Socio-Demographic - Dental & Respiratory Changes of Obstructive Sleep Apnea (OSA) Patients Treated With Mandibular Advancement Device (MAD) of Samples in Erbil City
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- measuring polysomnography record changes pre and post using appliance
研究概览
简要总结
The purpose of this study is to evaluate efficacy of mandibular advancement device (MAD). on treating obstructive sleep apneas, symptoms, Apnea/Hypopnea Index (QHI) and the Respiratory Arousal Index (AHI/REI) and peripheral capillary oxygen saturation (SpO2) Range, PULSE in patients with mild to moderate obstructive sleep apnea/hypopnea syndrome, and evaluating potential dental side effects
详细描述
The primary oral appliance (OA) used in obstructive sleep apnea (OSA) treatment is the mandibular advancement device (MAD). MADs may be either an over-the-counter stock device or customized for individual patients. MADs come in various designs and materials, but most comprise upper and lower splints mounted over the dentition as either a 1-piece monoblock or a 2-piece biblock Connectors or blocks relate the upper and lower splints in a biblock to protrude the mandible in a forward position during sleep.
Although the efficacy of oral appliances has been proved, the relationship to the nature of airway enlargement in patients with OSA has not yet been clearly demonstrated.
The aim of this study is therefore to evaluate the efficacy mandibular repositioning appliance reduces sleep apneas symptoms with mild to moderate obstructive sleep apnea . Secondary outcomes include the dental side effects of such appliance. At baseline and after 4 month's treatment, This study will be conducted to estimate frequency of OSA on population sample from Erbil study, in addition trying to evaluate the efficiency of MAD on some patients who are diagnosed with OSA.
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
- 25 Years 至 50 Years(Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •sample will be taken from Kurdish population in Erbil city.
- •Obstructive sleep apnea, apnea-hypopnea index of <30 with excessive daytime sleepiness
排除标准
- •People with problems in nasal part of airway.
- •People with cleft lip and palate
- •Patient who did tonsillectomy and / or other pharyngeal operations.
- •People who take any kind of sleep medication.
- •Temporomandibular Disorders.
- •People with periodontal disease.
- •Less than 8 teeth/ arch.
结局指标
主要结局
measuring polysomnography record changes pre and post using appliance
时间窗: 6 months
comparing polysomnography readings before and after using MAD to evaluate appliance efficacy
次要结局
- dental side effects(6 months)
研究者
Haval Jalal Rasheed
assistant lecturer
Hawler Medical University
