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临床试验/NCT01161381
NCT01161381已完成不适用

Evaluation Of Patients With Suspected Obstructive Sleep Apnea - Hypopnea Syndrome Using Two Models Based on Nonlinear Analysis Of Respiratory Signals

Aristotle University Of Thessaloniki1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2005年11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
100
试验地点
1
主要终点
nonlinear dynamics of respiratory signals

研究概览

简要总结

Objective: Obstructive Sleep Apnea-Hypopnea Syndrome (OSAHS) is a common sleep disorder requiring the time and money consuming full polysomnography to be diagnosed. Alternative methods for initial evaluation are sought. The investigators aim was the prediction of Apnea-Hypopnea Index (AHI) in patients suspected to suffer from OSAHS using two models based on nonlinear analysis of three biosignals during sleep.

Methods: One hundred patients referred to a Sleep Unit underwent full polysomnography. Three nonlinear indices (Largest Lyapunov Exponent, Detrended Fluctuation Analysis and Approximate Entropy) were extracted from three biosignals (airflow from a nasal cannula, thoracic movement and Oxygen saturation) providing input to a data mining application for the creation of predictive models for AHI.

详细描述

Patients referred to the Sleep Unit of a tertiary hospital in northern Greece during the years 2005-2008 and who accepted to sign the informed consent form were included in the study. One out of every five consecutive patients was selected in order to ensure randomization. The study protocol was approved by the ethics committee of the hospital. All the subjects reported symptoms consistent with OSAHS and had no significant comorbidities. The presence of dementia, neuromuscular disorders, overlap syndrome or severe cardiac problems was an exclusion criterion for the participants. The subjects underwent full overnight attended polysomnography (Somnologica 7000, Flaga; Iceland) according to standard criteria including respiratory recordings of thoracic and abdominal movements, nasal flow by pressure cannula, snoring, and arterial oxygen saturation using pulse oximetry. Apnea and hypopnea were defined in accordance with standard used criteria. All the recordings were manually scored by the same experienced medical doctor.

Three nonlinear indices (Largest Lyapunov Exponent-LLE, Detrended Fluctuation Analysis-DFA and Approximate Entropy-APEN) were extracted from two respiratory signals (nasal cannula flow-F and thoracic belt movement-T). The oxygen saturation signal (SpO2) from pulse oximetry was also selected. The above signals had a mean duration of 317.5 minutes and were first exported in European Data Format (EDF) to be further processed with the use of signal processing software (Matlab by Mathworks Inc.) in personal computers. The LLE calculation required the use of a command line application by Rosenstein et al as well as a spreadsheet program (Microsoft Excel).

The basic statistical analysis was performed with the use of SPSS for Windows, Version 15.0 (SPSS Inc, Chicago, Illinois). Correlations between the studied or derived parameters were explored with the Pearson's correlation test and differences in the mean observed values between the various OSAHS severity groups were analyzed using the Student's t-test. The statistical significance level was set at p<0.05. The predictive model was created by utilizing the linear regression tool.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Prospective

入排标准

年龄范围
18 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • symptoms compatible with OSAHS
  • voluntary participation

排除标准

  • presence of dementia
  • neuromuscular disorders
  • overlap syndrome
  • severe cardiac problems

结局指标

主要结局

nonlinear dynamics of respiratory signals

时间窗: One night

calculation of nonlinear parameters (DFA, LLE, APEN) from recorded respiratory biosignals (nasal airflow, thoracic movement and SpO2) during sleep.

次要结局

未报告次要终点

研究者

申办方类型
Other

研究点 (1)

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