NCT06489717已完成不适用
Comparative Study of Sleep Disordered Breathing (SDB) in Patients With High Altitude Pulmonary Hypertension Permanently Residing Above 2500 Meters When Assessed Near Resident High Altitude (HA) at 3200 m vs. at Low Altitude (LA) 760 m
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Mean nocturnal SpO2 during the first night at LA vs HA
研究概览
简要总结
To study the effect of relocation from 3200m (Aksay) to 760m (Bishkek) in highlanders with High Altitude Pulmonary Hypertension (HAPH) who permanently live >2500m on sleep disordered breathing
详细描述
This research in highlanders with HAPH diagnosed by echocardiography and defined by a RV/RA >30 mmHg who permanently live at HA >2500 m will have nocturnal respiratory sleep studies near their living altitude in Aksay at 3200 m and on night 1 and 6 at 760m after relocation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Permanently living >2500 m
- •HAPH diagnosed with a minimum RV/RA of 30 mmHg assessed by echocardiography at an altitude of 3200 m
- •Written informed consent
排除标准
- •Highlanders who cannot follow the study investigations,
- •Patients with moderate to severe concomitant lung disease (FEV1<70% or forced vital capacity <70%), severe parenchymal lung disease, heavy smoking >20 cigarettes/day or >20 pack-years.
- •Coexistent unstable systemic hypertension or coronary artery disease that required adjustment of medication within the last 2 months
- •Regular use of medication that affects control of breathing (benzodiazepines, opioids, acetazolamide)
结局指标
主要结局
Mean nocturnal SpO2 during the first night at LA vs HA
时间窗: night 1 at 760 m compared to 3200 m.
Change in mean nocturnal SpO2 (%) between LA (760 m) vs HA (3200 m)
次要结局
- AHI at LA vs HA(night 1 and night 6 at 760 m compared to 3200 m.)
- Time spent with periodic breathing at LA vs. HA(night 1 and night 6 at 760 m compared to 3200 m.)
- Heart rate variability at LA vs. HA(night 1 and night 6 at 760 m compared to 3200 m.)
- pulse transit time drops at LA vs. HA(night 1 and night 6 at 760 m compared to 3200 m.)
- Time spent with SpO2<90% at LA vs HA(night 1 and night 6 at 760 m compared to 3200 m.)
- ODI at LA vs. HA(night 1 and night 6 at 760 m compared to 3200 m.)
- Mean nocturnal SpO2 during the sixth night at LA vs HA(night 6 at 760 m compared to 3200 m.)
- ECG markers of repolarization at LA vs. HA(night 1 and night 6 at 760 m compared to 3200 m.)
研究者
研究点 (1)
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