Efficacy of Oral Appliance for Upper Airway Resistance Syndrome: Randomized, Parallel, Placebo, Controlled Study
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Fatigue
研究概览
简要总结
Introduction: The Upper Airway Resistance Syndrome (UARS) is a sleep disorder characterized by airway resistance to breathing during sleep that leads to arousals and daytime sleepiness. There are few studies about UARS treatment and there is not any gold standard treatment for it yet.
Objective: Primary: To evaluate the efficacy of oral appliance on improving fatigue in patients with UARS. Secondary: Evaluate the effects of treatment with oral appliance (OA) in patients with UARS on sleepiness, mood, cognition, quality of life, metabolism and autonomic nervous system.
Methods: Subjects with UARS (Apnea/Hypopnea Index - AHI - ≤ 5 events per hour of sleep and Respiratory Disturbance Index - RDI - > 5 events per hour or more than 30% of total sleep time with inspiratory flow limitation and with excessive daytime somnolence and/or fatigue) of both genders, with body mass index (BMI) lower than 30Kg/m2 and between 25 to 50 years of age will be included. Subjects will be randomly distributed in OA group and placebo (without treatment). At baseline evaluation, 6 months and 1 year after subjects will be submitted to sleep questionnaires, physical exam, otolaryngological evaluation, baseline polysomnography, Epworth sleepiness scale, Multiple Sleep Latency Test, fatigue scale, neurocognitive testing, autonomic nervous system analysis (heart rate variability) and metabolic evaluation. Mean and standard deviation will be used for descriptive statistical analysis if normal distribution, and median and percentiles (25%, 75%) for variables not normally distributed. To compare treatment groups T test (parametric) and Mann Whitney (non parametric) will be used. For adjusted analysis, linear regression analysis will be used.
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
- Single (Participant)
入排标准
- 年龄范围
- 25 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Both genders
- •Body mass index (BMI) ≤ 30Kg/m2
- •Age from 25 to 50 years
- •Clinical and polysomnographic diagnosis of Upper Airway Resistance Syndrome: Apnea/Hypopnea Index (AIH) ≤ 5 events/hour and Respiratory Disturbance Index (RDI) > 5 events/hour or > 30% of total sleep time with inspiratory flow limitation with excessive daytime somnolence or fatigue
排除标准
- •Unsatisfactory dental condition or severe temporomandibular disfunction;
- •Nasal obstruction;
- •Alcohol abuse and excessive consumption of psychotropic drugs;
- •Clinical, neurological or psychiatric diseases not treated
- •Less than 6 hours of sleep
结局指标
主要结局
Fatigue
时间窗: From the baseline evaluation to one year after the treatment with oral appliance
Modified fatigue impact scale for Portuguese (MFIS- BR)
次要结局
- Subjective excessive daytime sleepiness(From the baseline evaluation to one year after the treatment with oral appliance)
- Objective excessive daytime sleepiness(From the baseline evaluation to one year after the treatment with oral appliance)
- Mood - Anxiety(From the baseline evaluation to one year after the treatment with oral appliance)
- Mood - Depression(From the baseline evaluation to one year after the treatment with oral appliance)
- Sustained attention(From the baseline evaluation to one year after the treatment with oral appliance)
- Cognition - Memory(From the baseline evaluation to one year after the treatment with oral appliance)
- Cognition - Learning strategies(From the baseline evaluation to one year after the treatment with oral appliance)
- Cognition - Immediate and late memories(From the baseline evaluation to one year after the treatment with oral appliance)
- Cognition - Processing speed ability(From the baseline evaluation to one year after the treatment with oral appliance)
- Cognition - Visual attention(From the baseline evaluation to one year after the treatment with oral appliance)
- Quality of sleep(From the baseline evaluation to one year after the treatment with oral appliance)
- Quality of life(From the baseline evaluation to one year after the treatment with oral appliance)
- Stress(From the baseline evaluation to one year after the treatment with oral appliance)
- Metabolism(From the baseline evaluation to one year after the treatment with oral appliance)
- Autonomic nervous system analysis(From the baseline evaluation to one year after the treatment with oral appliance)
研究者
Sonia Maria Guimaraes Pereira Togeiro Moura
Prof. Dra. Sonia Guimaraes Togeiro Moura
Associação Fundo de Incentivo à Pesquisa