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临床试验/NCT06810479
NCT06810479已完成不适用

A Randomised, Controlled Cross Over Study Comparing Two Mandibular Advancement Devices in the Treatment of Mild-to-moderate Obstructive Sleep Apnea

Ziekenhuis Oost-Limburg1 个研究点 分布在 1 个国家目标入组 16 人开始时间: 2025年3月21日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
16
试验地点
1
主要终点
AHI

研究概览

简要总结

The goal of this randomised, controlled cross-over study is to compare two mandibular repositioning devices (MRA) already on the market in the treatment of mild-to-moderate obstructive sleep apnea.

Patiënt will test the first MRA for 3 months, after a wash out period of 2 weeks they will test the second MRA for 3 months. It will be randomised what type of MRA will be tested first and second.

详细描述

A mandibular repositioning appliance (MRA) is the primary treatment option for patients with mild to moderate obstructive sleep apnea (OSA), as well as for those with severe OSA who are intolerant to continuous positive airway pressure (CPAP) therapy or for whom surgical interventions are not viable. MRAs function by advancing the mandible, thereby increasing the volume of the upper airway and reducing its tendency to collapse during sleep. Various types of MRAs are available, and multiple classification systems can be employed to distinguish between these different types.

Mandibular repositioning appliances (MRAs) can be either custom-made or universal. Custom-made devices, which are typically more expensive, are fabricated in a dental laboratory using dental impressions. In contrast, prefabricated devices, often thermoplastic MRAs, are generally less costly and readily available over the counter.

Mandibular repositioning appliances (MRAs) can be classified as non-titratable, also known as monoblock devices, which have a fixed position, or titratable devices, which allow for gradual adjustment of the mandibular position until the desired therapeutic effect is achieved. Current guidelines recommend the use of titratable MRAs.

Titratable mandibular repositioning appliances (MRAs) can be further categorized into two types: midline traction devices, where the upper and lower components are connected at the front of the device, and bilateral thrust devices, where the upper and lower components are linked in the lateral or (pre-)molar regions.

Within the latter category, various designs exist, including devices that are adjustable on both sides using Hyrax screws and 3D-printed devices equipped with a series of lower components that allow for adjustments in mandibular position.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Treatment
盲法
Single (Outcomes Assessor)

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

  • •In order to be eligible to participate in this study, a subject must meet all of the following criteria:
  • •Provide signed and dated informed consent
  • •Males or females aged 18 and above
  • •Apnea-Hypopnea Index (AHI) between 5 and 30 events per hour diagnosed by a polysomnography
  • •A potential subject who meets any of the following criteria will be excluded from participation in this study:
  • •Previous surgery on the upper airways
  • •Prior treatment of OSA (CPAP or MRA)
  • •Presence of unstable cardiovascular conditions, neurological, mental, or psychiatric disorders
  • •Insufficient dental or periodontal condition for a mandibular repositioning appliance (MRA)
  • •Presence of temporomandibular joint dysfunction

排除标准

  • 未提供

研究组 & 干预措施

MRA1MRA2

Experimental

Use of MRA device 1 for 3 months, use of MRA device 2 for 3 months

干预措施: Polygraphy (Diagnostic Test)

MRA1MRA2

Experimental

Use of MRA device 1 for 3 months, use of MRA device 2 for 3 months

干预措施: Questionaire (Other)

MRA1MRA2

Experimental

Use of MRA device 1 for 3 months, use of MRA device 2 for 3 months

干预措施: Question (Other)

MRA2MRA1

Experimental

Use of MRA device 2 for 3 months, use of MRA device 1 for 3 months

干预措施: Polygraphy (Diagnostic Test)

MRA2MRA1

Experimental

Use of MRA device 2 for 3 months, use of MRA device 1 for 3 months

干预措施: Questionaire (Other)

MRA2MRA1

Experimental

Use of MRA device 2 for 3 months, use of MRA device 1 for 3 months

干预措施: Question (Other)

结局指标

主要结局

AHI

时间窗: 3 monthts after use of first MRA (mandibular advancement device), 3 months after use of second MRA (mandibular advancement device)

Improvement of AHI (apnea-hypopnea index), measured by polygraphy before treatment and after treatment with each MRA. The goal of the mandibular advancement device is to reduce the number of apneas and hypopneas per hour, apneas are periods when a person stops breathing and hypopneas are instances where airflow is blocked, causing shallow breathing. This is measured by a polygraphy-test overnight at the patiënts home.

次要结局

  • Patient experience questionnaire(3 months after use of the first MRA, 3 months after use of the second MRA)
  • Peripheral oxygen saturation 1(3 monthts after use of first MRA, 3 months after use of second MRA)
  • Peripheral oxygen saturation 2(3 monthts after use of first MRA, 3 months after use of second MRA)
  • Peripheral oxygen saturation 3(3 monthts after use of first MRA, 3 months after use of second MRA)
  • ESS(3 monthts after use of first MRA, 3 months after use of second MRA)
  • Final choice(after the use of each MRA for 3 months)

研究者

发起方
Ziekenhuis Oost-Limburg
申办方类型
Other
责任方
Sponsor

研究点 (1)

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