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临床试验/NCT03644121
NCT03644121已完成不适用

Adherence to Continuous Positive Airway Pressure in Patients With Obstructive Sleep Apnoea Syndrome. Ten Year Follow up

Maugeri Foundation1 个研究点 分布在 1 个国家目标入组 140 人开始时间: 2006年8月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
140
试验地点
1
主要终点
CPAP use

研究概览

简要总结

The management of OSA is aimed to improve symptoms and mitigate reduce other health consequences. Continuous Positive Airway Pressure (CPAP) is the recognized treatment for OSA, able to reverse the pathophysiology of OSA and improving sleep continuity, resulting in improvements in daytime sleepiness and quality of life (QoL). However, low adherence to this treatment reduces the potential to achieve these benefits. The aim of this real life retrospective observational study was to assess the adherence to CPAP at 12 month and 10 years. The investigators evaluated also predicitve factors of adherence.

详细描述

Methods The protocol was approved (2215 CE, June, 19, 2018) by the Ethical Committee of the Istituti Clinici Scientifici (ICS) Maugeri, Pavia, Italy. All patients at admission to the Scientific Institute of Tradate gave the informed consent to the scientific use of their data.

Study Participants This study was conducted on a database of patients' discharge records, available between August, 2006 and December, 2009.

Adaptation to CPAP: titration of CPAP was performed either by full-night manual titration according to the AASM Guidelines or by automatic titration with Auto-Set systems. Further 4 day-time hours of adaptation were performed along two days. Patients underwent also four face to face sessions with the respiratory therapist, for feed-back of adaptation, optimal comprehension of procedure of CPAP management. The presence of a caregiver (if any) was strongly suggested.

Statistical Analysis An ad hoc electronic form was created to collect all study variables. Qualitative variables were described with absolute and relative (percentages) frequencies, whereas quantitative variables were summarized with means (standard deviations) or medians (interquartile ranges) based on their normal distribution, respectively.

In-between comparison for qualitative and quantitative variables was performed with the chi-squared or Fisher exact test when appropriate, and Student t or Mann-Whitney test in case of parametric or non-parametric distribution, respectively. Comparison of the temporal variation of continuous variables for the same group was assessed with Anova or Friedman's test, depending on their normal distribution.

研究设计

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

入排标准

性别
All
接受健康志愿者

入选标准

  • diagnosis of OSA
  • admitted for adaptation to CPAP

排除标准

  • other sleep related diseases
  • concomitant lung or thoracic diseases (including chronic respiratory failure requiring long term oxygen therapy)
  • major comorbidities (e.g. psychiatric conditions, cancer, end-stage renal failure)
  • familiar conditions preventing long-term home CPAP
  • patients already treated with CPAP

结局指标

主要结局

CPAP use

时间窗: Every 12 month for 10 years.Scale from 0 to 8 hours/night. Values >4,5 hours/night are considered to be a better outcome

number of Night-time hours of use (device counter)

次要结局

  • Body weight(once a year for 10 years)
  • Reported patients' day-time sleepiness(once a year for 10 years)

研究者

发起方
Maugeri Foundation
申办方类型
Other
责任方
Principal Investigator
主要研究者

elisabetta zampogna

principal investigator

Maugeri Foundation

研究点 (1)

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