EndoBarrier Obstructive Sleep Apnoea Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 12
- 试验地点
- 2
- 主要终点
- Requirement for continuous positive airway pressure (CPAP) treatment will be assessed by sleep studies at screening and then every 3 months, up to 24 months
研究概览
简要总结
Obstructive sleep apnoea (OSA) is a common condition in which the upper airways (windpipe) collapse repeatedly during sleep, blocking the flow of air into the lungs. It is characterized by repetitive pauses in breathing during sleep, despite the effort to breathe, and is associated with a reduction in the amount of oxygen in the blood (oxygen saturation). People with OSA are at risk of heart disease, high blood pressure, stroke, depression, and premature death. OSA is usually treated using a continuous positive airway pressure (CPAP) machine. This involves the patient wearing a face mask during sleep which is connected to the machine which supplies a constant steam of air to help keep the airways open. This improves the symptoms and hopefully the long-term outlook, but it is an uncomfortable solution. OSA is associated with obesity and weight loss can improve or even cure it. Treatment with EndoBarrier (placement of a thin flexible tube that is placed inside your intestine creating a physical barrier between the intestinal wall and the food so less can be absorbed) can be associated with significant weight loss and can improve blood sugar control in patients with type 2 diabetes related to their weight (diabesity). This study aims to find out if EndoBarrier treatment can improve OSA in patients with diabesity to the extent that some patients no longer require their CPAP machine treatment.
详细描述
Once the participant has decided to take part in the study, they will be invited for signing a consent form and screening checks which will include medical history, examination, blood tests (approximately 10 ml) and sleep studies (at home without CPAP) on two occasions within one week to determine whether they are eligible for the study. If they fulfil all the criteria and once recruited into the study, they will be assessed for placement of EndoBarrier by gastroenterologists (tummy doctors) followed by its insertion in City Hospital as a day case procedure. There may be individual or group information sessions including the use of models and videos to describe insertion and removal of EndoBarrier devices. Potential participants will be offered the opportunity to ask questions. There will be trial assessment visits for every 3 months until one year after the insertion of EndoBarrier and then for every 3 months up to one year following its removal. During these visits, participants are assessed clinically and have blood tests (approximately 10 ml taken in a fasted state), sleep studies and quality of life questionnaires. EndoBarrier will be removed after 1 year, again, as a day case procedure.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Moderate OSA on CPAP fulfilling NICE criteria for CPAP(AHI between 15 and 29 with symptoms)
- •Prediabetes(HbA1c between 42 & 48 mmol/mol) or confirmed type 2 diabetes (HbA1C≥48mmol/mol)
- •Obesity BMI ≥30 and ≤45 Kg/m2
- •Age ≥ 18 years
- •Capable of giving informed consent
排除标准
- •Abnormal intestinal anatomy
- •Contraindication to oesophagogastroduoenoscopy
- •Previous bariatric surgery or bowel surgery
- •Active infection
- •Anticoagulation therapy
- •Coagulopathy INR >1.3
- •Estimated Glomerular Filtration Rate (eGFR)<30
- •Known portal hypertension
- •Uncontrolled cardiovascular disease
- •Lactating or pregnant females
- •Excess anaesthetic risk
- •Patients taking non-steroidal anti-inflammatory agents will need to discontinue these for the duration of Endobarrier implantation
- •Patients taking aspirin/clopidogrel with active ischaemic heart disease or cerebrovascular disease(secondary prevention)
结局指标
主要结局
Requirement for continuous positive airway pressure (CPAP) treatment will be assessed by sleep studies at screening and then every 3 months, up to 24 months
时间窗: Every 3 months, up to 24 months
Requirement for continuous positive airway pressure
次要结局
- Continuous positive airway pressure (CPAP) pressures are measured by sleep studies at screening, and then every 3 months, up to 24 months(Every 3 months, up to 24 months)
- Blood pressure is measured by checking blood pressure at sitting at screening, baseline, and then every 3 months, up to 24 months(Every 3 months, up to 24 months)
- Glycated haemoglobin measured by blood test (HbA1c) at screening, baseline, and then every 3 months, up to 24 months(Every 3 months, up to 24 months)
- Quality of life scores is measured by EQ-5D questionnaire at baseline and then at 6, 12 and 24 months(At baseline and then at 6, 12 and 24 months)
- Obstructive sleep apnoea (OSA) symptoms are measured by sleep studies at screening, and then every 3 months, up to 24 months(Every 3 months, up to 24 months)
- Fasting plasma glucose is measured by blood test(fasting plasma glucose) at baseline, and then at 12 and 24 months(At baseline, and then at 12 and 24 months)
- Composite scores of NAFLD severity derived from the blood measurements of Alanine Aminotransferase in U/L, Aspartate Aminotransferase in U/L, platelets in x10^9/L and serum albumin in g/L as well as age in years and BMI(At screening, baseline, and then every 3 months, up to 24 months)
- Circulating free testosterone, fasting insulin and C-Peptide are measured by blood tests at baseline, and then at 3, 12 and 24 months(At baseline, and then at 3, 12 and 24 months)
- Apnea-hypopnea index (AHI) is measured by sleep studies at screening and then every 3 months, up to 24 months(Every 3 months, up to 24 months)
- Weight and Body mass index (BMI) is measured by checking weight in kilograms as well as height (in metres) ( weight and height will be combined to report BMI in kg/m^2) at screening, baseline, and then every 3 months, up to 24 months(Every 3 months, up to 24 months)
- Diabetes treatment including need for insulin is measured at baseline, and then every 3 months, up to 24 months21 and 24 months(Every 3 months, up to 24 months)
研究者
Dr Bob Ryder
Doctor
Sandwell & West Birmingham Hospitals NHS Trust