Effect of Addition of Changing Lifestyle to CPAP in OSA Males Who Suffer Metabolic Syndrome and Impotence
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- international index of erectile function (five-item Arabic version)
研究概览
简要总结
The problems like metabolic syndrome and sexual impotence in males with obstructive sleep apnea are common. continuous passive airway pressure (CPAP) is an authorized treatment for this type of apnea but still the recommendations of changing lifestyles are the suggested cornerstone therapies especially in obese males
详细描述
Forty males with metabolic syndrome, sexual impotence (erectile dysfunction), and obstructive sleep apnea will be randomized to control group (CPAP will be applied in this group that will contain 20 males, CPAP will be applied five days weekly during night-sleeping for 4 hours for 12 weeks ) and study 20-patient group (also CPAP will be applied with the same protocol of control group plus lifestyle changes that will contain 3-session per-week 40-minute treadmill exercising and low-caloric/dietary 12-week restriction)
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
- 40 Years 至 50 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •moderate and severe obstructive sleep apnea
- •erectile dysfunction (mild and moderate)
- •metabolic syndrome men
排除标准
- •cardiac patients
- •psychiatric men
- •autoimmune diseased men
- •renal diseased men
研究组 & 干预措施
study group
20 males with metabolic syndrome, sexual impotence (erectile dysfunction), and obstructive sleep apnea will be in this group (CPAP will be applied in this group that will contain 20 males, CPAP will be applied five days weekly during night-sleeping for 4 hours for 12 weeks plus lifestyle changes that will contain 3-session per-week 40-minute treadmill exercising and low-caloric/dietary 12-week restriction.
干预措施: lifestyle changing plus CPAP (Behavioral)
control group
20 males with metabolic syndrome, sexual impotence (erectile dysfunction), and obstructive sleep apnea will be included this control group. in this group CPAP will be applied five days weekly during night-sleeping for 4 hours for 12 weeks
干预措施: CPAP (Other)
结局指标
主要结局
international index of erectile function (five-item Arabic version)
时间窗: it will be measured after 12 weeks
a questionnaire that will assess erectile function
次要结局
- Epworth sleepiness scale(It will be measured after 12 weeks)
- triglycerides(It will be measured after 12 weeks)
- index of apnea and hypopnea(It will be measured after 12 weeks)
- ration of oxygen desaturation per hour(It will be measured after 12 weeks)
- body mass index(it will be measured after 12 weeks)
- neck circumference(It will be measured after 12 weeks)
- fasting glycemia(It will be measured after 12 weeks)
- high density lipoprotein(It will be measured after 12 weeks)
- systolic blood pressure(It will be measured after 12 weeks)
- diastolic blood pressure(It will be measured after 12 weeks)
- waist circumference(It will be measured after 12 weeks)
研究者
Ali Mohamed Ali ismail
lecturer of physical therapy for Cardiovascular, Respiratory disorder and Geriatrics, Faculty of Physical Therapy, Cairo University
Cairo University