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临床试验/NCT05284045
NCT05284045已完成不适用

Study of the Nocebo Effect in Patients With Obstructive Sleep Apnea Syndrome and Treatment With Continuous Positive Airway Pressure

Hospital Clinic of Barcelona2 个研究点 分布在 1 个国家目标入组 97 人开始时间: 2022年3月8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
97
试验地点
2
主要终点
Number of side effects

研究概览

简要总结

This study is aimed to evaluate whether the information provided by health care professionals in the visits previous to start with CPAP treatment may influence the number of reported adverse effects and compliance in patients with obstructive sleep apnea (OSA) in treatment with CPAP.

详细描述

Background: The presence of side effects in the first few weeks of treatment with CPAP is common. However, it has never been evaluated whether side effects could be related to the presence of the nocebo effect in this population.

Main objective: To assess whether the information provided by health care professionals may influence the number of reported adverse events and compliance in patients with obstructive sleep apnea (OSA) in treatment with CPAP.

Methodology: Unicentric randomized clinical trial that will include 80 patients over 18 years of age with a recent diagnosis of OSA and indication for treatment with CPAP. Participants will be recruited consecutively and will be randomly assigned in a 1: 1 ratio to receive usual information or more detailed information in possible adverse effects of treatment during the CPAP adaptation visit. Follow-up will be performed at 1 month and 3 months after starting CPAP treatment. Side effects and treatment compliance in each of the groups will be blindly assessed. Descriptive statistics and differences in the number of side effects and hours of compliance between the two groups will be performed.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
盲法
Double (Participant, Outcomes Assessor)

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

  • Patients diagnosed with OSA with indication for CPAP treatment
  • To be over 18 years old
  • Sign informed consent for study participation.

排除标准

  • Patients previously treated with CPAP.
  • Patients with other previous treatments for OSA (surgery, mandibular advancement device, etc.)
  • Presence of any other previously diagnosed sleep disorder
  • Patients with> 50% central sleep apnea or Cheyne-Stokes respiration
  • Diagnosis of a mental or physical condition that makes difficult to complete questionnaires

结局指标

主要结局

Number of side effects

时间窗: at 1 month

Evaluate the number of side effects reported in both arms

次要结局

  • Hours of CPAP use(at 3 month)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Mireia Dalmases

Principal Investigator

Hospital Clinic of Barcelona

研究点 (2)

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