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临床试验/NCT03003429
NCT03003429已完成不适用

Correlation Study Between Heart Rate Variability and Anxiety in Anorexia Nervosa

Hospices Civils de Lyon2 个研究点 分布在 1 个国家目标入组 13 人开始时间: 2017年3月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
13
试验地点
2
主要终点
Statistical correlation between autonomic dysfunction (measured by HRV) and anxiety (measured by questionnaire)

研究概览

简要总结

The heart rate variability (HRV) is a measure of the autonomic nervous system (ANS). In the model of anorexia nervosa, ANS is disturbed with mostly a predominance of activation of the parasympathetic nervous system and a decrease of the sympathetic system. Various explanations of this these dysfunctions are proposed in literature, mainly malnutrition, physical hyperactivity, anxiety, that are known characteristics of anorexia nervosa.

The primary aim of this study is to evaluate correlation between ANS dysfunction and anxiety in anorexia nervosa.

Other objectives of this study are firstly to evaluate correlation between ANS dysfunction and others parameters (weight, body mass index, depression, physical activity, purgative ou restrictive type, duration of disease, smoking) in anorexia nervosa and secondly to see if HRV is a predictive parameter of the evolution of anorexia nervosa.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Basic Science
盲法
None

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • Aged from 18 to 65 years
  • Criteria of anorexia nervosa (DSM V)
  • Body mass index (BMI) < 18 kg/m2
  • Written consent to participate in the study
  • Patient affiliated to a social security system

排除标准

  • Pacemaker or other implantable electronic device
  • Current comorbidity psychiatric disorder according to Axis I of DSM IV : severe depression (BDI > 8/13), substance use disorder .
  • Psychotropic drugs or ongoing steroid therapy ;
  • Pregnancy or breast-feeding ;
  • History or known cardiovascular disorder, including hypertension ( > 140/90 mmHg ) , heart failure, arrhythmia and conduction disorder .
  • Major protected by a legal protection
  • Patient involved in another research with an exclusion period ongoing at the run-in

结局指标

主要结局

Statistical correlation between autonomic dysfunction (measured by HRV) and anxiety (measured by questionnaire)

时间窗: at day 0

The composite measure consists of the following :- Time and spectral-domain measures of HRV measured by nocturn registration with heart rate monitor and polar RS800CX Time domain - NN (normal-to-normal R-R interval), HRV index (total number of all NN/ the height of the histogram of all NN), SDNN (standard deviation of the NN), RMSSD (the root mean square of differences of successive NN), NN50 (Number of pairs of adjacent NN intervals differing by more than 50 ms in the entire recording) and pNN50 (NN50/total number of all NN), SDANN (Standard deviation of the average of NN intervals in all 5-minute segments of a long recording), SDNNIDX (Mean of the standard deviation in all 5-minute segments of a long recording) Frequency domain - VLF Power (very low frequency; \<0.04 Hz), LF Power (low frequency; 0.04\~0.15 Hz), HF Power (high frequency; 0.15\~0.4 Hz), LF/HF ratio value - State-Trait Anxiety Inventory: version Y (STAI- form Y) - Morning blood cortisol level and serum prealbumin lev

次要结局

  • Statistical correlation between autonomic dysfunction (measured by HRV) and measures of Beck Depression inventory(at 6 months)
  • Statistical correlation between autonomic dysfunction (measured by HRV) and measures of International physical activity questionnaire(at day 0)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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