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临床试验/NCT02459548
NCT02459548
已完成
不适用

Validation of a Programme of Treatment and Follow-Up for Obstructive Sleep Apnea (OSA) Patients to be Applied by General Practitioners (GPs). Collaborative Network System Between GPs, CPAP Provider Enterprise and Sleep Specialists

Hospital Universitario Araba1 个研究点 分布在 1 个国家目标入组 220 人2014年2月
适应症OSA

概览

阶段
不适用
干预措施
未指定
疾病 / 适应症
OSA
发起方
Hospital Universitario Araba
入组人数
220
试验地点
1
主要终点
Number of hours of use per day of CPAP
状态
已完成
最后更新
7年前

概览

简要总结

The objective of the study is to compare the results of a follow-up and treatment coordinate and interactive program performed by the General Practitioners (GP) for Obstructive Sleep Apnea (OSA) patients treated with positive continuous pressure (CPAP) vs. usual control by sleep specialists from the sleep unit.

METHODOLOGY: DESIGN: Randomized comparative study. It will include patients with diagnosis of severe OSA that should start treatment with CPAP. Participating center is Hospital Universitario Araba in Vitoria-Gasteiz (Spain). These patients will be randomized to two monitoring groups : 1 monitoring in the sleep unit; 2: monitoring in primary care consultations by the General Practitioners (GP), once the OSA diagnosis has been made and it was indicated the treatment with CPAP.

Patients will be carried out in both groups the same follow-up visits in two study arms: basal, 1 month, 3 month and 6 months. PRIMARY OUTCOME: To compare the objective CPAP compliance treatment in the two study groups, so that use >= 4h/day is defined as good adherence to the treatment. SECONDARY OUTCOMES: 1)To evaluate the level of patient's satisfaction by visual-analogical scales and quality of life tests; 2) to establish the clinical improvement by somnolence and sleep scales; 3) To determine the numbers of CPAP complications, type, severity and duration; 4) To figure-out the level of take care of the CPAP machine, substitutions and complements, assistance and technical incidents; 5) Cost-effectiveness analysis.

注册库
clinicaltrials.gov
开始日期
2014年2月
结束日期
2016年5月
最后更新
7年前
研究类型
Interventional
研究设计
Parallel
性别
All

研究者

发起方
Hospital Universitario Araba
责任方
Principal Investigator
主要研究者

Joaquin Duran-Cantolla, MD

Joaquin Duran-Cantolla, MD Hospital Universitario Araba, Vitoria-Gasteiz (Spain)

Hospital Universitario Araba

入排标准

入选标准

  • Men and women over 18 years old.
  • Patients with OSA diagnosis performed in the sleep unit
  • Written informed consent signed.

排除标准

  • Previous CPAP treatment for OSA diagnosis
  • Psycho-physical inability to complete questionnaires
  • Presence of any previously diagnosed sleep disorders: narcolepsy, insomnia, chronic sleep deprivations, regular use of hypnotic or sedative medications nad restless leg syndrome
  • Patients with respiratory diseases (overlap syndrome, hypoventilation, restrictive diseases)
  • A medical history that may interfere with the study objectives or, in the opinion of the investigator, compromise the conclusions.

结局指标

主要结局

Number of hours of use per day of CPAP

时间窗: Six month

Compare the objective CPAP compliance treatment in the two study groups.

次要结局

  • Patient satisfaction (visual-analogical scale)(Six month)
  • Adverse events (number of CPAP complications)(Six month)
  • Comorbidity index (Charlson index)(Six month)
  • Level of clinical improvement evaluated through the Epworth Sleep Scale(At baseline and at 6 month of follow-up)
  • Quality of life (EuroQOL test)(Baseline and at 6 month of follow up)
  • Blood pressure(Six month)
  • Cost-effectiveness analysis(Six month)

研究点 (1)

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