跳至主要内容
临床试验/NCT02913651
NCT02913651已完成不适用

Cardiovascular Variability and Heart Rate Arousal Response in Idiopathic Hypersomnia

Centre Hospitalier Universitaire de Saint Etienne1 个研究点 分布在 1 个国家目标入组 33 人开始时间: 2016年1月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
33
试验地点
1
主要终点
High Frequencies (HF)

研究概览

简要总结

Autonomic nervous system dysfunction has been described in narcolepsy with cataplexy affecting the sympathetic function. In this study the investigators analyzed whether altered diurnal and nocturnal cardiovascular control is present in idiopathic hypersomnia. Drug-free patients diagnosed with idiopathic hypersomnia and age-matched controls were included. Clinical data, 24-h polysomnography, heart rate variability and the heart rate response to spontaneous arousal are analyzed.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Idiopathic hypersomnia patients
  • idiopathic hypersomnia diagnosis
  • complaints of excessive daytime sleepiness for >1 year
  • a night-time length >10 h for 3 weeks before polysomnography as assessed by a sleep diary
  • Inclusion Criteria:
  • no idiopathic hypersomnia patients
  • no sleep complaints and excessive daytime sleepiness (Epworth sleep questionnaire score <10
  • Exclusion Criteria (both):
  • Narcolepsy-cataplexy
  • sleep irregularities and sleep deprivation symptoms
  • lack of neurological or psychiatric diseases
  • upper airway resistance syndrome
  • periodic limbs movements
  • cerebral lesion
  • medication or drinks affecting sleep and wake state

排除标准

  • 未提供

结局指标

主要结局

High Frequencies (HF)

时间窗: During the polysomnography (one night)

Nocturnal parasympathetic activity (HF parameter of heart rate variability analysis)

次要结局

  • Heart rate variability (HRV)(During the polysomnography (one night))
  • Apnea-Hypopnea Index (AIH)(During the polysomnography (one night))
  • Epworth Sleepiness Scale (ESS)(Before the polysomnography (one night))

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

Loading locations...

相似试验