跳至主要内容
临床试验/NCT05621577
NCT05621577尚未招募不适用

Socio-Demographic - Dental & Respiratory Changes of Obstructive Sleep Apnea (OSA) Patients Treated With Mandibular Advancement Device (MAD) of Samples in Erbil City

Hawler Medical University2 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2023年2月5日最近更新:
适应症

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

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

申办方类型
Other
责任方
Principal Investigator
主要研究者

Haval Jalal Rasheed

assistant lecturer

Hawler Medical University

研究点 (2)

Loading locations...

相似试验

Obstructive Sleep Apnea Patients Treated With... | 临床试验