Impact of Treatment With Mandibular Advancement Device (MAD) on Sleep Quality in Patients With Obstructive Sleep Apnea (OSA)
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- mandibular advancement device on sleep quality
研究概览
简要总结
Sleep is an important factor that influences long-term quality of life with known health consequences. Obstructive sleep apnea, the most prevalent disease that disturbs sleep, is considered a public health problem. Treatment with continuous positive airway pressure is cost effective and reverses the clinical consequences but there is a percentage of patients who do not tolerate it or leave it without treatment and with potential future health complications. Mandibular advancement device can be a valid and well tolerated alternative, it is known that it reduces apnea-hypopnea index, but its effect on the improvement of sleep quality is evaluated by polysomnography that interferes with the quality of sleep. There is an ambulatory monitoring device for sleep quality and circadian rhythms, which can register prolonged periods of time, under natural conditions and at a lower cost than a polysomnography. This pilot project assesses whether mandibular advancement device is an effective and well tolerated alternative in the treatment of obstructive sleep apnea to improve the quality of life and sleep in the medium and long term.
详细描述
Design: observational, unicentric prospective. 50 patients / year will be included, for 3 years. The care protocol (evaluation and follow-up) of the multidisciplinary sleep unit will be followed. Demographic and anthropometric data will be collected. The dental status of the temporo-mandibular joint will be assessed. Radiological records, home respiratory polygraphy, ambulatory monitoring device for 7 days , quality of life questionnaires before and after treatment.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of Obstructive Sleep Apnea Syndrome
- •opt for mandibular advancement device as 1st treatment alternative
- •opt for mandibular advancement device due to intolerance to continuous positive airway pressure
排除标准
- •Patient with orthodontics, malocclusion and periodontal or temporomandibular joint disease who, after assessment by dentistry contraindicates it.
- •Central Sleep apnea (more than 50% of central events in the baseline polygraph).
- •Under 18 years old.
- •Pregnancy
- •Comorbidities that can potentially alter sleep architecture.
- •Psychophysical inability to complete questionnaires.
- •Not obtaining informed consent.
结局指标
主要结局
mandibular advancement device on sleep quality
时间窗: 3 years
Tolerability and efficacy of treatment with a mandibular advancement device (MAD) on sleep quality in patients with Obstructive Sleep Apnea (OSA) measured by the ambulatory circadian monitoring device.
ambulatory circadian monitoring device
时间窗: 3 years
To evaluate improvement in sleep quality with mandibular advancement devices measured by fragmentation and stability of sleep by the circadian monitoring sensor.
home sleep apnea test
时间窗: 3 years
To evaluate the number of residual apneic breaths measured by home home sleep apnea test
次要结局
- questionnaire EuroQoL(3 years)
- questionnaire iPAQ(3 years)
- Obstructive sleep apnea severity(3 years)
- questionnaire SF-12(3 years)
研究者
Maria Fernanda Troncoso
Investigador principal
Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz