Quality of Life in Patients With Obstructive Sleep Apnea: The Role of CPAP Associated to Psychological Support
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 104
- 试验地点
- 2
- 主要终点
- The difference between the proportion of subjects with no alterations of mood, measured by means of the QD2A test, before and 12 weeks after the start of treatment, observed in the CPAP group plus psychological support and only CPAP treatment
研究概览
简要总结
Many researches have shown that patients with Obstructive Sleep Apnea (OSA) and often also the family members have a decreased quality of life, problems related to the sexual sphere, depressive disorders and anxiety problems. To date still remains controversial the relationship between OSA and quality of life, also the link between sleep apnea syndrome and depression is unclear.
In adult patients with OSA the treatment of choice is the application of a continuous positive airway pressure (CPAP: Continuous Positive Airway Pressure) at the opening of the airways. With the CPAP treatment the sleep normalizes and daytime sleepiness fades or disappears.
Many studies have shown that this treatment determines improvement of the medical and psychological status. However, the rate of non-adherence to treatment reported in the literature is about 46-83%, considering as adherence the use of CPAP for at least 4 hours per night. A recent study has shown that CPAP used as a single treatment in patients with OSA and depression, has reduced the depressive symptoms but in a significant percentage of patients (42%), the depressive symptoms remained unchanged or worsened. At the present time have not been published, to our knowledge, studies concerning the effectiveness of the combined treatment of CPAP and psychological support on the mood and on the quality of life OSA patients.
Therefore the aim of this study is to evaluate the effects of the combined treatment with CPAP and psychological intervention with cognitive behavioural therapy on the mood and on the quality of life of OSA patients.
详细描述
Primary endpoint The primary endpoint of the study is the evaluation of the mood tone, measured before and 12 weeks after the start of treatment through the administration of the13-item self-rated Pichot depression scale (QD2A). Each subject will be assigned to one of the following categories:"absence of alterations in mood" or "presence of mood disorders," according to the test result (score <7 or score ≥7).
The subjects in which, for whatever reason, the QD2A test after 12 weeks of treatment will not be available, will be considered failures, and will be assigned to the class "presence of mood disorders." Secondary endpoint Evaluation of adherence to CPAP treatment, considering as adherence the use of CPAP, during the observation period, for at least 4 hours per night.
After 12 weeks of treatment, each patient will be classified as "adherent" or "non-adherent" to the treatment itself. The subjects in whom, for whatever reason, after 12 weeks of treatment, the total number of hours of use of CPAP will not be available, will be assigned to the class of "non-adherent".
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •all patients with a known diagnosis of obstructive sleep apnea who need of treatment with CPAP
- •aged 18-70 years
- •presence of alteration of mood, identified by a score of ≥7 by means the QD2A test
- •written informed consent, signed and dated
排除标准
- •previous treatment for OSA
- •sleep disorders different from OSA
- •cognitive impairment diseases
- •severe psychiatric disorders
- •alcoholism or other abuses.
研究组 & 干预措施
Group A
Study Group: patients with OSA and depressive symptoms treated with CPAP and psychological support
干预措施: CPAP and Psychological support (Behavioral)
Group B
Control Group: patients with OSA and depressive symptoms treated with CPAP
结局指标
主要结局
The difference between the proportion of subjects with no alterations of mood, measured by means of the QD2A test, before and 12 weeks after the start of treatment, observed in the CPAP group plus psychological support and only CPAP treatment
时间窗: 3 months
次要结局
- The difference between the proportion of subjects adherent to CPAP treatment in both groups, considering as adherence the use of CPAP, during the observation period, for at least 4 hours per night.(3 months)
研究者
Corrado Antonio, M. D
Chief of Respiratory Intensive Care Unit, MD
Careggi Hospital