Changes in Body Fat and Morphologic Characteristics Associated With Obstructive Sleep Apnea (OSA) Resolution After Bariatric Surgery
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Comparison of (1) the relationship between waist circumference changes and resolution of obstructive sleep apnea and (2) the relationship between the changes in waist circumference and BMI
研究概览
简要总结
Prospective study with inclusion of bariatric surgery candidates with diagnosed Obstructive Sleep Apnea and requiring treatment with Continuous Positive Air Pressure, aiming to evaluate at 2-6-12 months after bariatric surgery whether the relationship between biometric changes (reduction in neck circumference, height, waist/hip ratio, and fat and lean mass) and the resolution of OSA is better than the relationship between these biometric changes and BMI reduction.
详细描述
Investigators are concerned about the high prevalence of Obstructive Sleep Apnoea syndrome (OSA) in the bariatric population. Postoperatively, there is a high rate of recovery from OSA. Indeed, investigators know from previous reports that weight loss is a very effective, but time consuming, strategy for treating OSA. Patients are therefore treated with CPAP (Continuous Positive Airway Pressure) while waiting for weight loss. In a recent meta-analysis, which focused on the effect of weight loss achieved through lifestyle interventions in 618 overweight and obese patients, the apnea-hypopnea index (AHI) decreased by an amount of 16/h for an average weight loss of 14 kg (1). However, the majority of patients are not able to maintain weight loss in the long term, and weight gain is associated with recurrence/aggravation of OSAS (2). Nowadays, bariatric surgery is a common strategy to achieve sustained and significant weight loss in obese patients. Sarkhosh et al. examined the impact of bariatric surgery (restrictive procedures, with a mild malabsorption component, or largely malabsorptive procedures) on sleep apnoea in 13,900 patients. Depending on the procedure, improvement or resolution of OSAS was achieved in 78-90% of patients (3).
Prospective longitudinal postoperative follow-up study : inclusion of patients who had scheduled bariatric surgery, diagnosed with OSA, AHI > 15 (polysomnography), treated with self-controlled CPAP (APAP), under remote monitoring;
Baseline measures:
- Anthropometric characteristics: body mass index (BMI), neck circumference, waist/hip ratio, fat mass + lean mass (bioelectrical impedance measurements),
- APAP treatment characteristics, mean APAP pressure, 95th percentile APAP pressure, APAP adherence.
Follow-up:
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Any informed person who is
- •eligible for bariatric surgery: with severe obesity (BMI≥35-40) or morbid obesity (BMI≥40), with co-morbidities, who have not lost enough weight with prior lifestyle adaptations (balanced diet, physical activity) AND
- •with diagnosed obstructive sleep apnoea (OSA) (AHI > 15/hr on polysomnography) AND
- •requiring treatment with Continuous Positive Air Pressure (CPAP)
排除标准
- •Cognitive impairment - language barrier
结局指标
主要结局
Comparison of (1) the relationship between waist circumference changes and resolution of obstructive sleep apnea and (2) the relationship between the changes in waist circumference and BMI
时间窗: 12 months
Comparison of (1) the correlation between waist circumference reduction and resolution of OAS (AHI\<10/hour on polysomnography) and (2) the correlation between waist circumference reduction and BMI reduction
次要结局
- Comparison of (1) the correlation between neck circumference reduction and OAS resolution and (2) the correlation between neck circumference reduction and BMI reduction(12 months)
- Comparison of (1) the correlation between hip circumference reduction and OAS resolution and (2) the correlation between hip circumference reduction and BMI reduction(12 months)
- Comparison of (1) the correlation between lean mass reduction and OAS resolution and (2) the correlation between lean mass reduction and BMI reduction(9 months)
研究者
Marie Bruyneel
Head of pneumology department
Centre Hospitalier Universitaire Saint Pierre