Effect of Treating Sleep Apnea With Oral Appliances in the Elderly: ORACLE Study
试验速览
- 阶段
- 4 期
- 入组人数
- 500
- 试验地点
- 4
- 主要终点
- Arterial Blood Pressure Monitoring (ABPM)
研究概览
简要总结
Sleep apnea involves significant increases in disease and death, but its consequences in people over 65 years of age are incompletely recognized. Intraoral mandibular advancement appliances reduce the number of apneas and hypopneas. The investigators hypothesized that oral appliances provided to the elderly may prevent hypertension and other consequences of sleep apnea in large populations, at a favorable cost/benefit relationship for the public health system.
详细描述
Sleep disorders involve significant increases in morbidity and mortality, particularly in those over 60 years. Sleep apnea is the leading identifiable cause of hypertension, which is the main cause of cardiovascular disease. Some degree of sleep apnea is present in up to 95% of the elderly. Intraoral mandibular advancement appliances reduce the number of apneas and hypopneas.
We hypothesized that reducing the number of sleep apnea events through oral appliances is effective in preventing high blood pressure and other consequences of sleep apnea in the elderly in the public health system setting. In this superiority parallel, randomized, and double-blinded study we will compare the effect of an intraoral appliance with mandibular advancement to a placebo device without mandibular advancement in preventing high blood pressure and other consequences of sleep apnea in the elderly. The duration of intervention will be of 12 months, with assessments at three, six months, and 12 months.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Triple (Participant, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 65 Years 至 80 Years（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Mandibular advancement of at least 3 mm
- •Mouth opening of at least 30 mm
- •Sleep apnea with apnea-hypopnea index between 10 and 50 events/hour
- •Agree to participate in the study by signing the informed consent
排除标准
- •Already in treatment for sleep apnea
- •Self-reported severe or terminal Illness
- •Physical disability
- •Inability to communicate verbally
- •Dementia in the Mini-Mental State Examination
- •Plan to move to a different a city or to be institutionalized in the next year
- •Participation in another clinical trial
- •Less than eight teeth, periodontal disease, or TMJ problems
结局指标
主要结局
Arterial Blood Pressure Monitoring (ABPM)
时间窗: 12 months
24-h, diurnal, and sleep systolic and diastolic blood pressure. Systolic and diastolic dipping.
次要结局
- Composite measure of Metabolic Syndrome including Glucose, Cholesterol, Triglyceride, Blood pressure, and Waist circumference(12 months)
- Composite measure of Physical Ability(12 months)
- Composite measure of Pain(12 months)
- Quality of life measured by WHOQOL(12 months)
- Circadian rhythm(12 months)
- Composite measure of Cognitive function(12 months)
- Ophthalmological assessment(12 months)
- Heart rate variability(12 months)
- Cost-utility analysis measured by QALY(60 months)
- Change from Baseline Arterial Blood Pressure Monitoring (ABPM) at three months(3 months)
- Change from Baseline Arterial Blood Pressure Monitoring (ABPM) at six months(6 months)
研究者
Denis Martinez
MD, PhD
Hospital de Clinicas de Porto Alegre