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临床试验/NCT00477009
NCT00477009已完成不适用

A Randomized Controlled Trial of Effects From a Mandibular Advancement Device in Patients With Obstructive Sleep Apnea and Snoring

Umeå University2 个研究点 分布在 1 个国家目标入组 96 人开始时间: 2007年5月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
96
试验地点
2
主要终点
Sleep apnea and sleep measured by polysomnography

研究概览

简要总结

The purpose of this study is to evaluate effects from a mandibular repositioning appliance on obstructive sleep apneas, symptoms, blood pressure and markers of stress, inflammation and cardiovascular health in patients with mild to moderate obstructive sleep apnea/hypopnea syndrome and in patients with symptomatic snoring.

详细描述

Mandibular repositioning appliances for the treatment of snoring and sleep apneas are increasingly used over the world, although the number of prescriptions of this therapy varies between countries. The appliance widens the upper airways during sleep in order to reduce sleep-disordered breathing. The device is easy to use and has become popular among patients. Despite this, the evidence for effects of this treatment is not very strong and based on only a few studies. The aim of this study is therefore to test the hypothesis that a mandibular repositioning appliance reduces sleep apneas, daytime sleepiness and other sleep apnea symptoms and increases the quality of life in sleepy patients with mild to moderate obstructive sleep apnea and in patients with symptomatic snoring. Secondary outcomes include effects on headaches, blood pressure and markers of stress, inflammation, cardiovascular health and oxidative stress. At baseline and after 4 month's treatment, the patients will respond to questionnaires about symptoms and quality of life. They will undergo measurements of sleepiness, sleep apneas and blood pressure as well as sampling of saliva, urine and blood. Factors that predict a successful treatment outcome will be analyzed in order to more exactly clarify the indications for this treatment modality in a group of patients who have been suggested to benefit from mandibular repositioning appliances according to previous studies and reviews.

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
Triple (Participant, Investigator, Outcomes Assessor)

入排标准

年龄范围
20 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Obstructive sleep apnea, apnea-hypopnea index of <30 with excessive daytime sleepiness
  • Snoring with excessive daytime sleepiness, apnea-hypopnea index of <5
  • Body mass index of <35

排除标准

  • Unable to give informed consent
  • Psychiatric disorders including dementia that may interfere with the study protocol
  • Other concomitant diseases that demand acute, effective treatment of sleep apnea
  • Pharyngeal soft tissue abnormalities
  • Living to far away from the University Hospital
  • Professional drivers
  • Pregnancy
  • Included in other studies
  • Other sleep apnea treatments
  • Severe craniomandibular disorders
  • Acute or advanced periodontal disease
  • Insufficient number of teeth

结局指标

主要结局

Sleep apnea and sleep measured by polysomnography

时间窗: Baseline and after 4 months

Daytime sleepiness and sleep apnea symptoms assessed in questionnaires and objective testing

时间窗: Baseline and after 4 months

Quality of life

时间窗: Baseline and after 4 months

次要结局

  • Markers of inflammation(Baseline and after 4 months)
  • Markers of cardiovascular health and oxidative stress(Baseline and after 4 months)
  • Side-effects from the treatment(After 4 months treatment)
  • Predictors of effects on symptoms and sleep apneas(After 4 months treatment)
  • Headaches(Baseline and after 4 months)
  • Blood pressure(Baseline and after 4 months)
  • Vigilance(Baseline and after 4 months)
  • Markers of stress(Baseline and after 4 months)

研究者

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

Marie Marklund

Associate professor

Umeå University

研究点 (2)

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