Effects of an Oral Appliance on Obstructive Sleep Apnea: A Randomized, Placebo-Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 64
- 试验地点
- 2
- 主要终点
- apnea-hypopnea index (AHI)
研究概览
简要总结
The aim of the study was to compare the effects of a mandibular advancement device (MAD) with those of nasal continuous positive airway pressure(nCPAP) and of an intra-oral placebo device in obstructive sleep apnea (OSA) patients. The hypothesis for this study was that both MAD therapy and nCPAP therapy have similar, better treatment effects than placebo therapy in OSA. The study was performed according to the CONSORT (consolidated standards of reporting trials) statement (Altman et al., 2001), employing a parallel-group, randomized, placebo-controlled trial design.
详细描述
Setting and participants:
Eligible OSA patients, living in the greater Amsterdam area, were referred to the Slotervaart Medical Center by their family physician. All patients underwent a thorough medical examination, including a full polysomnographic (PSG) recording, at the departments of Neurology, Pulmonary Medicine, and ENT, as well as a thorough dental examination at the Department of Oral Kinesiology of ACTA. OSA patients were invited for participation in this study when they fulfilled the inclusion criteria and exclusion criteria.
Randomisation and allocation:
After written informed consent was obtained, the patients were randomly allocated to one of three therapy groups (MAD, nCPAP, or placebo; see below). To ensure that the groups were of approx. the same size, block randomisation was used. Block sizes were 6, 12, and 18; sizes were randomly varied. The allocation sequence was automatically generated and subsequently concealed by an independent co-worker, who kept a paper copy in a lockable drawer. Sealed opaque envelopes were used to conceal the allocation from the principal investigator.
Interventions and blinding:
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 (Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •age > 18 years
- •apnea-hypopnea index (AHI) between 5 and 45 events per hour
排除标准
- •evidence of respiratory/ sleep disorders other than obstructive sleep apnea
- •a body mass index (BMI) > 40
- •medication usage that could influence respiration or sleep
- •periodic limb movement disorder
- •previous treatment with CPAP or MAD
- •reversible morphological upper airway abnormalities (e.g., enlarged tonsils)
- •temporomandibular disorders (based on a functional examination of the masticatory system)
- •untreated periodontal problems
- •dental pain
- •lack of retention possibilities for a mandibular advancement device or a placebo appliance
结局指标
主要结局
apnea-hypopnea index (AHI)
时间窗: 6 months
次要结局
- other respiratory variables (apnea-hypopnea index during different sleep stages and positions);sleep variables (sleep stages and arousals);excessive daytime sleepiness;health perception;compliance;snoring reports; side-effects(6 months)
研究者
Ghizlane Aarab
Dr.
VU University of Amsterdam