NCT04146857已完成不适用
Effects of Normobaric Hypoxia on Autonomic Activity During a Nap in Healthy Adults (NAPOXIA)
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 16
- 试验地点
- 2
- 主要终点
- Heart rate variability
研究概览
简要总结
Sleeping under hypoxic conditions can impair cognition and autonomic nervous activity. A short daytime nap can modify these changes. Here we propose a randomized, cross-over study to evaluate the heart rate variability during a 90 min nap in a normobaric hypoxic chamber. In addition, we will investigate sleep architecture, vigilance, attention and memory.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 25 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Men and women
- •Age 25-45 years
- •BMI 20 - 28 kg/m^2
排除标准
- •Severe, manifest illnesses in need of treatment
- •Postoperative phases
- •Acute and chronic infections
- •Sleep disorders such as sleep apnea, insomnia or somnolence
- •Altitude exposure (> 2500 m asl) within 6 months before enrollment
- •Regular migraines
- •Significant weight change within 1 month before enrollment
- •Inability to understand significance and scope of the study
- •Drug or alcohol abuse
结局指标
主要结局
Heart rate variability
时间窗: During 90 minutes nap under normoxic (20.9%) vs. 12.8% hypoxic condition
Mean RR interval measured by polysomnography (ms)
次要结局
- Wake After Sleep Onset (WASO)(During 90 minutes nap under normoxic (20.9%) vs. two hypoxic conditions (12.8 and 15%))
- Digit Span Task(After 90 minutes nap under normoxic (20.9%) vs. two hypoxic conditions (12.8 and 15%))
- Low Frequency / High Frequency Band(During 90 minutes nap under normoxic (20.9%) vs. two hypoxic conditions (12.8 and 15%))
- RR intervals longer than 50 ms(During 90 minutes nap under normoxic (20.9%) vs. two hypoxic conditions (12.8 and 15%))
- Psychomotor Vigilance Task Subscale 2(After 90 min nap under normoxic (20.9%) vs. two hypoxic conditions (12.8 and 15%))
- Color Stroope Task Subscale 4(After 90 minutes nap under normoxic (20.9%) vs. two hypoxic conditions (12.8 and 15%))
- Sleep Onset Latency (SOL)(During 90 minutes nap under normoxic (20.9%) vs. two hypoxic conditions (12.8 and 15%))
- Heart rate variability(During 90 minutes nap under normoxic (20.9%) vs. 15.0% hypoxic condition)
- Sleep Efficiency (SE)(During 90 minutes nap under normoxic (20.9%) vs. two hypoxic conditions (12.8 and 15%))
- Standard Deviation 1 / Standard Deviation 2(During 90 minutes nap under normoxic (20.9%) vs. two hypoxic conditions (12.8 and 15%))
- Skin Temperature(During 90 minutes nap under normoxic (20.9%) vs. two hypoxic conditions (12.8 and 15%))
- Color Stroope Task Subscale 1(After 90 minutes nap under normoxic (20.9%) vs. two hypoxic conditions (12.8 and 15%))
- Core Body Temperature(During 90 minutes nap under normoxic (20.9%) vs. two hypoxic conditions (12.8 and 15%))
- Psychomotor Vigilance Task Subscale 1(After 90 minutes nap under normoxic (20.9%) vs. two hypoxic conditions (12.8 and 15%))
- Color Stroope Task Subscale 2(After 90 minutes nap under normoxic (20.9%) vs. two hypoxic conditions (12.8 and 15%))
- Color Stroope Task Subscale 3(After 90 minutes nap under normoxic (20.9%) vs. two hypoxic conditions (12.8 and 15%))
- Color Stroope Task Subscale 5(After 90 minutes nap under normoxic (20.9%) vs. two hypoxic conditions (12.8 and 15%))
研究者
Anja Maehler
Principal Investigator
Charite University, Berlin, Germany
研究点 (2)
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