Titration of Continuous Positive Airway Pressure Could Predict Success of Oral Appliance to Treat Sleep Apnea
Optimal Titration of Continuous Positive Airway Pressure Could Predict Success of Oral Appliance to Treat Obstructive Sleep Apnea Syndrome
Background: The oral appliances have been increasingly used in the treatment of primary snoring and in patients with mild obstructive sleep apnea syndrome besides being treatment options in adults with moderate to severe sleep apnea who did not accept or adapt to continuous positive airway pressure (CPAP). It is not well established yet in the literature, which patients with mild to moderate OSA will present a good response to treatment with oral appliances.
Objective: To determine a value of CPAP pressure that correlates with a favorable response to the use of oral appliance in patients with mild to moderate sleep apnea.
Patients and Methods: Two groups of 30 male patients (25-65 years, body mass index < 35 kg/m2) will be selected: the first group with an apnea-hypopnea index (AHI) between 5 and 15 events per hour of sleep and the second one with an AHI between 15 and 30 events per hour of sleep. Each patient will undergo three polysomnographic recordings (baseline, CPAP titration, after two months of treatment with oral appliance). Subjective (sleep disorders questionnaire, the Epworth Sleepiness Scale, and sleep diaries) and objective (polysomnography) parameters of sleep will be evaluated, besides the quality of life (SF-36), mood (POMS), and anthropometric measurements (neck circumference and craniofacial characteristic). Good response to treatment with the AIO will be considered as a 50% reduction in the baseline AHI index or AHI after treatment less than 5 events per hour of sleep.
研究概览
研究类型
注册 (预期的)
阶段
- 不适用
联系人和位置
学习地点
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SP
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São Paulo、SP、巴西、04023-062
- 招聘中
- Instituto do Sono/ Associação Fundo de Incentivo a Psicofarmacologia
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首席研究员：
- Lia Rita A Bittencourt, MD, PhD
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接触：
- Lia Rita A Bittencourt, MD,PhD
- 电话号码：115521490155
- 邮箱：lia@psicobio.epm.br
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接触：
- Lia Rita A Bittencourt, MD, PhD
- 电话号码：115521490155
- 邮箱：lia@psicobio.epm.br
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副研究员：
- Thays CA Cunha
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- Male subjects aged between 25 and 65 years old
- Epworth sleepiness Scale > 9
- Apnea-hypopnea index between 5 and 30
Exclusion Criteria:
- Presence of clinical disease (chronic obstructive pulmonary disease, asthma) and other sleep disorders.
- Presence of anatomical obstructive upper airway, tonsil grade III e IV, septal deviation and grade III that may affect the outcome of CPAP
- Loss of posterior dental support to undermine the retention of oral appliance
- Active of periodontal disease, compared Dental crow/dental root less than or equal to 1 (c/r ≤ 1) need primary dental care (cavities, root canal treatment or retreatment, dentures, i.e. outlying), open bite
- Protrusive displacement lass then five millimeters
- Limited mouth opening
- Alcoholism
- Use of sleep-inducing medications
- Habits or occupation that lead to sleep deprivation or alteration of the sleep-wake cycle
- Intolerance to CPAP
- Obesity grade II (moderate) or III (severe)
学习计划
研究是如何设计的？
设计细节
- 主要用途：治疗
- 介入模型：并行分配
- 屏蔽：单身的
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Objective sleep parameters
大体时间：two months after the baseline recording
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polysomnographic date of sleep stages percentages, sleep efficience, arousals, apnea-hypopnea index, oxyhemoglobin saturation
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two months after the baseline recording
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Subjective sleep parameters
大体时间：two months after the baseline recording
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Sleep disorders questionnaire, the Epworth Sleepiness Scale, and sleep diaries
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two months after the baseline recording
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|
Quality of life, mood, and anthropometric measurements
大体时间：two months after the baseline recording
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SF-36, POMS, neck circumference and craniofacial characteristic
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two months after the baseline recording
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合作者和调查者
调查人员
- 首席研究员：Lia Rita A Bittencourt, MD, PhD、Federal University of São Paulo
研究记录日期
研究主要日期
学习开始
初级完成 (预期的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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