Study of the Nocebo Effect in Patients With Obstructive Sleep Apnea Syndrome and Treatment With Continuous Positive Airway Pressure
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
- 否
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
Mireia Dalmases
Principal Investigator
Hospital Clinic of Barcelona
