Anxiety and Depression In Patients With Obstructive Sleep Apnoea Before and After Continuous Positive Airway Pressure: the ADIPOSA Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Change in anxiety symptoms measured by State-Trait Anxiety Inventory (STAI)
研究概览
简要总结
Continuous positive airway pressure (CPAP) is the gold-standard treatment for obstructive sleep apnoea (OSA), the most common sleep-disordered breathing in the overall population. CPAP has shown to be effective in reducing apnoea-hypopnoea index (AHI) as well as other OSA polysomnographic outcomes. However, the effectiveness of this device on OSA daily functioning and mood disturbances outcomes still remains unclear. The ADIPOSA study is aimed at determining the effects of three-month CPAP use on anxiety-depression symptoms in patients with OSA. Participants will be adults previously diagnosed with OSA who will be allocated to a CPAP-treatment group. Outcomes will be measured at baseline and intervention end-point (three months) including daytime sleepiness, daily functioning and mood (anxiety and depression symptoms), AHI, other neurophysical and cardiorespiratory polysomnographic outcomes, and body weight. ADIPOSA may serve to establish the effectiveness of CPAP on daytime functioning and mood disturbances commonly found on patients with OSA and, in turn, on other OSA outcomes related to anxiety-depression symptoms.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •Previous clinical diagnosis of mild/moderate/severe OSA (AHI > 5) by a healthcare professional
- •Use of CPAP
- •Motivation to participate in the study
- •Willing to provide informed consent
排除标准
- •Presence of any other primary sleep disorder
- •Presence of any mental disorder (including depression, anxiety, and addiction to alcohol or other substances)
- •Presence of any other severe organic disease, except for those comorbid to OSA
结局指标
主要结局
Change in anxiety symptoms measured by State-Trait Anxiety Inventory (STAI)
时间窗: Three months
Changes in state anxiety and trait anxiety components measured by STAI questionnaire after three-month CPAP usage
Change in depression symptoms measured by Beck's Depression Inventory-Fast Screen (BDI-FS)
时间窗: Three months
Changes in depression symptoms measured by BDI-FS questionnaire after three-month CPAP usage
次要结局
- Change in body mass index (BMI)(Three months)
- Change in apnoea-hypopnoea index (AHI) from baseline to post-intervention(Three months)
- Change in oxygen desaturation index (ODI) from baseline to post-intervention.(Three months)
- Change in excessive daytime sleepiness (EDS) from baseline to post-intervention(Three months)
研究者
Almudena Carneiro Barrera
Teaching and research academic staff
Universidad de Granada