Interdisciplinary Weight Loss and Lifestyle Intervention for Obstructive Sleep Apnea in Women: The INTERAPNEA-Women Clinical Trial
试验速览
- 阶段
- 不适用
- 入组人数
- 180
- 主要终点
- Apnoea-hypopnoea index (AHI)
研究概览
简要总结
Obesity is a major risk factor for obstructive sleep apnoea (OSA), the most common sleep-disordered breathing related to neurocognitive and metabolic syndromes, type II diabetes, and cardiovascular diseases. Although strongly recommended for this condition, there are no studies on the effectiveness of an interdisciplinary weight loss and lifestyle intervention including nutrition, exercise, sleep hygiene, and smoking and alcohol cessation in women. INTERAPNEA-Women is a randomized controlled trial with a two-arm parallel design aimed at determining the effects of an interdisciplinary tailored weight loss and lifestyle intervention on OSA outcomes. The study will include 180 females aged 18-65 with a body mass index of ≥25 kg/m2 and severe to moderate OSA randomly assigned to usual care (i.e., continuous positive airway pressure), or interdisciplinary weight loss and lifestyle intervention combined with usual care. Outcomes will be measured at baseline, intervention end-point, and six-month post-intervention, including apnoea-hypopnoea index (primary outcome), other neurophysical and cardiorespiratory polysomnographic outcomes, sleep quality, daily functioning and mood, body weight and composition, physical fitness, blood biomarkers, and health-related quality of life. INTERAPNEA may serve to establish a cost-effective treatment not only for the improvement of OSA and its vast and severe comorbidities, but also for a potential remission of this condition.
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
- Female
- 接受健康志愿者
- 否
入选标准
- •Previous clinical diagnosis of moderate/severe OSA (AHI > 15)
- •Female 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.
研究组 & 干预措施
Usual Care
Participants from the usual care group will not receive any type of intervention apart from the usual care (CPAP).
Lifestyle Intervention
Participants from this group will receive a interdisciplinary intervention addressing weight loss and lifestyle change including nutritional behavior change, aerobic exercise, sleep hygiene, and alcohol and tobacco cessation combined with usual care (i.e., CPAP)
干预措施: Weight loss and lifestyle intervention (Behavioral)
结局指标
主要结局
Apnoea-hypopnoea index (AHI)
时间窗: Post-intervention (2 months)
Change in apnea (airflow reduction greater than or equal to 90%) and hypopnea (airflow reduction greater than or equal to 30%) episodes per hour of sleep measured by a respiratory polygraphy, from baseline (week 0) to post-intervention (2 months)
次要结局
- Light sleep (N1 and N2 stages)(Post-intervention (2 months))
- Body weight (kg)(Post-intervention (2 months))
- Chest circumference (cm)(Post-intervention (2 months))
- Plasma glucose (mg/dL)(Post-intervention (2 months))
- Sleep efficiency(Post-intervention (2 months))
- Deep sleep (N3 stage)(Post-intervention (2 months))
- Excessive daytime sleepiness (EDS)(Post-intervention (2 months))
- Sleep Quality(Post-intervention (2 months))
- Visceral adipose tisue (g)(Post-intervention (2 months))
- Waist circumference (cm)(Post-intervention (2 months))
- Oxygen saturation (SaO2) nadir(Post-intervention (2 months))
- Fat mass (kg)(Post-intervention (2 months))
- Mean blood pressure (mm HG)(Post-intervention (2 months))
- Oxygen desaturation index (ODI)(Post-intervention (2 months))
- Oxygen saturation (SaO2) mean(Post-intervention (2 months))
- Rapid eye movement (REM) sleep(Post-intervention (2 months))
- Wake After Sleep Onset (WASO)(Post-intervention (2 months))
- Neck circumference (cm)(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))
研究者
Almudena Carneiro Barrera
Principal Investigator
Universidad Loyola Andalucia