Upper Airway of Women With Obstructive Sleep Apnea Changes After Bariatric Surgery and a Possible Influence of Menopause
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 38
- 试验地点
- 1
- 主要终点
- Changes in volumes and areas of upper airway
研究概览
简要总结
Evaluation of upper airway with Magnetic Resonance and polysomnographic at the pre and post operative of 23 women having undergone bariatric surgery (with the Y-Roux technique) for treatment of obesity.
详细描述
The the present study aims at describing the modifications occurring in the upper airway (UA) and the impact of such modifications on the severity of obstructive sleep apnea after bariatric surgery in women who have obstructive sleep apnea (OSA). The hypothesis is that the massive weight loss after bariatric surgery on OSA women could modify the UA more intensely than previously reported by other therapies for weight loss and that the menopause status may influence the likely reshaping of UA after bariatric surgery.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •patients with a recommendation and considered apt for bariatric surgery by the multi-professional group
- •aged between 18 and 70
- •with a residual (after the 16-week period) BMI above 35 kg/m2
- •polysomnographic obstructive sleep apnea diagnosis: Apnea-Hypopnea Index (AHI) above 5 events per hour associated with a co-morbidity and/or complaints of snoring.
排除标准
- •patients with body weight above 180 kg - for the impossibility of having a magnetic resonance (MR)
- •carrying metal artifacts which contraindicate the performing of MR
- •patients with a history of pharyngeal or neoplasia in the head and neck region
- •patients affected by gross craniofacial deformities
- •pregnant women
- •previous UA surgery for OSA
- •patients undergoing any other treatment for OSA.
结局指标
主要结局
Changes in volumes and areas of upper airway
时间窗: 6 months
Changes through MRI of measures upper airway and volume of tissues, as the percent of fat tissue within (in millimeters and %)
Upper airway changes after surgical weight loss
时间窗: 6 months
Changes in weight (kilograms) measured before and six months after the bariatric surgery.
Obstructive sleep apnea parameters measured thought polysomnographic changes after weight loss
时间窗: 6 months
Comparison of pre and post polysomnographic indexes: (apnea hypopnea index (AHI), arousals index, AHI at rapid eye movement (REM) sleep, AHI at supine position)
Correlation between the changes on upper airway with the changes on obstructive sleep apnea
时间窗: 6 months
Pearson correlation between the changes occurred on upper airway measures and polysomnographic after the procedure
次要结局
- Evaluation if the menstrual status interfere on outcomes(6 months)
研究者
Michel Burihan Cahali
Postgraduate supervisor and collaborating professor of Otorhinolaryngology at FMUSP
University of Sao Paulo General Hospital