Lifestyle Intervention for Obstructive Sleep Apnoea in Adults: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 89
- 试验地点
- 2
- 主要终点
- Change in apnoea-hypopnoea index (AHI) from baseline to post-intervention.
研究概览
简要总结
Obstructive sleep apnoea (OSA) is characterized by the presence in the polysomnogram test of more than five apnoea-hypopnoea episodes per hour of sleep (apnoea-hypopnoea index, AHI > 5), each episode lasting more than 10 seconds and being accompanied by oxygen desaturation or arousal. The prevalence of this syndrome is worryingly high (9% to 38%), affecting more men than women. OSA has an important negative impact on physical/psychological health and on these patient's quality of life. The gold-standard treatment for OSA is the continuous positive airway pressure (CPAP). However, CPAP compliance is really low, this device requiring a continuous chronic use in order to improve OSA and to avoid the relapse. Furthermore, it does not address OSA risk factors such as obesity and unhealthy lifestyle habits. Consequently, non-surgical and non-pharmacological interventions such as weight loss and lifestyle interventions are necessary and recommended by the American Academy of Sleep Medicine (AASM). The objective of this project, therefore, is the development and evaluation of a cognitive-behavioural treatment program for patients with moderate-severe OSA. The treatment will pursued weight loss through hypocaloric diet and moderate exercise, smoking and alcohol avoidance, and sleep hygiene. The efficacy of this treatment will be assessed in comparison with CPAP, in a short and medium term. This intervention could be considered a good alternative/combined management to the usual treatment of OSA (CPAP) once its efficacy to reduce and even cure OSA symptoms is demonstrated, especially if it is still effective in the long-term.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Previous clinical diagnosis of moderate/severe OSA (AHI > 15) by a healthcare professional.
- •Male patients aged between 18-65 years.
- •Body mass index > 25 kg/m
- •Use of CPAP
- •Motivation to participate in the study.
- •Signed informed consent form.
排除标准
- •Sleep disorder other than OSA
- •Clinically significant psychiatric, neurological, or medical disorders other than OSA
- •Use of prescription drugs or clinically significant drugs affecting sleep
结局指标
主要结局
Change in apnoea-hypopnoea index (AHI) from baseline to post-intervention.
时间窗: Post-intervention (2 months)
Change in apnoea (airflow reduction greater than or equal to 90%) and hypopnoea (airflow reduction greater than or equal to 30%) episodes per hour of sleep, from baseline to post-intervention.
次要结局
- Change in mean blood pressure (mm HG) from baseline to post-intervention(Post-intervention (2 months))
- Change in deep sleep (N3 stage) from baseline to post-intervention(Post-intervention (2 months))
- Change in apnoea-hypopnoea index (AHI) in NREM sleep from baseline to post-intervention.(Post-intervention (2 months))
- Change in body weight (kg) from baseline to post-intervention(Post-intervention (2 months))
- Change in light sleep (N1 and N2 stages) from baseline to post-intervention(Post-intervention (2 months))
- Change in oxygen desaturation index (ODI) from baseline to post-intervention.(Post-intervention (2 months))
- Change in oxygen saturation (SaO2) mean from baseline to post-intervention(Post-intervention (2 months))
- Change in oxygen saturation (SaO2) nadir from baseline to post-intervention(Post-intervention (2 months))
- Change in sleep efficiency from baseline to post-intervention(Post-intervention (2 months))
- Change in fat mass (kg) from baseline to post-intervention(Post-intervention (2 months))
- Change in plasma glucose (mg/dL) from baseline to post-intervention(Post-intervention (2 months))
- Change in total cholesterol (mg/dL) from baseline to post-intervention(Post-intervention (2 months))
- Change in total triglycerides (mg/dL) from baseline to post-intervention(Post-intervention (2 months))
- Change in rapid eye movement (REM) sleep from baseline to post-intervention(Post-intervention (2 months))
- Change in apnoea-hypopnoea index (AHI) in REM sleep from baseline to post-intervention.(Post-intervention (2 months))
- Change in excessive daytime sleepiness (EDS) from baseline to post-intervention(Post-intervention (2 months))
- Change in Pittsburgh Sleep Quality Index (PSQI) from baseline to post-intervention.(Post-intervention (2 months))
- Change in Wake After Sleep Onset (WASO) from baseline to post-intervention(Post-intervention (2 months))
研究者
Almudena Carneiro Barrera
Teaching and Research Academic Staff
Universidad de Granada