device as a treatment for adolescents aged 12 to 18 years with abdominal pain related to disorders of gut-brain interaction. Up to 30 participants will be enrolled, with a goal of 20 completing the study. Participants will use the device for at least one hour daily for 4 weeks and complete questionnaires through week 8. The study will assess adherence, retention, safety, and preliminary changes in abdominal pain, bowel symptoms, quality of life, and anxiety.
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
- 12 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 12-18 years.
- •Clinical diagnosis of an abdominal pain-related disorder of gut-brain interaction (DGBI) meeting Rome IV criteria.
- •Average abdominal pain intensity ≥3 on a 0-10 scale and pain on at least 2 days per week.
- •Proper fit of the Sparrow earpiece on the left ear, as determined by study personnel.
排除标准
- •Medical or psychiatric condition that contraindicates transauricular neurostimulation or creates a safety risk.
- •Abnormal ear anatomy preventing earpiece placement.
- •Developmental delay.
- •Implanted electronic device or hearing aid.
- •Participation in another interventional trial.
- •Pregnancy
- •Unable to communicate in English.
- •Prisoner.
- •Change in medications used to treat abdominal pain or gastrointestinal symptoms within 2 weeks before enrollment. Participants must be on stable doses for at least 2 weeks before enrollment.
研究组 & 干预措施
Transauricular neurostimulation
All participants receive active transcutaneous auricular neurostimulation using the Sparrow Link device for at least one hour daily for 4 weeks, with follow-up assessments through week 8.
干预措施: Transcutaneous auricular neurostimulation (Device)
结局指标
主要结局
Treatment Adherence Rate
时间窗: During the 4-week intervention period.
Description: Percentage of the 28 prescribed intervention days with recorded Sparrow Link device use, calculated from device logs.
Study completion rate
时间窗: From enrollment through week 8.
Percentage of enrolled participants who complete the 8-week study.
次要结局
- Change in Pain Frequency, Severity, and Duration(Baseline through week 8)
- Change in Pediatric Quality of Life(Baseline through week 8.)
- Change in Anxiety(Baseline through week 8.)
- Change in Bristol Stool Form Scale(Baseline through week 8.)
研究者
Peter Lu
Professor of Pediatrics
Nationwide Children's Hospital