A Prospective Study to Investigate the Use of Actigraphy as a Novel, Reliable and Non-invasive Study Endpoint to Facilitate Pediatric Pulmonary Arterial Hypertension Trials and Drug Development for Children Ages 0-6 Years
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 43
- 试验地点
- 1
- 主要终点
- Number of skin irritation adverse events: Visit 1
研究概览
简要总结
This study plans to learn more about activity levels in children with pulmonary hypertension. Pulmonary hypertension is a condition where the pressure in the lungs is higher than normal. This can affect the person's heart. The purpose of this study is to see if measuring activity in children with pulmonary hypertension and comparing it to activity in children without pulmonary hypertension can give their doctor helpful information on how they are feeling and how their treatment is working.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- — 至 6 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Number of skin irritation adverse events: Visit 1
时间窗: Over 14 Days, reported at Day 15 post baseline (Visit 1)
Number of skin irritation adverse events: Visit 2
时间窗: Over 14 days, reported at about 6 months post-baseline (Visit 2)
Number of Participants Meeting Compliance threshold for wearing actigraphy devices: Visit 2
时间窗: Over 14 days, reported at about 6 months post-baseline (Visit 2)
Actigraphy device wear compliance threshold is a minimum of 4 hours per day, and 8 compliant days out of 14 days of wear time.
Number of Participants Meeting Compliance threshold for wearing actigraphy devices: Visit 1
时间窗: Over 14 Days, reported at Day 15 post baseline (Visit 1)
Actigraphy device wear compliance threshold is a minimum of 4 hours per day, and 8 compliant days out of 14 days of wear time.
次要结局
- Heart rate: Visit 1(Over 14 Days, reported at Day 15 post baseline (Visit 1))
- Heart rate: Visit 2(Over 14 days, reported at about 6 months post-baseline (Visit 2))
- Energy expenditure per day (kcal): Visit 1(Over 14 Days, reported at Day 15 post baseline (Visit 1))
- Steps per day: Visit 1(Over 14 Days, reported at Day 15 post baseline (Visit 1))
- Steps per day: Visit 2(Over 14 days, reported at about 6 months post-baseline (Visit 2))
- Miles per day: Visit 1(Over 14 Days, reported at Day 15 post baseline (Visit 1))
- Miles per day: Visit 2(Over 14 days, reported at about 6 months post-baseline (Visit 2))
- Energy expenditure per day (kcal): Visit 2(Over 14 days, reported at about 6 months post-baseline (Visit 2))
- Active minutes per day: Visit 2(Over 14 days, reported at about 6 months post-baseline (Visit 2))
- Count of Activity Bouts: Visit 1(Over 14 Days, reported at Day 15 post baseline (Visit 1))
- Activity Count: Visit 1(Over 14 Days, reported at Day 15 post baseline (Visit 1))
- Activity Count: Visit 2(Over 14 days, reported at about 6 months post-baseline (Visit 2))
- Active minutes per day: Visit 1(Over 14 Days, reported at Day 15 post baseline (Visit 1))
- Count of Activity Bouts: Visit 2(Over 14 days, reported at about 6 months post-baseline (Visit 2))
- Count of Sedentary Bouts: Visit 1(Over 14 Days, reported at Day 15 post baseline (Visit 1))
- Physical Activity intensity: Visit 1(Over 14 days, reported at about 6 months post-baseline (Visit 2))
- Number of PH Participants with Clinical Worsening (CW) Events(End of Study (Up to 12 months post baseline))
- Natriuretic Peptide Tests - BNP(End of Study (Up to 12 months post baseline))
- Count of Sedentary Bouts: Visit 2(Over 14 days, reported at about 6 months post-baseline (Visit 2))
- Resting oxygen saturation at Visit 2(About 6 months post baseline)
- Natriuretic Peptide Tests - NT-proBNP)(End of Study (Up to 12 months post baseline))
- Resting oxygen saturation at Baseline(Baseline)
- Number of PH Participants with Genetic Mutations or Positive Genetic tests(End of Study (Up to 12 months post baseline))