Cost-effectiveness Study of an Integrated Tertiary Hospital-primary Care Lifestyle Change Program for the Treatment of Obstructive Sleep Apnea Syndrome and Obesity
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 90
- 试验地点
- 2
- 主要终点
- Number of patients with Apnea Hypopnea Index under 30 per hour after receiving the program. Home Respiratory Polygraphy.
研究概览
简要总结
Obesity is the main risk factor for Obstructive Sleep Apnea (OSA). Nasal CPAP is the standard treatment for OSA, but since weight-loss programs are not usually offered to OSA patients, the root causes of their illness and its comorbidities are not treated. There is some evidence regarding improvements in OSA after weight reduction but whether weight reduction programs are cost-efficient has not as yet been addressed. OBJECTIVE: To determine whether an intensive weight-loss program, carried out in a project combining hospital and primary care levels, is cost-effective in the medium and long term for the treatment of obese patients with severe OSA undergoing CPAP treatment. More concretely, our objective is to demonstrate whether this program achieves sufficient improvement in OSA to allow a reduction <30/h in the apnea-hypopnea index in at least 25%, improving their metabolic profile and central obesity. METHOD: A prospective, randomized, controlled study. Control group: standard dietary recommendations.
Intervention group: 0-3 months very low calorie diet, 15 days substituting three meals for low calorie shakes, from 15 to 120 days substituting 1 meal and from 120 days to 12 months on a low calorie diet while starting a progressive exercise program. Recommendations for good sleep habits will be given. The program will be carried out through group and individual sessions with the hospital dietician. After 3 months: group sessions with a nurse in the basic area. Group sessions led by hospital dietician. From 3 to 12 months: group sessions led by primary care nurse. MEASUREMENTS: At the beginning, at 3 and at 12 months: two-night home respiratory polygraph, actigraphy, anthropometric and blood analysis data including metabolic syndrome and inflammatory markers, and health related quality of life questionnaires. Direct and indirect costs of treatments, outpatient's consultations, incomes, emergency visits and patients' travel costs to medical centers.
详细描述
HYPOTHESIS The implementation of an intensive weight loss program, initiated under the supervision of an expert nutritionist and continued under the supervision of a trained primary care nurse can help obese patients with severe obstructive sleep apnea (OSA) undergoing continuous positive airway pressure (CPAP) treatment to achieve significant weight loss and will result in a reduction in OSA severity in a significant percentage of patients leading to the possibility of their ceasing CPAP treatment.
The program will also improve the control of comorbidities, hypertension, diabetes and dyslipidemia and inflammation.
OBJECTIVES
Primary objective Assess whether a lifestyle change program, carried out in a combined and coordinated way with the hospital and primary care environments, can be cost-effective in the medium and long term for the treatment of OSA in obese patients with severe OSA who are already receiving CPAP treatment. In particular, to demonstrate that the program is able to achieve sufficient improvement in OSA to provide at least 25% of patients with a reduction of apnea hypopnea index (AIH <30/h).
Secondary objectives Assess whether a lifestyle change program in obese patients with OSA who are already receiving CPAP treatment can achieve lower blood pressure levels, improve blood lipids and glycemic control and reduce C reactive protein and central obesity.
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
- None
入排标准
- 年龄范围
- 25 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •diagnosed with severe OSA (apnea apnea hypopnea index (AHI)> 30 / h),
- •undergoing CPAP treatment for at least 6 months,
- •with a body mass index (BMI)> = 30 kg / m2 y = <40 kg / m2,
- •living in the area of the 5 participating primary care centers
排除标准
- •diseases that can limit the practice of exercise or adherence to diet,
- •severe cognitive or psychiatric disorders that prevent understanding of the program,
- •serious illnesses, severe cardiovascular disease with clinical instability during the month prior to inclusion,
- •prior bariatric surgery,
- •refusal of the patient to participate in the study and craniofacial malformations that prevent OSA improvement.
结局指标
主要结局
Number of patients with Apnea Hypopnea Index under 30 per hour after receiving the program. Home Respiratory Polygraphy.
时间窗: Baseline, at 3 months and 12 months
Asses whether a lifestyle change program can be effective in medium and long term for treatment of OSA in obese OSA patients who are already receiving CPAP treatment.
Cost-effectiveness ot an intensive weight loss programme
时间窗: Baseline, at 3 months and 12 months
Asses whether a lifestyle change program can be cost-effective in medium and long term for treatment of OSA in obese OSA patients who are already receiving CPAP treatment.
Improvement of apnea-hypopnea index/hour: Home Respiratory polygraphy (Type 3)
时间窗: Baseline, at 3 months and 12 months
apnea-hypopnea index/hour: Home respiratory polygraphy (Type 3)
Direct and indirect costs
时间窗: Baseline and 12 months
All direct and indirect costs will be collected. Costs of CPAP and its fungibles, medical visits in primary care medicine and specialized medicine , hospital admissions and emergency consultations. Costs derived from sick leave. Costs derived from traffic and labor accidents. Costs of visits and tests carried out in the intervention. Cost derived of side effects from intervention. Patients Travel costs at the hospital and the primary medicine center. Costs derived from the use of sports equipment. Costs derived from side effects of the intervention. Mediation costs collecting changes during the protocol.
次要结局
- weight(Baseline, at 3 months and 12 months)
- Waist circumference(Baseline, at 3 months and 12 months)
- Neck Circumference(Baseline, at 3 months and 12 months)
- Body fat Composition by bioimpedance analysis(Baseline, at 3 months and 12 months)
- Measurement of health-related quality of life(Baseline, at 3 months and 12 months)
- Cardiovascular risk factors and comorbidity(Baseline, at 3 months and 12 months)
- Testing for Ketones(from baseline to 3 month.)
- Physical activity diary(Baseline, at 3 months and 12 months)
- Triglycerides (millimol/litter)(Baseline, at 3 months and 12 months)
- Total Cholesterol(Baseline, at 3 months and 12 months)
- Blood pressure(Baseline, at 3 months and 12 months)
- Height(Baseline)
- Body Mass Index(Baseline, at 3 months and 12 months)
- Actigraphy(Baseline, at 3 months and 12 months)
- Glycosylated Hemoglobin(Baseline, at 3 months and 12 months)
- Fasting glucose(Baseline, at 3 months and 12 months)
- Low Density lipoprotein (LDL) cholesterol (millimole/litter)(Baseline, at 3 months and 12 months)
- Very Low lipoprotein (VLDL) cholesterol (millimole/litter)(Baseline, at 3 months and 12 months)
- High Density lipoprotein (HLDL) cholesterol (millimole/litter)(Baseline, at 3 months and 12 months)
- C-reactive protein (milligram/liter)(Baseline, at 3 months and 12 months)
- Aspartate aminotransferase (microgram/liter)(Baseline, at 3 months and 12 months)
- Alanine aminotransferase (microgram/liter)(Baseline, at 3 months and 12 months)
研究者
Neus Salord Oleo
Medical Doctor, PH D
Hospital Universitari de Bellvitge