Acceptance and Side Effects of Two Different Mandibular Advancement Devices (MADs) in the Treatment of Obstructive Sleep Apnea Syndrome (OSAS)
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 发起方
- 入组人数
- 28
- 试验地点
- 2
- 主要终点
- Acceptance of the MAD
研究概览
简要总结
Background: Obstructive sleep apnea syndrome (OSAS) is a prevalent condition with significant comorbidities. Mandibular advancement devices (MADs) are an established alternative for patients intolerant to continuous positive airway pressure (CPAP) therapy. However, potential side effects, particularly within the craniomandibular system, warrant further investigation.
Objective: This randomized controlled Phase IV trial aims to compare two different MAD designs (UPS-1 by Scheu Dental and UPS-2 by Panthera X3) in terms of patient acceptance, wearing comfort, adherence, and side effects, especially occlusal changes and temporomandibular discomfort, in OSAS patients over a 12-month period.
Methods: Twenty-eight patients will be stratified by sex and randomized 1:1 into two treatment groups. Assessments include acceptance of the MAD, clinical and digital occlusal analysis (GEDAS), functional examination (DC/TMD), sleep parameters (AHI, ESS, DI), and patient-reported outcomes. Follow-ups were scheduled at 4 weeks, 6 months, and 12 months post-insertion. Data were collected using standardized CRFs and validated questionnaires. Statistical analysis was based on ordinal regression and intention-to-treat and per-protocol populations.
Results & Conclusion: This study will provide evidence on the comparative efficacy and tolerability of two distinct MAD systems, contributing to improved treatment selection in personalized OSAS management.
详细描述
Partial obstruction of the upper airway during sleep leads to snoring in approximately 40% of men and 24% of women. Epidemiological studies indicate that 50% of these individuals suffer from obstructive sleep apnea syndrome (OSAS) (1, 2).
Sleep-related breathing disorders (SRBD), particularly OSAS, are among the most common causes of non-restorative sleep and sleep disorders. Characteristic patterns include apneas and hypopneas, which may occur with or without pharyngeal obstruction and hypoventilation. Depending on the type of breathing disorder, they may be associated with hypoxemia and can lead to hypercapnia or acidosis.
The consequences of obstructive pharyngeal narrowing are far-reaching. Studies have demonstrated that patients with OSAS frequently experience comorbidities such as neurological disorders, myocardial infarctions, dementia, cardiovascular diseases, and higher mortality rates (3-8). Sleep fragmentation due to nocturnal breathing disturbances and arousals may result in daytime sleepiness and impaired concentration. In the long term, untreated apneas and arousals increase the risk of arterial hypertension, stroke, myocardial infarction, diabetes mellitus, and reduced libido.
Therapeutic options during sleep include continuous positive airway pressure (CPAP) therapy, mandibular advancement devices (MADs), positional therapy, weight reduction, surgical interventions in the ENT region, bimaxillary or mandibular osteotomies, and hypoglossal nerve stimulation.
The choice of therapy depends on the severity of OSAS. For mild to moderate OSAS, MADs, positional therapy, and weight loss are viable options. In severe OSAS, CPAP therapy remains the gold standard. Osteotomies, offering effects comparable to CPAP, and hypoglossal nerve stimulation are reserved for specific clinical cases. In certain cases, a multimodal approach, including surgical methods, may be appropriate regardless of OSAS severity.
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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Medical indication for MAD therapy due to OSAS
- •Mandibular advancement of at least 5 mm possible
- •Fixed prosthetics or stable removable partial dentures
- •Bilateral support extending to at least the second premolars
- •Legal capacity and signed informed consent
排除标准
- •Polyarthritis
- •Mouth opening < 30 mm
- •More than two prior therapy attempts
- •Fibromyalgia, neuralgia
- •Central sleep apnea syndrome
- •Pulmonary diseases
- •Untreated generalized periodontitis
- •Chronic dysfunctional pain (GCPS Grade 3-4)
- •Long-term use of psychotropic or analgesic medications
研究组 & 干预措施
Patients randomly selected for arm 1 MAD treatment
Patients with primary snoring or with a medical indication for MAD therapy due to OSAS. Patients age must be ≥ 18 and ≤ 75 years. Patients must have a mandibular advancement of at least 5 mm possible (titration starts at 5 mm). Patients must have at least 8 teeth or 4 implants per jaw or with fixed prosthetics or stable removable partial dentures, bilateral support extending to at least the second premolars.
干预措施: MAD of the Scheu Dental type with lateral guidance wings (MAD-1) (Device)
Patients randomly assigned to arm 2 MAD treatment.
Patients with primary snoring or with a medical indication for MAD therapy due to OSAS. Patients age must be ≥ 18 and ≤ 75 years. Patients must have a mandibular advancement of at least 5 mm possible (titration starts at 5 mm). Patients must have at least 8 teeth or 4 implants per jaw or with fixed prosthetics or stable removable partial dentures, bilateral support extending to at least the second premolars.
干预措施: MAD of the Panthera X3 type with lateral guidance wings (MAD-2) (Device)
结局指标
主要结局
Acceptance of the MAD
时间窗: 4 weeks, 6 months, 12 months
wearing comfort of the MAD, assessed using a numeric rating scale (NRS; 0-10) at follow-up time points
次要结局
- Orofacial Pain(4 weeks, 6 months, 12 months)
- Pressure Pain in the Temporomandibular Joint and Masticatory Muscles(4 weeks, 6 months, 12 months)
- Number of Posterior Contact Points(4 weeks, 6 months, 12 months)
- GEDAS (Greifswald Digital Analyzing System)(12 months)
研究者
Olaf Bernhardt
Prof. Dr. med. dent.
University Medicine Greifswald